Nanotech,Biotech, Biomed and Pharmaceutical News

GlaxoSmithKline and Theravance announce expansion of the Horizon programme with start of large Phase 2B study of LABA in COPD patients

2008-02-26T13:56:00.000-08:00

GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the expansion of the Horizon programme into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD). A large Phase 2b COPD dose-optimisation study with the lead long-acting beta agonist (LABA) GW642444 (‘444) has commenced, with screening of the first patient undertaken.

This is in addition to the four large Phase 2b asthma dose-optimisation studies; one with ‘444 and three with the lead inhaled corticosteroid (ICS) GW685698 (‘698), which commenced in December 2007, as part of the ongoing Horizon programme.

Darrell Baker, SVP GSK Respiratory Medicines Development Centre said, “Delivering a once-daily treatment for asthma and COPD, where there remains a considerable unmet need, is a priority. We believe that this is an important milestone within the Horizon programme and we eagerly await results from the ongoing asthma and now COPD studies that will help guide future development of these important assets.”

“We are very pleased to have initiated the larger Phase 2b study with the lead compound ‘444 in COPD," said Rick E Winningham, Chief Executive Officer at Theravance. “With ‘444 now in large Phase 2b studies in both asthma and COPD, we have met two important targets that bring us closer to our joint goal of bringing a new treatment option to patients in these important therapeutic areas."

Study design
This double-blind, placebo controlled trial will enrol approximately 600 patients with moderate to severe COPD from study centres across the USA, Europe and international locations. Each patient will be randomised to receive a once-daily dose of placebo or ‘444 via a novel inhaler throughout the 28-day treatment period. The primary endpoint of the study will be efficacy, evaluated by change from baseline FEV1 (pre-bronchodilator and pre-dose) at the end of the 28-day treatment period, with a number of secondary endpoints also evaluated.

These study data, taken together with the data obtained from parallel studies currently being undertaken with ‘698, will be used to guide future development plans in COPD and progression into large-scale Phase 3 COPD combination studies. No Phase 2b COPD monotherapy studies with ‘698 will be undertaken as part of the Horizon programme.

About GSK
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.

About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the six programs in development, four are in late stage - its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, the Gastrointestinal Motility Dysfunction program, and TD-1792, an investigational antibiotic for the treatment of serious Gram-positive bacterial infections. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com. THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

Medtronic Statement Regarding Senate Hearings on Industry And Physician Relationships

2008-02-26T13:55:00.000-08:00

In advance of hearings on Wednesday, February 27, in the Senate Special Committee on Aging, Medtronic, Inc. (NYSE:MDT), today issued the following statement:

On Wednesday, February 27, the Senate Special Committee on Aging will explore relationships between industry and physicians and consider the proposed “Sunshine Act” (S.2029) introduced earlier this year by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI).

The Sunshine Act would require industry to publicly disclose via the Internet certain payments made to physicians in return for their time and expertise with product development, research and training. For decades, the innovative power and clinical expertise of physicians have produced technologies that industry has brought to patients around the world, and Medtronic believes these vital collaborations must be protected

The Sunshine Act is aimed at curbing inappropriate relationships or conflicts of interests between industry and physicians, an effort that Medtronic – one of the world’s leading medical technology companies – supports.

Medtronic believes, however, the bill can and should go even further by requiring the same level of disclosure by all companies in the industry, regardless of size and including those companies owned in whole or in part by physicians. Companies with yearly revenues less than $100 million and physician-owned companies are currently excluded from the bill, and they account for more than 75 percent of the companies in the industry.

Medtronic believes a level playing field for all companies is appropriate and that these entities should operate under the same disclosure requirements, recognizing that transparency can help alleviate any real or perceived conflicts of interest with these types of companies as well.

“We have been pleased to work with the members of the Senate Special Committee on Aging, the Senate Finance Committee, and members of the House of Representatives and Senate on this legislation,” said Bill Hawkins, president and CEO of Medtronic. “We will continue to work with the sponsors of this legislation to incorporate all companies in the industry into the bill and bring greater transparency to these important relationships.”

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Invitrogen Renews, Expands License and Supply Agreement with Luminex

2008-02-12T09:22:00.000-08:00

Invitrogen Corporation (NASDAQ: IVGN), a provider of essential life science technologies for research, production and diagnostics, and Luminex Corporation (NASDAQ: LMNX), today announced the renewal and expansion of Invitrogen's license and supply agreement for Luminex's multiplexed analyte detection technology and systems. The new agreement extends the lifetime of the license and provides Invitrogen with access to Luminex's next-generation multiplex detection platforms.

xMAP(R) Technology and Luminex instrument platforms use proprietary microspheres - micron-sized beads - encoded with combinations of spectrally distinct fluorescent dyes to rapidly and reproducibly determine the relative concentrations of many different proteins or peptides at the same time in the same sample.

Invitrogen offers more than 200 assays based on xMAP Technology, comprising the most comprehensive multiplex protein assay menu in life sciences for cellular pathway and disease analysis. Invitrogen also has a large number of new multiplexed assays in its product development pipeline to expand the number of targets accessible to scientists. The company will offer custom assay development services using the next-generation platform that complement its existing service of rapid, affordable multiplex assay development on the original Luminex platform.

"We are pleased with this new agreement and committed to our relationship with Luminex," said Kip Miller, Invitrogen's Senior Vice President, BioDiscovery. "It is another step in our strategy of building on our position as the leading cell biology reagent provider to offer our customers integrated systems and solutions."

"We believe the extension of the agreement is beneficial for both companies, as Luminex has quickly become a standard in the industry for multiplexing and Invitrogen has the ability to offer the broadest array of content for this important platform," added August Sick, Invitrogen Vice President and General Manager, Cellular Analysis Business Unit. "The assays we will develop on Luminex's next-generation platform will further accelerate drug discovery and cellular analysis."

"Luminex is pleased to extend and expand our relationship with Invitrogen," said Doug Bryant, executive vice president and chief operating officer of Luminex. "Partnering with innovative leaders such as Invitrogen is a key element in our business strategy. We look forward to a valuable, long-term collaboration with Invitrogen."

Invitrogen, Agilent Technologies Settle Multiple Patent Litigations

2008-02-05T13:46:00.000-08:00

Invitrogen Corporation and Agilent Technologies have jointly announced a confidential settlement of multiple patent litigations pending between the two companies. The settlement resolves three patent infringement lawsuits between Invitrogen and Stratagene, Inc. Agilent acquired Stratagene in 2007.

These patent litigations between the companies had been pending since 2000 and 2001. In June 2000, Invitrogen sued Stratagene in the United States District Court for the District of Maryland, Southern Division, for infringement of Invitrogen's U.S. Patent Nos. 6,063,608, 5,244,797, and 5,405,776 relating to the use and sale of RNase H minus reverse transcriptase (RT) products. This case had been stayed pending resolution of a related litigation with Clontech.

On March 12, 2001, Invitrogen filed suit against Stratagene for infringement of U.S. Patent No. 4,981,797. That patent covers a process for producing E. coli cells that are more effective at absorbing foreign DNA and thereby more "competent." In 2006, the United States District Court for the Western District of Texas, Austin Division, entered judgment awarding Invitrogen $16.2 million plus prejudgment interest, post-judgment interest, attorneys' fees and costs, and entered an injunction against further infringement. Stratagene appealed the judgment to the United States Court of Appeals for the Federal Circuit.

In November 2001, Stratagene filed suit against Invitrogen in the United States District Court for the District of Maryland, Southern Division, for infringement of U.S. Patent No. 5,556,772 related to the use and sale of certain DNA polymerase blend products. The case had been stayed by the Court pending a reissuance proceeding before the United States Patent Office.

Under the terms of the agreement, Agilent will make an undisclosed settlement payment to Invitrogen. In addition, Agilent will discontinue sales of its RNase H minus RT products and Invitrogen will obtain a license from Agilent and pay an undisclosed royalty to sell its DNA polymerase blend products. All litigation will be dismissed. No other details of the settlement were disclosed.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.3 billion in 2007. For more information, visit www.invitrogen.com.

About Agilent Technologies

Agilent Technologies Inc. (NYSE: A) is the world's premier measurement company and a technology leader in communications, electronics, life sciences and chemical analysis. The company's 19,000 employees serve customers in more than 110 countries. Agilent had net revenues of $5.4 billion in fiscal 2007. Information about Agilent is available on the Web at www.agilent.com.

Study Suggests Risperidone Long-Acting Injection Combined with Standard Treatment Helped Delay Time to Relapse in Patients with Bipolar Disorder

2008-02-05T12:14:00.000-08:00

Patients with frequently relapsing bipolar disorder had a significant delay in the time to an initial relapse when risperidone long-acting injection (RLAI) was combined with standard treatment, according to a new study. The study compared patients who received RLAI and standard treatment to those who received standard treatment combined with placebo.

The study was presented yesterday at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disordersin Montreux, Switzerland.1 This one-year, phase 3, trial is the first placebo-controlled study to explore the use of a long-acting injection medication in the maintenance treatment of frequently relapsing bipolar disorder (FRBD). FRBD, defined as four or more manic or depressive episodes in the previous year that require a doctor's care, may affect 20% of the 27 million people with bipolar disorder worldwide.2, 3

The study compared the time to the next mood episode, also known as a relapse, in FRBD patients receiving RLAI plus standard treatment vs. patients receiving placebo plus standard treatment. For most patients, standard treatment consisted of mood stabilizers, antidepressants, anxiolytics or combinations thereof. The trial showed that time to relapse was significantly longer in patients receiving RLAI compared with placebo (p=0.004) and the relative risk of relapse was 2.4 times higher with placebo. The relapse rates were 47.8% with placebo and 22.2% with RLAI.

"Patients with frequently relapsing bipolar disorder require more healthcare interventions than patients with fewer episodes, and there is a huge unmet need for new treatments," said Dr. Joseph Calabrese, Co-Director of the Bipolar Disorders Research Center, University Hospitals Case Medical Center, Case Western Reserve University. Dr. Calabrese is a consultant to the study sponsors, Ortho-McNeil Janssen Scientific Affairs, L.L.C. "Risperidone long-acting injection is administered once every two weeks by a healthcare professional and avoids the need for patients to remember to take daily antipsychotic medications. "

In the study, 139 patients were randomized to receive either RLAI 25-50mg intramuscular injection (n=72), or placebo injections (n=67) adjunctive to standard treatment. Patients receiving RLAI plus standard treatment were eligible to enter the double blind phase of the trial if they met predefined criteriaa for being stable the last four weeks of the 16-week open-label stabilization phase.

In the study, Frequently Relapsing Bipolar Disorder: Evidence for an Effective Treatment Using Adjunctive Risperidone Long-Acting Injectable, 67% of patients randomized received a 25 mg dose of RLAI, 29% received a 37.5 mg dose and 4% received a 50 mg dose, administered once every two weeks.

The primary efficacy endpoint in the double-blind phase of the trial was the time from randomization to relapse, where relapse was defined as the first occurrence of a mood episode as determined by an independent Relapse Monitoring Board (RMB).b

The results showed a significant difference in time to relapse (p=0.004), with a more than two-fold higher risk of relapse in the placebo group (47.8%) than the RLAI group (22.2%). In addition, scores on the Clinical Global Impression–Bipolar–Severity (CGI-BP-S) scale for overall bipolar disorder and the Clinical Global Impression-Bipolar-Change (CGI-BP-C) scale worsened significantly (p<0.05) in the placebo group compared with the RLAI group.

Treatment-emergent adverse effects (TEAEs) occurred more frequently in the group that received placebo and standard treatment (76.1%) than in the group that received RLAI and standard treatment (70.8%), as did serious adverse effects (placebo=19.4%; RLAI = 13.9%). The most common TEAEs (greater than 5%) in the double-blind phase were tremor (RLAI = 23.6%; placebo = 16.4%), insomnia (RLAI = 19.4%; placebo = 23.9%), muscle rigidity (RLAI = 11.1%; placebo = 6%); weight gain (RLAI = 6.9%; placebo = 1.5%) and hypokinesia (RLAI = 6.9%; placebo = 0%). A total of 5 patients discontinued due to adverse events in the double-blind phase (3 in the RLAI group and 2 in the placebo group).

Risperidone long-acting injection is marketed in the U.S. by Janssen, Division of Ortho-McNeil Janssen Pharmaceuticals, Inc. The formulation is manufactured by Alkermes, Inc. (Nasdaq: ALKS). Ortho-McNeil Janssen Scientific Affairs, LLC, funded the study.

About Bipolar Disorder

It is estimated that 27 million people worldwide2 suffer from bipolar disorder, also known as manic-depressive disorder. It is characterized by debilitating mood swings, from extreme highs (mania) to extreme lows (depression). Signs of mania include euphoria, extreme irritability or rage, accelerated or disorganized thinking and an increase in risky behaviors. Signs of depression include intense sadness or despair, loss of energy, insomnia and suicidal thoughts.

A classification of patients identified as "rapid-cycling" and also having four or more episodes during the previous 12 months, is estimated to occur in approximately 10-20% of patients with bipolar disorder seen in mood disorder clinics. The types of mood episodes (manic, depressed, mixed) seen in these patients can occur in any pattern. The course of their illness is characterized by a requirement for more health care resources, more concomitant medications and poorer outcomes.4

About Risperidone Long-Acting Injection

Risperidone long-acting injection is the first and only long-acting, atypical antipsychotic to be approved by the U.S. Food and Drug Administration and now is approved in more than 70 countries worldwide. The treatment uses Alkermes proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Janssen markets Risperidone long-acting injection in the United States. The formulation is manufactured by Alkermes, Inc. (Nasdaq: ALKS). Available in 12.5 mg, 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia. For more information about RISPERDAL CONSTA, visit www.risperdalconsta.com.

Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is based in Titusville, N.J. and is the only large pharmaceutical company in the U.S. dedicated solely to mental health. As the company celebrates its 50th year in mental health, it currently markets prescription medications for the treatment of schizophrenia, bipolar mania and the treatment of symptoms associated with autistic disorder. For more information about Janssen, visit www.janssen.com.

Alkermes, Inc. is a biotechnology company that uses proprietary technologies and know-how to create innovative medicines designed to yield better therapeutic outcomes for patients with serious disease. Alkermes manufactures RISPERDAL® CONSTA®, marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and Janssen-Cilag, a subsidiary of Johnson & Johnson, outside of the U.S. Alkermes also developed and manufactures VIVITROL®, marketed in the U.S. primarily by Cephalon, Inc. The company's pipeline includes extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Alkermes is headquartered in Cambridge, Massachusetts, with research and manufacturing facilities in Massachusetts and Ohio. For more information about Alkermes, visit www.alkermes.com.

a Stable remission was achieved if, during the last 4 weeks of the 16-week OL stabilization phase the subject had not met DSM-IV-TR criteria for active mood disorder; the subject had no crisis interventions; the subject’s Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS) total scores both remained ≤10 and the Clinical Global Impression – bipolar severity (CGI-BP-S) score remained ≤ 3 and the subject’s medications and doses of other psychotropic medications remained unchanged.

b RMB = a fully independent, blinded, international board of 3 psychiatrists considered experts in the treatment of bipolar disorder. They reviewed all clinical data and determined whether the patient met relapse criteria.

References

1 Aphs L, Kujawa M, Macfadden W et al., Frequently relapsing bipolar disorder: evidence for an effective treatment using adjunctive risperidone long-acting injectable, presented at the 14th Biennial Winter Workshop on Schizophrenia, Montreux, Switzerland, February 2008.

2 The Global Burden of Disease. World Health Organization, 2003. Available at
http://www.who.int/mip/2003/other_documents/en/globalburdenofdisease.pdf, accessed January 18, 2008

3 DSM-IV-TR, American Psychiatric Association, 2000.

4 DSM-IV, American Psychiatric Association, 2000

GlaxoSmithKline and Synta announce elesclomol granted US orphan drug designation by the FDA

2008-01-28T13:49:00.000-08:00

GlaxoSmithKline (GSK) and Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to elesclomol (formerly STA-4783) for the treatment of patients with metastatic melanoma. Elesclomol is being developed under a global collaboration agreement between Synta and GSK. Elesclomol is an investigational drug that is not approved for any indication in any market at this time.

Orphan drug status is designed to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the United States. In November 2006 elesclomol received Fast Track designation from the FDA for development in metastatic melanoma.

“We are pleased that the FDA granted elesclomol orphan drug status for the treatment of metastatic melanoma,” said Eric Jacobson, M.D., Senior Vice President and Chief Medical Officer, Synta Pharmaceuticals. “With the incidence of melanoma increasing more rapidly than any other cancer during the past ten years, there is a significant need for innovative therapies such as elesclomol.”

“Orphan drug status is an acknowledgment of the significant need to develop new therapies for patients with metastatic melanoma, a disease for which there are few treatment options,” said Paolo Paoletti, Senior Vice President of the OncologyMedicineDevelopmentCenterat GSK. “Through the development of products like elesclomol, GSK Oncology is reaffirming its commitment to address clinical needs in cancer treatment and improve the lives of patients.”

About elesclomol (formerly STA-4783)

Elesclomol is a novel, injectable, investigational drug candidate that is believed to kill cancer cells by elevating oxidative stress levels beyond a breaking point, triggering programmed cell death. This mechanism of action, called oxidative stress induction, represents a novel way of selectively killing cancer cells.

A pivotal Phase 3 clinical trial of elesclomol in combination with paclitaxel in metastatic melanoma (the SYMMETRYSM trial) was initiated in October 2007 and Phase 2 trials in other indications, and in combination with other agents, are planned. Information about the SYMMETRY trial can be found at www.clinicaltrials.gov.

In a double-blind, randomised, controlled Phase 2b clinical trial in 81 patients with metastatic melanoma, elesclomol in combination with paclitaxel met the primary endpoint, doubling the median time patients survived without their disease progressing, compared to paclitaxel alone (p = 0.035). The most common adverse events in the elesclomol plus paclitaxel group included fatigue, alopecia, constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhoea, and anaemia.

About US orphan drug status

The Orphan Drug Act (ODA) provides economic incentives to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases which affect fewer than 200,000 people in the United States. Orphan drug designation entitles GSK and Synta to seven years of market exclusivity for elesclomol for the treatment of patients with metastatic melanoma. Additional incentives for orphan drug development include tax credits related to development expenses, reduction in FDA user fees and FDA assistance in clinical trial design.

About metastatic melanoma

The incidence of melanoma has increased more rapidly than any other cancer during the past ten years. According to the American Cancer Society, melanoma accounts for approximately five percent of all skin cancers but causes about 75% of all skin cancer-related deaths. An estimated 60,000 people will be diagnosed and nearly 8,200 people will die from melanoma this year in the USalone. If diagnosed and surgically removed while localised in the outermost skin layer, melanoma is potentially curable; however, for patients with metastatic disease, the prognosis is poor. Treatments are limited and the expected survival for patients with metastatic melanoma is only six to nine months.

About GlaxoSmithKline

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes collaborations with more than 160 cancer centers. GSK is developing a new generation of patient-focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.

About Synta Pharmaceuticals

Synta Pharmaceuticals Corp. is a biopharmaceutical company focused on discovering, developing, and commercialising small molecule drugs to extend and enhance the lives of patients with severe medical conditions, including cancer and chronic inflammatory diseases. Synta has a unique chemical compound library, an integrated discovery engine, and a diverse pipeline of clinical- and preclinical-stage drug candidates with distinct mechanisms of action and novel chemical structures. AllSynta drug candidates were invented by Synta scientists using our compound library and discovery capabilities. Synta has a partnership with GlaxoSmithKline for the joint development and commercialisation of elesclomol. For more information, please visit www.syntapharma.com.

Medtronic Announces Exclusive Licensing of Arbor Surgical Technologies Pericardial Heart Valve

2008-01-28T13:47:00.000-08:00

Medtronic, Inc. (NYSE:MDT) and Arbor Surgical Technologies, Inc. today announced an exclusive global licensing agreement under which Medtronic will manufacture, market and distribute Arbor’s bovine pericardial tissue heart valve technologies. In addition, Medtronic has acquired a minority stake in Arbor. Arbor retains its exclusive rights to the modular Trilogy™ Aortic Valve System and sutureless TRE™ implantation technologies.

“We are optimistic that Arbor’s pericardial valve design combined with Medtronic’s proprietary technologies will achieve best-in-class performance. I am truly excited about this opportunity and the ongoing strengthening of our Structural Heart Disease product offering.” said Dr. John Liddicoat, vice president and general manager of the Structural Heart Disease business at Medtronic, “No other comparable technology exists today.” Dr. Thomas Fogarty, Arbor’s chairman and co-founder, added, “I am pleased to be partnering with a company like Medtronic that has the ability to bring our technology to so many patients.”

The technology will complement Medtronic’s Structural Heart Disease therapy objectives, which are focused on developing effective options for valve disease, septal defects and atrial fibrillation. Medtronic anticipates that development of Arbor's technology will enable future pericardial valves to achieve similar industry-leading patient survival outcomes as has been achieved with the highly successful Hancock II® and third-generation Mosaic® and Freestyle® porcine valves. The company will continue to enhance its line of third-generation porcine valves, as well as invest in its transcatheter valve program. Medtronic anticipates manufacturing the valve in its existing production facilities.

Arbor’s heart valve technology was created by valve inventor Ernie Lane, designer of multiple pericardial valves currently on the market, to address several known failure modes exhibited in existing pericardial valve designs. “I was not satisfied with the durability of the existing pericardial valves and felt there to be room for improvement,” said Mr. Lane, Arbor’s co-founder. Arbor’s technology will facilitate the development of Medtronic’s first pericardial valve, which will complement its portfolio of porcine and mechanical heart valves.

According to the Millennium Research Group, more than 106,000 heart valves are expected to be implanted in the in the U.S. in 2008.

About Medtronic
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease.

About Arbor
Arbor Surgical Technologies, Inc., (www.arborsurgical.com) with facilities in Irvine and Portola Valley, CA (USA), is a privately held cardiovascular device company focused on the minimally invasive heart valve replacement market. Founded in 2002 by Dr. Thomas J. Fogarty and noted heart valve designer, Ernie Lane, Arbor is developing technologies intended to deliver significant clinical benefit to patients worldwide. The Trilogy™ Aortic Valve System and TRE™ attachment systems are designed to expand the use of minimally invasive heart valve procedures.

Unique Lens Material Helps Minimize Contact Lens Wearers' Discomfort And Dryness Symptoms Under Adverse Environmental Conditions, Study Shows

2008-01-28T13:46:00.000-08:00

New research suggests that a novel silicone hydrogel material could help keep contact lens wearers from discarding their contacts due to discomfort caused by feelings of dryness, the most commonly reported reason people discontinue contact lens wear. Using a controlled clinical model for evaluating dryness, researchers report that patients experienced less discomfort while wearing contact lenses made with senofilcon A (ACUVUE® OASYS™ Brand Contact Lenses) than they did either while wearing no lenses or while wearing their usual contact lenses in a controlled adverse environment. The findings appear in the current issue of Current Medical Research and Opinion.

Contact lens wearers frequently complain of sensations of eye discomfort and dryness associated with wearing their lenses. Roughly 51 percent of lapsed lens wearers cite discomfort as the primary reason they discontinued wearing their lenses. Forty percent attribute their contact lens abandonment to dryness.

"Most soft contact lenses materials have demonstrated a susceptibility to environmental factors which can lead to clinical symptoms normally associated with ocular dryness," says Sheila Hickson-Curran, Director, Medical Affairs, Vistakon. "In addition to humidity, variables such as air movement (wind), temperature, and blink-rate altering visual activities such as reading and computer use can exacerbate signs and symptoms of dryness in contact lens wearers."

"Senofilcon A has previously shown promising results for reducing lens-wear related symptoms of dryness and discomfort," she adds. "This study shows that contact lenses made with senofilcon A may be superior to other soft lens materials in terms of minimizing dryness symptoms associated with exposure to adverse environmental conditions. Senofilcon A was also found to reduce discomfort symptoms even beyond that experienced with no lens, indicating a protective effect."

About the Study

The purpose of the study was to compare the ability of ACUVUE OASYS™ (senofilcon A) contact lenses to wearer's habitual contact lenses to provide relief from ocular discomfort during contact lens wear in adverse environmental conditions.

Researchers used the Controlled Adverse Environment (CAE) model, a proprietary state-of-the-art model for conducting ocular dryness studies, to investigate dryness during contact lens wear. Typically incorporated into clinical trials studying ocular dryness, the CAE is used to exacerbate dryness symptoms in a reproducible, controlled manner by closely regulating humidity, temperature, airflow, lighting, and visual tasking. Acute ocular drying conditions are optimized in the CAE by using appropriate exposure times and requiring subjects to perform a visual task such as reading or working on a computer.

Eleven participants completed a single-center, double-masked, randomized, cross-over, CAE study. Participants were current, successful contact lens wearers with histories of ocular discomfort during lens wear in windy or dry environments.

Study participants underwent a total of three 75-minute CAE exposures during a two-week period – once with no lenses, once wearing a new pair of their habitual contact lenses, and once wearing senofilcon A contact lenses. Subjects were not permitted to use rewetting drops or tear substitutes for at least 12 hours prior to visits and were not allowed to wear their contacts for at least 72 hours prior to visits.

When wearing senofilcon A contact lenses, study participants reported significantly lower subjective ocular discomfort scores during exposure to a controlled adverse environment than they did when wearing their habitual contact lenses. Participants reported better mean discomfort scores across all time points during CAE exposure while wearing senofilcon A lenses (1.62 ± 0.71 points) than they did while wearing their habitual contact lenses (2.21 ± 0.80 points, p <0.05). Senofilcon A lenses also yielded significantly better mean overall discomfort scores versus no lenses (2.73 ± 0.79 points, p<0.0001)

The study was supported by funding from Vistakon®, Division of Johnson & Johnson Vision Care. Inc.

ACUVUE®, Brand Contact Lenses are indicated for vision correction. As with all contact lenses, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from VISTAKON®, Division of Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting ecp.acuvue.com (for eye care professionals) or www.acuvue.com (for consumers).

ACUVUE® OASYS™, and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

US Food and Drug Administration Approves RECOTHROM

2008-01-17T11:51:00.000-08:00

Bayer HealthCare announced today that its partner, ZymoGenetics Inc., received US Food and Drug Administration (FDA) approval of RECOTHROM™ Thrombin, topical (recombinant) for use as a topical hemostatic product. Bayer acquired the product rights for all markets outside the US in 2007 and will provide US sales support for a three-year period as part of a co-promotion agreement.
“The first regulatory approval of RECOTHROM is a significant signal of the product’s strong clinical data,” said Hans Bishop, Head of Bayer’s global Hematology/Cardiology Business Unit. “RECOTHROM is an attractive addition to our specialty pharmaceutical portfolio. Our partnership with ZymoGenetics demonstrates Bayer’s continued focus on working collaboratively with innovative biotechnology companies to develop and commercialize novel protein therapeutics.”

RECOTHROM, previously referred to as rThrombin, is the first and only recombinant, plasma-free thrombin approved for use as a topical hemostatic product. The FDA has approved RECOTHROM as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical.

The FDA approval of RECOTHROM triggers a US-Dollar 40 million milestone payment from Bayer to ZymoGenetics. ZymoGenetics will compensate Bayer HealthCare for its US sales efforts by paying a tiered commission of up to 20% on US sales and up to US-Dollar 20 million in sales bonus payments upon achievement of certain US sales levels during a three-year co-promotion period.

About RECOTHROM™
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

Invitrogen Enters Non-Coding RNA Licensing Agreement with IMBcom

2008-01-17T11:46:00.000-08:00

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, has entered into an exclusive license agreement with IMBcom Proprietary Limited Company to commercialize new non-coding ribonucleic acid (RNA) content predicted by a proprietary algorithm and experimentally validated by the University of Queensland, Australia. This expanded content will enable Invitrogen to provide the most comprehensive non-coding RNA product portfolio in the market and be the first company to provide this new content to the research community.

"MicroRNAs, which are the focus of current non-coding RNA research, are just one small subset of the non-coding RNA world," said Peter Welch director of research and development for Gene Expression Profiling at Invitrogen. "MicroRNAs have a discrete function in gene regulation, but the larger non-coding RNAs are involved in multiple roles such as cellular aging and protein assembly, in addition to simple gene regulation."

By combining the coding and non-coding sequences on the same microarray, researchers can obtain more information from a single sample to better reveal the relationship between non-coding RNA expression and mRNA expression. This is particularly important for scientists studying cancer and stem cells, for such RNAs have been implicated in both of these areas.

Researchers at the University of Queensland developed an algorithm that has predicted tens of thousands of unique human and mouse probe sequences relating to coding and non-coding RNA.

John Mattick, professor of Molecular Biology at the University of Queensland added, "It appears that we have misunderstood the nature of genetic programming in humans and other complex organisms. Most of the genome is transcribed, mainly into non-coding RNAs, which appear to comprise a hidden layer of gene regulation whose full dimensions are just beginning to be explored."

Invitrogen will commercialize these sequences over the next few years, allowing the company to expand its NCode(TM) microRNA microarray product line into the field of non-coding RNA profiling. Thus, for the first time, a commercial tool will be available to help scientists to identify the large complement of non-coding RNAs and study their function.

For more information, visit: www.invitrogen.com/ncode or www.imbcom.com.au.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About IMBcom Pty Ltd

IMBcom is The University of Queensland's company for commercialisation of the intellectual property arising from research conducted at The Institute for Molecular Bioscience (IMB).

Medtronic Launches AneuRx AAAdvantage Stent Graft on New Xcelerant® Hydro Delivery System in U.S for Minimally Invasive Treatment of Abdominal Aortic

2008-01-10T10:02:00.000-08:00

Continuing its record of innovation in endovascular therapies for aortic aneurysms, Medtronic, Inc. (NYSE: MDT), today announced the U.S. market launch of the AneuRx AAAdvantage® Stent Graft on the new Xcelerant® Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. In addition, Medtronic has also received approval from the U.S. Food and Drug Administration to introduce its latest generation of packaging materials for the launch of this product.

Present in an estimated 1.2 million people in the United States, an abdominal aortic aneurysm (AAA) is a dangerous bulge or weakening of the body’s main artery that can rupture with fatal consequences if left untreated. If detected before rupturing, AAAs with diameters of more than twice the size of the normal infrarenal aorta are typically treated with either open surgical repair or endovascular repair (EVAR). In contrast to open surgical repair, EVAR involves a minimally invasive procedure in which a tube-like sleeve called a stent graft is threaded through the femoral artery in a compressed state on a delivery system and expanded inside the aorta at the site of the aneurysm. Once in place, the sleeve creates a new path for blood flow, reducing pressure on the aneurysm. The delivery system is then removed. EVAR has been shown to be an effective therapy for AAA, with fewer post-operative complications and shorter recovery times than open surgical repair.

“The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair using the AneuRx AAAdvantage Stent Graft a treatment option for more patients with abdominal aortic aneurysms,” said Dr. Frank R. Arko, M.D., chief of Endovascular Surgery at the University of Texas Southwestern Medical Center in Dallas. “It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous.”

The Xcelerant Hydro Delivery System will be used with the AneuRx AAAdvantage Stent Graft, which was introduced in the United States in March 2006. In bench testing, the Xcelerant Hydro Delivery System was shown to generate 68 times less friction than the previous delivery system, which does not have the hydrophilic coating. Hydrophilic means “affinity for water”; because water is a major component of blood, the hydrophilic coating is designed to ease the delivery system’s passage through the artery.

In addition, the Xcelerant Hydro Delivery System features a uniquely integrated sheath that is tapered on both ends. This dual-taper sheath is designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall. The integrated sheath also contributes to the system’s low profile characteristics, which are intended to enable excellent tracking and access through small vessels.

“Experience remains the foundation of our innovations in endovascular therapy, and the Xcelerant Hydro Delivery System represents our latest innovative contribution to this exciting field,” said Katie Szyman, vice president and general manager of Medtronic’s Endovascular Innovations business. “Combined with the AneuRx AAAdvantage Stent Graft, Medtronic now offers U.S. endovascular physicians an even stronger option for their EVAR procedures.”

Medtronic has been an innovator and leader in the endovascular stent graft industry for more than a decade, as evidenced by more implants than any other company. Its long history includes more than 100,000 patients treated with aortic stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endovascular stent grafts in the industry. These include the AneuRx AAAdvantage Abdominal Stent Graft System in the United States, and the Talent Abdominal, Talent Thoracic and Valiant Thoracic Stent Graft Systems outside the United States.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Invitrogen Announces Acquisition of CellzDirect

2008-01-10T10:00:00.000-08:00

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, today announced it has entered into a definitive agreement to purchase privately-held CellzDirect, Inc., based in Research Triangle Park, North Carolina, in a cash transaction for approximately $57 million.

CellzDirect provides hepatocyte-based cell products and related services used in the testing of new drugs. Primary human hepatocytes are the most accepted model for predicting a compound's effects on enzymatic metabolism in the liver. Such testing, recommended by the Food and Drug Administration (FDA), can prevent costly failures in clinical trials. For this reason, CellzDirect's products are mainly used by pharmaceutical and biotech companies in research and development. Primary hepatocytes are also used in biomedical research to study liver diseases and to understand downstream implications of cellular function.

"CellzDirect's high-value products and services will greatly complement Invitrogen's market-leading portfolio of complete cell systems, including primary cells, media, matrices and growth factors," said Greg Lucier, Invitrogen's Chairman and Chief Executive Officer. "The purchase of CellzDirect follows our strategy of investing in high growth areas of the market, specifically specialty cell systems."

"CellzDirect has distinguished itself from other primary cell providers through scientific leadership, consultation with scientific and industry leaders, and constant communication with the medical community and regulatory bodies," added Nicolas Barthelemy, Invitrogen's Senior Vice President, Cell Systems.

CellzDirect was founded in 2001 and employs approximately 90 people at its sites in North Carolina and Austin, Texas. Twelve month revenue for calendar year 2007 is expected to be approximately $18 million.

"Combining with Invitrogen will enhance our already strong position in the primary cell market," said Scott Edelman, CellzDirect's Chief Executive Officer. "We expect CellzDirect's growth rates to benefit from cross-promotion and combination with Invitrogen's technologies for cell culture, molecular biology, and fluorescent detection, and from Invitrogen's world-class sales, marketing, and distribution capabilities."

The transaction is subject to customary closing conditions and is expected to close in the first quarter. The acquisition is expected to be EPS neutral in fiscal year 2008, becoming accretive in fiscal year 2009.

About Invitrogen Corporation

Invitrogen Corporation (NASDAQ: IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company employs approximately 4,700 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About CellzDirect, Inc.

CellzDirect, Inc. is a privately held bioscience company that was founded in 2001 and employees approximately 90 people at its sites in North Carolina and Austin, Texas. CellzDirect provides bio/pharmaceutical companies with quality cell products and services focused primarily on drug metabolism, drug-drug interactions and drug transporters. With CellzDirect's support, scientists are better able to conduct research that accelerates the discovery and development of safe and effective drugs. For additional information, please refer to the company's web site at www.cellzdirect.com or call 1-866-95CELLZ.

HP Helps Healthcare Providers Improve Patient Care, Regulatory Compliance with Medical Archiving Solution

2008-01-10T09:56:00.000-08:00

HP today introduced a specialized archiving platform to help global healthcare providers, hospitals and imaging clinics of all sizes meet rapidly expanding retention requirements for medical images.

With the HP Medical Archive solution (MAS) 3.0, healthcare providers can strengthen their focus on improving patient care while also adhering to strict compliance regulations by ensuring that medical image data is securely indexed, preserved and accessible.

Healthcare organizations are challenged with ensuring that patient safety remains their No. 1 priority in the face of increasing costs, labor shortages and reduced reimbursements for procedures. At the same time, the medical imaging storage market is doubling every 24 months due to growing volumes of diagnostic images, medical documents and lab reports.

Asante Health System, a major healthcare provider in southern Oregon and northern California, selected HP MAS to help improve patient care by providing greater access to critical patient information.

“Key factors that drove our decision to move forward with HP were the ability to ‘grow as you go,’ fast performance and seamless failover for business continuity, and the commitment that a company like HP provides,” said Michael York, senior systems engineer, Asante. “After implementing the HP Medical Archive solution, Asante is on target to achieve a 230 percent return on investment over a five year period.”

HP MAS 3.0 delivers factory-integrated HP ProLiant servers, HP StorageWorks SAN and MSA disk storage with indexing, policy management and search software to provide long-term retention of medical fixed content. The grid architecture of MAS satisfies the scalability and performance requirements of healthcare providers at an affordable price. The tiered storage of the MAS grid ensures healthcare providers can align the business value of images with appropriate retention policies.

“The need for online medical image archiving and storage has skyrocketed in the last few years, with IT staffers and technicians trying to cope with more data, more patients and more work,” said Robin Purohit, vice president and general manager, Information Management, Software, HP. “By bringing MAS to the ‘masses’ – small and large customers alike – we have dramatically increased the number of organizations that can benefit from having easy access to the right patient information at the right time. HP is empowering more healthcare providers to improve overall patient care.”

Enhanced capabilities of HP MAS 3.0

HP MAS 3.0 provides new or enhanced capabilities in three main areas:

Improves patient care

High Availability Gateway provides “always-on” grid access to medical images, documents and lab reports, even in the event of multiple site failures;
Image Management Layer support and certifications with more than 30 Picture Archiving and Communications Systems (PACS) vendors make it easier for physicians within a hospital or across a group of hospitals to access patient information and share diagnostic data when collaborating on a patient’s treatment.

Increases storage flexibility and reduces costs

Ability to create and manage multiple tiers of storage within the MAS grid – including SAN, SCSI, SATA and tape – enables alignment of storage costs and retention policies with clinical value of images;
New Compact product line option offers entry-level prices starting at $60,000 for organizations that do not require multi-tier archiving.

Enhances operational efficiency and regulatory compliance

Linux operating environment enables use of standard system management tools to simplify operations;
HP ProLiant DL320s storage servers in the Compact product line increase rack density and reduce data center footprint;
Encryption as a standard security feature helps protect patient privacy as medical images are transferred across local or remote networks.

Thomas Vaughan, director of IT Infrastructure, Roswell Park Cancer Institute (RPCI), explained his experiences with HP MAS. “At RPCI, we needed a solution that would improve storage capacity and performance, archive medical images, be highly scalable, meet HIPAA and other government regulations, and offer disaster recovery and business continuity,” said Vaughan. “When compared to other offerings that we examined, HP stood out as the one company that took care of all our needs.”

HP MAS 3.0 is currently available. More information about the HP Medical Archive solution is available at www.hp.com/go/mas.

About HP

HP focuses on simplifying technology experiences for all of its customers – from individual consumers to the largest businesses. With a portfolio that spans printing, personal computing, software, services and IT infrastructure, HP is among the world’s largest IT companies, with revenue totaling $104.3 billion for the four fiscal quarters ended Oct. 31, 2007. More information about HP (NYSE: HPQ) is available at http://www.hp.com.

Court of Appeals Upholds Verdicts in Favor of Cordis Corporation On Patents Infringed by Medtronic, Inc. and Boston Scientific Corporation

2008-01-08T12:02:00.000-08:00

The Court of Appeals for the Federal Circuit in Washington, D.C. today upheld two separate 2005 jury verdicts that found Medtronic, Inc. and Boston Scientific Corporation infringed coronary stent patents owned by the Cordis Corporation, a Johnson & Johnson company. Cordis now intends to ask the U.S. District Court in Delaware to reinstate the damages judgments of $271 million against Medtronic and $324 million against Boston Scientific, plus interest.

"We are very pleased that the Court of Appeals has recognized the validity of the prior verdicts," said Todd Pope, Worldwide President, Cordis Corporation. "We will urge the U.S. District Court to move expeditiously to reinstate the two previous damages judgments, along with the interest that has accrued during the appeals process."

Injunctive relief is not an issue because the infringing Medtronic and Boston Scientific stents are no longer on the market. In March of 2005, separate juries found that Medtronic's GFX and Microstent II infringed Cordis' Palmaz (762) and Schatz (984) patents, and that Boston Scientific's NIR stent infringed the Palmaz patent. The Palmaz and Schatz patents relate to the fundamental design of the first coronary stent developed and introduced by Cordis.

Both patent infringement cases were originally tried in 2000, with Cordis receiving favorable jury verdicts. After a series of procedural rulings and appeals, both cases were retried in March of 2005, with Cordis prevailing again.

Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.

Submission of Marketing Authorisation Application for VELCADE (bortezomib) in Europe

2008-01-08T11:59:00.000-08:00

Janssen-Cilag International NV, has submitted a Marketing Authorization Application to the European Medicines Evaluations Agency for the use of VELCADE® (Bortezomib) for the treatment of patients with previously untreated multiple myeloma (MM).

Millennium Pharmaceuticals, Inc., the Company's co-development partner, also submitted a supplemental New Drug Application (sNDA) with the United States Food & Drug Administration (FDA).

The submission is based on data from the randomised, international, open-label phase III VISTA (VELCADE® as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone) study, which compared VcMP with MP as a treatment for previously untreated patients. The study was conducted at 151 centres, enrolling 682 patients in 22 countries across Europe, North and South America, and Asia.

The primary endpoint was time-to-progression, with secondary endpoints including response rates, time to and duration of response, progression-free survival, overall survival, and measures of clinical benefit such as time to next therapy. Patients on the VELCADE®-based regimen experienced a 35 percent complete response rate, defined by complete disappearance of M-protein. Furthermore, responses were durable; median duration of response for complete responders was 24 months. The median time to next therapy or treatment, a measure of clinical benefit has not been reached. This is an important benefit for patients since they have time off medication after completing treatment in contrast to other therapies. After a median of 16.3 months follow-up, a survival benefit has already been demonstrated.

This study was featured earlier this month as an oral presentation at the American Society of Hematology (ASH) 49th Annual Meeting and Exposition in Atlanta, Georgia.

Multiple myeloma (MM) is the second most common blood cancer, representing approximately one percent of all cancers and two percent of all cancer deaths.1

In 2002, there were approximately 85,700 cases of MM worldwide.2

Only 30 percent of MM patients survive longer than five years,3 with more than 18,000 people in the European Union dying each year from the disease.

About VELCADE®

Currently VELCADE® is indicated in the EU as monotherapy for use in patients with progressive MM who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

VELCADE® is the market leader in treating relapsed multiple myeloma with over 85,000 patients treated worldwide. VELCADE® is being co-developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Millennium Pharmaceuticals, Inc. Millennium is responsible for commercialisation of VELCADE® in the U.S. Millennium and Ortho Biotech Inc. currently co-promote VELCADE® in the U.S. Janssen-Cilag companies are responsible for commercialisation in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialisation in Japan.

VELCADE®has a predictable safety profile and a favourable benefit–risk ratio. The most common side effects reported with VELCADE®include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy, which is reversible in the majority of patients.

About Janssen-Cilag
The Janssen-Cilag companies have a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at www.janssen-cilag.com.

1 www.multiplemyeloma.org.

2 GLOBOCAN 2002, www-dep.iarc.fr.

3 Brenner H. Lancet 2002; 360:1131-1135.

GlaxoSmithKline and Theravance announce start of large Phase 2B ICS and LABA studies for asthma in the Horizon programme

2008-01-03T07:26:00.000-08:00

GlaxoSmithKline Plc (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of large Phase 2b asthma dose-optimisation studies with both the lead inhaled corticosteroid (ICS) GW685698 (‘698) and the lead long-acting beta agonist (LABA) GW642444 (‘444) assets in the ‘Horizon’ programme to develop a next-generation combination product.

GSK began enrolling patients with mild to severe asthma in the ‘698 Phase 2b clinical programme on 21st December 2007and began enrolling patients with persistent asthma in the ‘444 Phase 2b clinical programme on 29th December 2007. These clinical programmes will determine the most effective doses to be taken into Phase 3 combination studies. The Phase 2b COPD programme with ‘444 is also on schedule to commence in 1H 2008.

Darrell Baker, SVP GSK Respiratory Medicines Development Centre said, “The programme is progressing well and we are delighted to have two very strong assets to progress into our large Phase 2b studies.” He continued, “We have seen encouraging results in previous studies and have confidence in our ongoing programme. Both asthma and COPD are serious, debilitating diseases where there remains a considerable unmet need. We believe through this programme we will introduce a meaningful option for the treatment of patients with these conditions.”

“We are very pleased to have met the important milestone of initiating the larger Phase 2b studies with the lead compound ‘444 and with the progress of ‘698," said Rick E Winningham, Chief Executive Officer at Theravance. “Based upon recent clinical and preclinical results, the collaboration’s confidence in the overall profile of ‘444 has increased and we are focusing our resources on this compound to move it forward as quickly as possible. This important step brings us closer to our joint goal of bringing a new treatment option to patients in this important therapeutic area."

These studies will enrol in excess of 2,400 patients recruited globally. The ‘444 LABA Phase 2b dose-optimisation study will enrol approximately 600 patients with persistent asthma who are receiving inhaled steroids. The ‘698 ICS Phase 2b studies will be undertaken in three separate studies in mild, moderate and severe asthma patients with a total enrolment of 1,800 patients. All studies will be carried out using a new inhaler device. In parallel, enabling studies involving ‘444 and ‘698 given in combination will be undertaken prior to commencing large-scale Phase 3 combination studies.

In a recently-completed Phase 2 study, ‘698 demonstrated once-a-day efficacy in patients with moderate asthma, with significant improvements in lung function in excess of 200mL seen within the first two weeks of dosing and maintained throughout the remainder of the 8 week treatment period, without any adverse effect on adrenal function (a marker of systemic steroid effect).

Darrell Baker concluded, “Our goal will be to offer patients the benefit of a once-daily medication to address a significant unmet patient need. As a leader in respiratory medicine, GSK is leveraging years of experience in the development of combination products with the goal of providing physicians and patients with an effective and innovative medicine.”

About GSK
GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit www.gsk.com.

About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the six programs in development, four are in late stage – its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc., the Gastrointestinal Motility Dysfunction program, the Horizon program (Beyond Advair collaboration) with GlaxoSmithKline plc, and TD-1792 for the treatment of serious Gram-positive bacterial infections. By leveraging its proprietary insight of multivalency toward drug discovery focused on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit the company's web site at www.theravance.com. THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

Confirma And GE Healthcare Expand Strategic Partnership

2007-12-18T12:12:00.000-08:00

for MRI, announced today that Confirma and GE Healthcare, the $17 billion global leader in medical imaging and information systems, have expanded their strategic partnership to offer Confirma service to GE Healthcare customers with CADstream. Under the new agreement, Confirma will offer program consultation, experienced applications training, customizable educational courses, and marketing and reimbursement consultation to GE Healthcare customers with CADstream, the standard in CAD for breast MRI.

Since July 2004, Confirma and GE Healthcare have partnered to bring the industry’s leading MRI technologies for breast cancer detection to healthcare providers. Under the agreement, GE Healthcare will continue to distribute CADstream to its MRI customers while Confirma will install, train and support CADstream. The expanded relationship marks significant progress in their mutual goal to advance MRI technology for breast cancer detection. Currently, over 200 CADstream systems have been installed at GE Healthcare customer sites worldwide.

“As physicians begin to offer breast MRI to their patients, there is increasing demand for a truly complete solution. In addition to providing excellent imaging and intervention capabilities, productive workflow and interpretation efficiency are critical to a complete offering. CADstream has been a key component of our solution for the past several years,” said David Handler, General Manager, MR Global Marketing, GE Healthcare. “We look forward to continuing to advance breast MRI together under the new arrangement.”

“This amendment demonstrates our commitment to GE Healthcare and its customers,” said Wayne Wager, President and CEO, Confirma. “We will offer customers expertise and support that continue to improve confidence in breast MRI.”

About Confirma Customer Support

Program Consultation and Experienced Applications

Confirma’s experienced customer service team provides expert consultation for early and advanced breast MRI programs. Additionally, Confirma’s customer support team provides comprehensive training at the customer’s site.

Using remote technology, Confirma’s customer service team can instantly access CADstream systems for service and updates. Confirma expert support is available via telephone 24 hours per day.

Customizable Educational Courses

Confirma supports a variety of CME-accredited breast MRI with CAD educational programs, including didactic and hands-on courses, online case reviews and fellowships led by experienced faculty.

Marketing and Reimbursement Consultation

Confirma offers marketing and reimbursement consultation to customers, including development of direct mail, physician referral brochures and press releases. Reimbursement consultation includes recommendations on program development, coding and appeals.

Advances in Breast MRI

Confirma and CADstream help imaging centers improve confidence in MRI and meet the rapidly-increasing demand for MRI studies. Recently-published clinical studies support breast MRI for improved breast cancer detection and in March 2007, the American Cancer Society started recommending that women with a 20-25 percent or greater lifetime risk of breast cancer undergo an annual MRI in addition to mammography.

It is becoming increasingly important to improve the analysis of these complex, time-consuming studies. CADstream is advancing breast MRI by improving efficiency of study interpretation and reporting. The system automates analysis, reporting and interventional planning of studies and promotes standardization with the incorporation of the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS®), which guides the breast cancer diagnosis and decision-making process. Confirma’s next-generation version of CADstream for breast MRI, launched at the RSNA 2007 meeting, includes a customizable BI-RADS®-centric user interface that accommodates a variety of experience levels.

CADstream was first introduced at the RSNA meeting in 2002 and is currently in use by thousands of physicians at hundreds of breast MRI programs around the world.

The July 2007 issue of Radiology published research from the University of Washington and Seattle Cancer Care Alliance indicating that CAD for breast MRI may improve standardization, as well as the analysis of benign and malignant lesions. CADstream was the only CAD system used in this study.

About GE Healthcare

GE Healthcare provides transformational medical technologies that will shape a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, disease research, drug discovery and biopharmaceuticals is dedicated to detecting disease earlier and tailoring treatment for individual patients. GE Healthcare offers a broad range of services to improve productivity in healthcare and enable healthcare providers to better diagnose, treat and manage patients with conditions such as cancer, Alzheimer’s and cardiovascular diseases. GE Healthcare is a $17 billion unit of General Electric Company (NYSE:GE) that is headquartered in the United Kingdom. Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit www.gehealthcare.com.

About Confirma, Inc.

Confirma develops and markets application-specific CAD systems and accessories for magnetic resonance imaging studies (MRI). CADstream is the standard in CAD for MRI, with more than 800 installations and 2,500 users worldwide. Confirma’s approach to CAD is unique: CADstream is developed with specific tools for each application in order to streamline workflow and standardize study analysis. CADstream automates the analysis and interventional guidance of MRI studies, providing higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. In its initial application, CADstream was developed to assist in the analysis, interventional guidance and reporting of breast MRI studies. CADstream can be integrated into any workflow scenario, and is compatible with all MRI scanners and PACS.

Confirma supports professional development in MRI and CAD technology through its extensive medical education program, including a newly launched continuing medical education (CME) program for breast MRI through the International Center for Postgraduate Medical Education (ICPME).

Confirma has established partnerships with companies including GE Healthcare, Philips Medical Systems, Bayer HealthCare, Medipattern, Vital Images and Carestream Health. Confirma has partnered with hundreds of imaging centers and corporate partners worldwide since 2003, helping develop more standardized, high performance breast MRI programs that deliver premium patient care. Confirma Europe GmbH opened operations in Berlin to further develop the European market. Frost & Sullivan recently recognized Confirma with the 2006 Industry Innovation and Advancement Award for the U.S. CAD market. For more information, visit www.confirma.com or call 877-811-2356.

Medtronic and Weigao Announce Joint Venture in China

2007-12-18T12:10:00.000-08:00

Medtronic, Inc. (NYSE:MDT) (“Medtronic”) and Shandong Weigao Group Medical Polymer Company Limited (Hong Kong Stock Exchange: 8199) (“Weigao”) today announced that they have agreed to form a joint venture to market therapies in the spine and orthopedics sector and that Medtronic would acquire a 15% equity interest in Weigao.

The joint venture will market in China Medtronic’s spinal products and Weigao’s orthopedic products which include therapies for the hip, shoulder, spine and trauma. Under the joint venture agreement (“Joint Venture Agreement”), Medtronic will have a 51% interest in the joint venture and Weigao will have a 49% interest.

Medtronic will purchase a 15% equity interest in Weigao for approximately HK$1,726 million (US$221 million) through the purchase of 80,721,081 newly issued H Shares of Weigao that are listed on the Hong Kong stock Exchange at a purchase price of HK$11.138 per share and an equal number of Weigao’s unlisted ordinary shares from Weigao’s existing shareholders at a purchase price of HK$10.247 per share. In connection with the purchase of the shares, Medtronic will have the right to nominate two non executive directors to Weigao’s board of directors as long as Medtronic owns 3.75% of the H Shares.

Closing of the transaction is subject to various conditions, including approval of the Chinese regulators and Weigao’s shareholders.

“China is key to our global strategy as we continue to expand our geographic footprint,” said Bill Hawkins, Medtronic president and CEO. “Weigao has a broad orthopedic and trauma product line that compliments Medtronic’s offerings, but even more importantly, we feel we can generate synergies with their very strong presence and reputation in China. We view Weigao as an ideal strategic partner.”

Mr. Chen Xue Li, chairman of Weigao said, “We take great pride in forming a strategic alliance with Medtronic, the world’s leading medical technology company. The collaboration will further broaden our business and raise our R&D capability, leveraging our extensive customer network and quality production, paving the way for Weigao to be the leading medical device company in Asia. With our localized knowledge, we hope to play an important role in Medtronic’s China strategy bringing Medtronic’s products to benefit millions of patients in China.”

About Medtronic
Medtronic, Inc., (www.medtronic.com) headquartered in Minneapolis, is the world’s leading medical technology company, alleviating pain, restoring health and extending life for people with chronic disease. Its Internet address is.

About Weigao
Weigao (www.weigaogroup.com) based in the Shandong province of the People’s Republic of China, is the leading manufacturer in China of medical devices and single-use consumables including infusion sets, syringes, blood transfusion sets and blood bags as well as orthopedic, cardiovascular stent and blood purification products.

Three Phase III Trials Show Rivaroxaban Outperformed Enoxaparin in Preventing Venous Thromboembolism After Major Orthopedic Surgery

2007-12-16T08:14:00.000-08:00

Phase III clinical trial results released today underscore that rivaroxaban, the oral, once-daily, investigational anticoagulant, was significantly more effective than enoxaparin, the standard of care, in preventing venous thromboembolism (VTE) in patients undergoing total hip or knee replacement surgery. Rivaroxaban-treated patients consistently experienced lower rates of VTE events compared to enoxaparin-treated patients across three large studies as well as demonstrating a similar rate of major bleeding events. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare AG.

Data from the RECORD1 and RECORD2 studies, evaluating rivaroxaban in total hip replacement surgery, were presented at the 49th Annual Meeting of the American Society of Hematology. Additional data from the head-to-head RECORD3 study, which showed similar statistically significant results for rivaroxaban compared with enoxaparin in total knee replacement surgery, also were presented.

Studies presented include:

RECORD1 (n=4,541), which demonstrated a 70 percent relative risk reduction
(RRR) (p<0.001) in total VTE when compared with enoxaparin and an 88
percent RRR (p<0.001) in major VTE

RECORD2 (n=2,509), which demonstrated a 79 percent RRR (p<0.001) in
total VTE when compared with enoxaparin, again with an 88 percent RRR
(p<0.001) in major VTE

RECORD3 (n=2,531), which demonstrated a 49 percent RRR (p<0.001) in
total VTE when compared with enoxaparin, and a 62 percent RRR (p=0.016) in
major VTE

Major bleeding rates were similar for both drugs (less than or equal to 0.6
percent) and differences were not statistically significant

No routine blood monitoring was required in the Phase III RECORD program at
the 10mg dose, based on the Phase II data and pharmacokinetic profile

"In RECORD1, 2 and 3 we have three Phase III trials showing unprecedented results in major orthopedic surgery for the prevention of VTE, and this is genuinely exciting," said Dr. A.G.G. Turpie, Principal Investigator in the RECORD program, Professor of Medicine, McMaster University, Canada. "In three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation in orthopedic surgery."

A key secondary endpoint of the study measuring the reduction of symptomatic VTE, also showed clinically meaningful results in favor of rivaroxaban. For this endpoint, the trials showed an RRR of 45 percent (p=0.222) in RECORD1, an 80 percent RRR (p=0.004) in RECORD2 and a 66 percent RRR (p=0.005) in RECORD3, compared to the standard regimen.

"The symptomatic VTE findings in the RECORD trials are extraordinary," added Dr. Turpie. "Previous trials were successful in identifying trends towards reducing symptomatic VTE, but with RECORD2 and 3 we are seeing clinically relevant reductions in symptomatic VTE for the first time in orthopedic surgery. These results are a major milestone in the evolution of anticoagulation therapy."

Rivaroxaban is a novel, oral, once-daily direct Factor Xa inhibitor in advanced clinical development for a range of patients who could benefit from prevention and/or treatment of blood clots. Rivaroxaban works at a pivotal stage in the coagulation process to directly inhibit the enzyme Factor Xa.

Detailed Study Results

Data presented at the ASH meeting are from RECORD (Regulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE), a global program of four pivotal trials involving more than 12,000 patients comparing oral, once-daily rivaroxaban, with subcutaneous enoxaparin in the prevention of VTE after elective, major orthopedic surgery. Following are summary results from RECORD1, RECORD2 and RECORD3:

RECORD1 (Abstract #6)

The RECORD1 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total hip replacement surgery. The duration of thromboprophylaxis in both treatments was five weeks. The study met its primary endpoint, and demonstrated a 70 percent RRR (p<0.001) in total VTE (composite of deep vein thrombosis, non-fatal pulmonary embolism and all-cause mortality), for patients treated with rivaroxaban compared with those treated with enoxaparin (1.1 percent and 3.7 percent, respectively). In addition, against the secondary endpoint, an 88 percent RRR (p<0.001) in major VTE (composite of proximal deep vein thrombosis, non-fatal pulmonary embolism and VTE-related death) was observed in patients treated with rivaroxaban (0.2 percent and 2.0 percent, respectively). Rivaroxaban also demonstrated a similar rate of major bleeding to enoxaparin (0.3 percent and 0.1 percent, respectively, p=0.178).

RECORD2 (Abstract #307)

The RECORD2 study evaluated the safety and efficacy of rivaroxaban compared with enoxaparin and placebo. The duration of thromboprophylaxis in patients undergoing total hip replacement was 35+/- 4 days (extended prophylaxis) for rivaroxaban or 10-14 days for those receiving enoxaparin, followed by placebo. The primary and secondary endpoints were the same as for RECORD1 with a 79 percent RRR (p<0.001) in total VTE and an 88 percent RRR (p<0.001) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated a similar rate of major bleeding compared to enoxaparin (0.1 percent and 0.1 percent, respectively, p=0.980), despite the greater treatment duration with rivaroxaban in this study.

RECORD3 (Abstract #308)

The RECORD3 trial compared the safety and efficacy of rivaroxaban with enoxaparin in patients undergoing total knee replacement surgery. Enoxaparin was initiated 12 hours before surgery, and rivaroxaban was initiated 6-8 hours after surgery; both treatments were continued for 10-14 days. Primary and secondary endpoints were the same as for RECORD1 and there was a 49 percent RRR (p<0.001) in total VTE and a 62 percent RRR (p=0.016) in major VTE for patients treated with rivaroxaban compared with those treated with enoxaparin. Rivaroxaban demonstrated similar rates of major bleeding to enoxaparin (0.6 percent and 0.5 percent, respectively, p=0.774).

Copies of the abstracts may be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm

Unmet Needs in Venous Thromboembolism (VTE)

VTE, a disease process that begins with a blood clot in a vein, includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). Patients undergoing major orthopedic surgery are at risk for VTE because, during the surgery the large veins of the leg that carry blood back to the heart can be damaged, significantly increasing the risk of coagulation and thrombosis.

Each year approximately 700,000 people elect to have hip and knee replacement surgeries in the U.S. and a blood clot is the most common cause of re-hospitalization for this patient group. In fact, VTE is considered the most frequent preventable serious and potentially fatal complication following major orthopedic surgery. But the threat stretches beyond orthopedic surgeries. Blood clots are one of the leading causes of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for acute myocardial infarction (heart attack); those undergoing major orthopedic surgery; and acutely medically ill patients.

About Rivaroxaban

To date, rivaroxaban is the most studied oral, direct Factor Xa inhibitor in clinical development. More than 20,000 patients have been evaluated in the completed Phase II programs and enrolled thus far in the Phase III programs. Almost 50,000 patients are expected to be evaluated in the total clinical development program.

Bayer HealthCare submitted a regulatory filing to the European Agency for the Evaluation of Medicinal Products (EMEA) at the end of October 2007 for approval to market rivaroxaban in the EU for the prevention of VTE in patients undergoing major orthopedic surgery of the lower limbs. Upon regulatory approval, rivaroxaban will be commercialized in Europe by Bayer Schering Pharma. A filing for rivaroxaban for a similar indication in the U.S. is planned in 2008, where upon approval, it will be will commercialized by Scios Inc. and Ortho-McNeil, Inc., both of which are wholly-owned subsidiaries of Johnson & Johnson.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of health care products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

GSK via its Centre Of Excellence for External Drug Discovery, exercises its options to further develop Exelixis’ anti-cancer C-Met inhibitior XL880

2007-12-16T08:09:00.000-08:00

Exelixis, Inc. (Nasdaq: EXEL) today announced that GlaxoSmithKline (GSK) has exercised its option to exclusively license XL880 for further development and commercialisation. XL880 is a small molecule compound currently being evaluated in phase 2 trials in patients with papillary renal cell carcinoma (PRC), gastric cancer and head and neck cancer. Under the terms of the collaboration between Exelixis and GSK initiated in October 2002 and amended in January 2005, GSK’s selection of XL880 entitles Exelixis to a selection milestone of $35 million and additional payments upon the attainment of specific development and commercialisation milestones. The $35 million selection milestone will be applied to repayment of an advance that GSK paid to Exelixis in 2005. Exelixis is also entitled to receive double-digit royalties on product sales if the compound is approved for marketing and commercialised. Exelixis will have certain co-promotion rights to XL880 in North America.

“XL880 is the first MET inhibitor to be evaluated in phase 2 trials, and the clinical data generated to date for this compound has been very compelling,” said George A. Scangos, Ph.D., President and Chief Executive Officer of Exelixis. “We believe that XL880 has substantial potential as a first-in-class therapy, and GSK and Exelixis look forward to the completion of the ongoing XL880 phase 2 trials and evaluation of pivotal trial options. We are pleased that GSK shares our belief in the significant clinical and commercial potential of this compound. Additionally, we believe that GSK’s selection of XL880 validates our strategy of building a franchise in the area of MET inhibition to exploit the potential of this promising target.”

“The exercise of the XL880 option confirms GSK’s growing status as a world leader in the development of new oncology medicines for use in thetreatment, prevention and supportive care of cancer patients,” commented Paolo Paoletti, MD, Senior Vice President of the Oncology Medicines Development Centre at GSK. “It further strengthens our oncology pipeline and demonstrates our commitment to identifying compounds that have the potential to deliver real benefit to patients. The data we have seen from trials conducted by Exelixis have given us confidence in the potential of XL880 for treating diseases for which there is high unmet medical need.”

The collaboration between Exelixis and GSK, which is managed by GSK’s Centre of Excellence for External Drug Discovery (CEEDD), covers seven compounds and their back-up and follow-up compounds currently in the Exelixis development pipeline. Under the terms of the collaboration, Exelixis submits the covered compounds to GSK as they achieve clinical proof-of-concept, which is a pre-determined measure of efficacy, generally based on phase 2 trial data, and GSK has the option to select two compounds, and potentially a third compound, for further clinical development and commercialisation. However, in the case of XL880, GSK requested in August 2007 to review the compound’s data prior to achievement of proof-of-concept. Exelixis agreed to the request and submitted the XL880 data package to GSK in September 2007.

Interim data from an ongoing phase 2 trial of XL880 in patients with PRC were presented in October 2007 at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Investigators reported at the conference that 15 of 19 patients (79%) with measurable disease evaluable for tumor response at the time of the data presentation had a decrease in tumour size (4-33%), including one patient with a partial response per RECIST criteria. All 19 evaluable patients with at least one post-baseline tumour assessment were reported to have had stable disease for at least three months, including 12 patients with stable disease for 6 to 15+ months. In 16 patients evaluable for safety at the time of the data presentation, the majority (72%) of adverse events (AEs) related to XL880 were Grade 1, 21% were Grade 2, and 5% were Grade 3 or higher. The Grade 3 AEs were hypertension in three patients. No Grade 4 or 5 AEs related to XL880 treatment were reported by investigators. A total of 15 serious adverse events (SAEs) in seven patients were reported, of which three were considered related to XL880 (two events of vomiting in one patient and hypertension in another patient).

Data from a phase 1 study of XL880 in patients with advanced solid tumours also were presented at the AACR-NCI-EORTC International Conference. Consistent with data previously reported from the phase 1 study, XL880 was reported to be generally well tolerated when given once daily over a 28-day cycle. Ten of 22 patients showed stable disease for at least three months. In a preliminary analysis of plasma samples from 21 patients, statistically significant changes in pharmacodynamic biomarkers were detected in the phase 1 clinical trial consistent with effects reported with other anti-angiogenic agents. This finding is also consistent with the hypertension that has been observed in patients receiving XL880.

Dr. Scangos noted, “We believe the selection of XL880 is a significant event that reflects the maturation of our pipeline and our discovery and development capabilities. XL880 represents one of many potentially significant compounds in our pipeline that we hope will help people with cancer. We believe that GSK’s selection of this novel compound will expedite the development of XL880 and may provide us with additional resources to advance our other compounds into and through clinical development.”

The effectiveness of GSK’s election to develop and commercialise XL880 and the associated technology transfer by Exelixis to GSK are subject to antitrust clearance, which is expected to occur in the first quarter of 2008.

About XL880

XL880 has attractive pharmaceutical properties, with high solubility and oral bioavailability. In preclinical studies, XL880 potently inhibited both MET and VEGFR with nanomolar potency, and retained potent activity against mutationally activated forms of MET found in hereditary papillary renal cell carcinomas. The compound also demonstrated dose-dependent tumor growth inhibition in models of breast cancer, colorectal cancer, non-small cell lung cancer, and glioblastoma, and has been shown to cause substantial tumor regression in all models tested. Significantly, a single dose of XL880 completely inhibited tumor growth for 21 days in a glioblastoma model. Three phase 2 trials of XL880 are ongoing in patients with PRC, gastric cancer and head and neck cancer.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at www.gsk.com.

GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK’s “bench to bedside” approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is developing a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.

About the GSK CEEDD

GlaxoSmithKline is enhancing the way it discovers and develops drugs by creating a small, dedicated team that will feed the GSK pipeline solely through the efforts of its external alliances. The CEEDD (Centre of Excellence for External Drug Discovery) was formed as further validation of GSK’s strategy to create small, independent and accountable R&D teams (known as Centres of Excellence for Drug Discovery or CEDDs). In essence, the CEEDD is virtualising a portion of the GSK pipeline; namely from target to clinical proof-of-concept, by forming multiple risk-sharing/reward sharing alliances. Capitalising on the speed and efficiency of its collaborators will allow GSK to deliver pharmaceutical products faster to patients. For more information, visit the CEEDD at www.ceedd.com.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis' broad product pipeline includes investigational compounds in phase 2 and phase 1 clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Daiichi-Sankyo. For more information, please visit the company's web site at http://www.exelixis.com.

FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR (lovastatin) 20 mg

2007-12-16T08:07:00.000-08:00

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's (FDA) joint panel of the Nonprescription Drugs Advisory Committee (NDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted against recommending approval at this time of the over-the-counter (OTC) use of MEVACOR® (lovastatin) 20 mg to help lower LDL cholesterol which may prevent a first heart attack.

"We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription MEVACOR 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider," said Edwin L. Hemwall, PhD, vice president, Global OTC Regulatory and Scientific Affairs.

The FDA is not bound by the committee's recommendation, but takes its advice into consideration. The anticipated action date by the FDA is Jan. 26, 2008.

About Prescription MEVACOR
MEVACOR is a prescription medicine that is approved in the U.S. for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularization procedures in healthy men and women with average or moderately elevated cholesterol levels.

Important Safety Information
According to the prescribing information, MEVACOR should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant. It is recommended that liver function tests be performed in all patients prior to daily use of MEVACOR 40 mg or more.

Muscle pain or weakness in patients taking prescription MEVACOR should be reported to a doctor because these could be signs of a serious side effect. Patients should tell their doctors about other medications they are taking in order to avoid possible drug interactions.

The most common adverse events reported with MEVACOR 20 mg taken once daily were diarrhea, flatulence, headache and myalgia.

Further information about MEVACOR is available on www.merck.com.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit http://www.merck.com.

Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights Into Heart Rhythms

2007-12-12T12:00:00.000-08:00

Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) clearance of the Reveal® DX and Reveal® XT, new Insertable Cardiac Monitors (ICMs) that offer unique diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The new Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal® and Reveal Plus® Insertable Loop Recorders. The Reveal DX will be commercially available in the United States beginning next week; the Reveal XT will follow.

The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

“The Reveal DX showcases Medtronic’s commitment to providing answers to patients with previously unidentified arrhythmias,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. “These patients often have their lives and activities curtailed because of unexplained fainting episodes. The Reveal monitors provide diagnostics and monitoring that can offer physicians a view into their patients’ conditions even when they’re not present.”

Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken. The device weighs just 15 grams and is approximately the size of a memory stick; unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads (tiny wires) that extend from the device into the heart’s chamber(s). To store an electrocardiogram (ECG) at the time of an episode, a patient places a hand-held, pager-sized activator over the device, and presses a button. Later a physician analyzes the stored information and determines if the episode was caused by an abnormal heart rhythm.

¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Arrhythmias
Arrhythmias are simply irregular heart rhythms in the heart’s atria (upper chambers) or ventricles (lower chambers). They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

About Medtronic
Medtronic, Inc. (www.medtronic.com ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic Receives FDA Marketing Clearance for Complete SE Biliary Stent System

2007-11-15T12:38:00.000-08:00

Medtronic, Inc. (NYSE: MDT), announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration for the Complete SE (self-expanding) Biliary Stent System, which is indicated for use in the palliative treatment of malignant neoplasms in the biliary tree – cancerous tumors in the bile duct that can compromise digestion by restricting the flow of digestive fluids.

U.S. commercial sales of the new biliary stent will begin immediately in a wide size range, with diameters of 4 – 10 mm and lengths of 20 – 150 mm.

Bench testing has shown the Complete SE Biliary Stent System to be extremely accurate in terms of stent placement. Accurate stent placement can decrease the likelihood that additional stents are necessary to cover the entire narrowing of the bile duct.

The safety and effectiveness of this device in the vascular system have not been established.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Invitrogen and CytRx Subsidiary RXi Pharmaceuticals Collaborate to Enhance RNAi Technologies for Therapeutic Applications

2007-11-14T10:09:00.000-08:00

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, and CytRx Corporation's (NASDAQ:CYTR) majority-owned subsidiary RXi Pharmaceuticals Corporation (RXi) today announced that they have entered into an agreement whereby RXi will exclusively license second generation RNA interference (RNAi) technology from Invitrogen for designated target genes in all human therapeutic categories.

Invitrogen's patent applications that are part of this agreement cover Stealth™ and other proprietary technologies related to enhanced configurations of chemically modified double-stranded RNA. Terms of the agreement were not disclosed.

“Licensing this broad technology from Invitrogen is part of our strategy to continually enhance our proprietary rxRNA™ compounds for therapeutic applications,” said Dr. Tod Woolf, President and Chief Executive Officer of RXi.

“Currently Invitrogen Stealth™ RNAi synthetic duplexes are widely used for RNAi research across both in vitro and in vivo applications due to their specificity, efficacy and stability,“ said Amy Butler, Invitrogen vice president of gene expression profiling.“We see the use of our Stealth™ RNAi technology in therapeutics as a natural next step in Invitrogen's efforts to be at the cutting edge of in vivo gene regulation.“

About Invitrogen

Invitrogen Corporation provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,700 scientists and other professionals and had revenues of approximately $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of high-value human therapeutics. The Company owns three clinical-stage compounds based on its small molecule "molecular chaperone" co-induction technology. In September 2006, CytRx announced that arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa clinical trial in patients with ALS. The Company plans to enter a Phase IIb clinical trial with arimoclomol in ALS in 2007, subject to U.S. Food and Drug Administration (FDA) clearance. The FDA has granted Fast Track designation and Orphan Drug status to arimoclomol for the treatment of ALS, which has also been granted orphan medicinal product status for the treatment of ALS by the European Commission. The Company has announced plans to commence a Phase II clinical trial for arimoclomol in stroke recovery in the first half of 2008, subject to FDA clearance. The Company has also announced plans to commence a Phase II clinical trial with its next drug candidate, iroxanadine, for diabetic foot ulcers in the first half of 2008, subject to FDA clearance. CytRx has recently opened a research and development facility in San Diego. For more information on the Company, visit www.cytrx.com.

About RXi Pharmaceuticals Corporation

RXi a discovery-stage biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi) for the treatment of human diseases. RXi's initial focus is on the treatment of neurological diseases, metabolic diseases and cancer. RXi has secured exclusive and non-exclusive licenses under certain issued and pending patents and patent applications covering therapeutic targets, chemistry and configurations of RNAi and delivery of RNAi within the body. The Company was founded by RNAi pioneers Craig Mello, Ph.D., 2006 Nobel Laureate for co-discovering RNAi and co-inventing RNAi therapeutics; Tariq M. Rana, Ph.D., inventor of fundamental technology for stabilizing RNAi and of RNAi nanotransporters; Greg Hannon, Ph.D., discoverer of short hairpin RNAi (shRNA); and Michael Czech, Ph.D., a leader in the application of RNAi to diabetes and obesity. RXi's CEO, Tod Woolf, Ph.D., previously co-invented and commercialized STEALTH™ RNAi, one of the most widely used second-generation RNAi research products. The Company currently operates as a privately held subsidiary of CytRx Corporation (NASDAQ: CYTR) and is located in Worcester, MA.

New Phase III Trial Results for Rivaroxaban to be Presented at the 49th Annual Meeting of the American Society of Hematology

2007-11-12T11:41:00.000-08:00

Findings from three phase III clinical trials of rivaroxaban will be presented in the plenary session and during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia, from December 8 to 11, 2007. Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. and Bayer HealthCare, AG.

The studies evaluated rivaroxaban in head-to-head comparison with enoxaparin, the current standard of care, for the prevention of venous thromboembolism (VTE) in patients undergoing major orthopaedic surgery. The presentations will highlight results from the recently-completed RECORD1 (Regulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) and RECORD2 studies in total hip replacement surgery as well as additional data from the RECORD3 trial, which evaluated rivaroxaban in total knee replacement surgery. Copies of the following abstracts can be viewed online at the ASH website: www.hematology.org/meetings/abstracts.cfm.

Oral Rivaroxaban Compared with Subcutaneous Enoxaparin for Extended Thromboprophylaxis after Total Hip Arthroplasty: The RECORD1 Trial Abstract# 6. Plenary presentation: Sunday, Dec. 9, 3:10 p.m., Hall A1, Georgia World Congress Center
Extended Thromboprophylaxis with Rivaroxaban Compared with Short-Term Thromboprophylaxis with Enoxaparin After Total Hip Arthroplasty: The RECORD2 Trial
Abstract# 307. Oral presentation: Monday, Dec. 10, 11:00 a.m., Rooms B312-B313a

Rivaroxaban – an Oral, Direct Factor Xa Inhibitor – for Thromboprophylaxis After Total Knee Arthroplasty: The RECORD3 Trial
Abstract# 308. Oral presentation: Monday, Dec. 10, 11:15 a.m., Rooms B312-B313a

Four additional abstracts will be presented as poster presentations on Saturday, December 8 and Sunday, December 9, 2007.

Johnson & Johnson Pharmaceutical Research and Development

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), is part of Johnson & Johnson, the world's most broadly based producer of healthcare products. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. J&JPRD is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Nexavar Becomes First and Only Approved Treatment of Hepatocellular Carcinoma in Europe

2007-10-30T12:28:00.000-07:00

Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first and only approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Additional regulatory filings in HCC are under review in countries around the world including the U.S. and, most recently, in Japan. Nexavar is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer.
“The approval of Nexavar, a novel multi-kinase inhibitor, represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options,” said Arthur J. Higgins, chairman of the Executive Committee of Bayer HealthCare. “This milestone will likely establish Nexavar as the standard of care in HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible. Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease.”

“Liver cancer is one of the few cancers in which the number of related deaths continues to increase,” said Hollings C. Renton, chairman, president and chief executive officer of Onyx Pharmaceuticals, Inc. “This second approval for Nexavar – first in advanced kidney cancer and now, less than two years later, in HCC – demonstrates our commitment to expediting the clinical development of this innovative therapy to treat today’s unmet needs in cancer. We will move swiftly to make Nexavar rapidly available to patients.”

The European Commission’s decision to approve Nexavar is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. The primary objective of the study was to compare overall survival in patients administered Nexavar versus those administered placebo. Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months in those taking placebo. There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for Nexavar was granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August. Most recently, the regulatory filing in Japan has been submitted.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. Over 600,000 cases of liver cancer are diagnosed worldwide each year (about 54,000 in Europe, 19,000 in the U.S. and 390,000 in China, Korea and Japan) and incidence is increasing. Currently, the 5-year survival rate for patients with liver cancer in Europe is less than 8 percent. The 5-year survival rate for liver cancer patients in the United States is 11 percent and less than 10 percent in Asia among patients with non-resectable tumors.

Nexavar’s Differentiated Mechanism
Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrated that Raf/MEK/ERK has a role in HCC. Therefore, blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in more than 50 countries, including the United States and the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar is approved for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Nexavar is also being evaluated by the companies, international study groups, government agencies, and individual investigators as a single agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, breast cancer and non-small cell lung cancer (NSCLC).

About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing innovative therapies that target the molecular mechanisms that cause cancer. The company is developing Nexavar, a small molecule drug, with Bayer HealthCare. For more information about Onyx’s pipeline and activities, visit the company’s web site at: www.onyxpharm.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

Medtronic Trials Confirm Ability of Interceptor Coronary Filter System and Export® Aspiration Catheter to Reduce Major Cardiac Events

2007-10-23T13:16:00.000-07:00

Reflecting its commitment to patient safety and ongoing medical research, Medtronic, Inc. (NYSE: MDT), today announced the findings from two clinical trials highlighting the ability of next-generation technologies to improve patient outcomes following interventional procedures. Results of the AMEthyst and EXPORT trials were presented this week at the 19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The AMEthyst trial was an 800-patient, U.S.-based multicenter, randomized trial to evaluate the safety and efficacy of the Interceptor PLUS Coronary Filter System as an adjunct to percutaneous interventions on saphenous vein bypass grafts (SVGs). The findings demonstrate that when compared to commercially available control devices (Medtronic’s Guardwire® Temporary Occlusion Balloon and Boston Scientific’s Filterwire EZ™), Medtronic’s new Interceptor PLUS Coronary Filter System works equally well in reducing major adverse cardiac events (MACE).

Medtronic also announced new findings from the EXPORT trial, a study assessing the safety and efficacy of the Export Aspiration Catheter, a device designed to remove thrombus and embolic material that is present in many blood vessel lesions and may become dislodged during interventional procedures. The study, a randomized, controlled trial of 250 patients at 24 sites in Europe and India comparing the use of Export prior to stent implantation with conventional stenting in patients with acute myocardial infarction (AMI), demonstrated the effectiveness of the Export Aspiration Catheter in improving blood flow in AMI patients.

Interceptor PLUS
A significant number of U.S. patients undergo coronary artery bypass grafting (CABG) procedures each year. The improved blood flow gives patients a new lease on life but, unfortunately, approximately half of these grafts can also become blocked or diseased over time. Moreover, they can become blocked by fragile, brittle and “friable” atheromous material as they age. When this occurs, cardiologists perform stent angioplasty to keep blood flowing through the vein grafts – a process that can also release showers of embolic debris. Embolic debris, if not contained, can flow downstream to result in blockages of tiny tributary vessels and trigger “microinfarcts,” or tiny heart attacks that destroy areas of heart muscle.

The Medtronic Interceptor PLUS Coronary Filter addresses this problem through its unique design. A braided nitinol filter mounted on a 0.014” hypotube, Interceptor PLUS is delivered in a closed state into the artery, moved past the blockage and opened before performing conventional stent angioplasty. The Interceptor PLUS Coronary Filter maintains blood flow in saphenous vein grafts while trapping the embolic debris.

Data from the AMEthyst trial showed that Interceptor PLUS met the primary study endpoint to demonstrate safety, MACE at 30 days, indicating non-inferiority of Interceptor PLUS compared to control devices. Interceptor PLUS also demonstrated efficacy with device success over 90 percent and a low incidence of clinical failure when compared to commercially available control devices. Medtronic’s successful completion of this study enables the company to pursue 510(k) clearance with the FDA to market the device in the U.S.

Export XT
Cleared for use in the U.S. in 2006, the Export XT Aspiration Catheter design allows for superior deliverability in even the most demanding cases. The full-wall variable braiding design helps eliminate segment joints and weak points in the catheter to improve kink resistance, and allows enhanced deliverability due to seamless transition of shaft stiffness from one end of the catheter to the other. The device features a soft tip material with a short, beveled design for minimal vessel trauma and improved debris capture, plus a hydrophilic coating for greater lubricity. Since its introduction in 2001, the Export Aspiration Catheter product line has been used to remove embolic debris in more than 200,000 patients worldwide.

Data from the EXPORT trial found Export met its primary endpoint. In patients presenting with an AMI, primary aspiration using the Export Aspiration Catheter is associated with a higher percentage of patients with ST segment resolution of greater than 50 percent at 60 minutes post procedure and/or a myocardial blush grade III immediately post-procedure than in patients with conventional stenting. In addition, primary aspiration using the Export catheter is associated with a lower rate of no-flow, higher corrected TIMI frame count post procedure, and a lower requirement for bail-out techniques.

“These trials demonstrate the Medtronic commitment to innovate new technologies that are specifically designed to reduce the risks associated with interventional procedures,” said Sean Salmon, vice president and general manager of the Coronary and Peripheral business at Medtronic. “The performance of these new devices is well characterized and represents a significant advance in interventional cardiology.”

About Medtronic
Medtronic, Inc. (http://www.medtronic.com/ ), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

New Long-Term Data Suggest Clinical Differences in Safety and Efficacy Between CYPHER Sirolimus-Eluting Coronary Stent and Taxus Stent

2007-10-23T13:14:00.000-07:00

An analysis of fifteen-month data from the Western Denmark Heart Registry found that patients who received the CYPHER® Sirolimus-eluting Coronary Stent had a lower risk of blood clots (stent thrombosis) and were less likely to need another procedure at the same lesion site (target lesion revascularization) than patients who received a Taxus Stent. The study is being shown at the Transcatheter Cardiovascular Therapeutics 2007 meeting (TCT 2007).

The differences between the CYPHER® Stent and the Taxus Stent in terms of definite stent thrombosis, definite/probable/possible stent thrombosis and target lesion revascularization were statistically significant and favorable for the CYPHER® Stent. Patients who received the Taxus Stent were 55 percent more likely to develop definite stent thrombosis than patients who received the CYPHER® Stent [confidence interval (CI) 0.21-0.94]. Taxus Stent patients were also 49 percent more likely to develop definite/probable/possible stent thrombosis than patients who received a CYPHER® Stent (CI 0.30-0.87). In addition, the CYPHER® Stent performed considerably better than the Taxus Stent in terms of target lesion revascularization, as Taxus Stent patients were 32 percent more likely to need a repeat procedure compared with patients who received the CYPHER® Stent (CI 0.52-0.90).

"The study data show that the clinical outcomes following drug-eluting stent implantation may depend on the type of stent used to treat a patient with coronary artery disease," said Professor Leif Thuesen, MD, DMSci, from Aarhus University Hospital in Denmark.

"The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in real-world settings," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "These findings are consistent with the results of other studies recently published in peer-reviewed medical journals [i.e. Stettler et al. Lancet 2007;370:937-48, Schömig et al. J Am Coll Cardiol 2007;50:1373-80, and Daemen et al. Lancet 2007;369:667-78] and build on the growing body of evidence indicating that the CYPHER® Stent and the Taxus Stent should be evaluated separately."

The Western Denmark Heart Registry is a multi-center, prospective, observational registry of all patients in western Denmark who receive coronary angiograms or coronary interventions, including percutaneous interventions and bypass surgery. This analysis evaluated patients from the registry who received a drug-eluting stent – either the CYPHER® Stent or Taxus Stent – from January 2002 through June 2005. Patients who received a combination of drug-eluting and bare metal stents (BMS) were excluded. All patients were followed for 15 months.

The primary endpoints of the study were stent thrombosis, myocardial infarction and death. No significant differences were found in the clinical outcomes of myocardial infarction or death.

Stent thrombosis was defined according to the Academic Research Consortium (ARC) definitions for thrombosis: definite, which required confirmation of a clot by angiogram at follow-up; probable, which included a heart attack in the treated vessel in patients who did not have an angiographic confirmation of a thrombosis; and possible, which included sudden unexplained death.

About the CYPHER®Stent

The CYPHER® Stent is the most studied drug-eluting stent in history and has been chosen by cardiologists worldwide to treat more than three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.

The CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of a sirolimus-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT™ Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.

For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.

About Cordis Corporation

Cordis, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease.

Vanda Pharmaceuticals Hires Chief Commercial Officer Al Gianchetti

2007-10-23T13:06:00.000-07:00

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced that Al Gianchetti will join the Company as Senior Vice President and Chief Commercial Officer effective October 25, 2007. Mr. Gianchetti joins Vanda with more than 18 years of experience in commercial roles at GlaxoSmithKline. Most recently, he held the position of Vice President, Global Commercial Strategy, where he was responsible for the global launches of Levitra(R) and Avodart(R). Prior to this role he was a Regional Vice President in the largest U.S. sales region within GSK. Before this, he launched Avandia(R), and Augmentin ES(R), two blockbuster products.

"We are very pleased to have Al join the Vanda Team," said Mihales Polymeropoulos, M.D., President and CEO of Vanda. "His depth of industry experience and proven track record across a wide spectrum of therapeutic areas are pivotal to the commercial success of Vanda's late stage pipeline."

About Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Inc. is a biopharmaceutical company with a particular focus on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. In addition to iloperidone, Vanda is developing VEC-162, a compound for the treatment of sleep and mood disorders which is currently in Phase III for sleep disorders. Vanda's third product candidate in clinical development, VSF-173, is currently in a Phase II trial for the treatment of excessive sleepiness. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com/.

Invitrogen and HUPO Announce New Standard for Mass Spectrometry

2007-10-11T11:09:00.000-07:00

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, in collaboration with the Human Proteome Organization (HUPO), an international scientific organization that promotes proteomics, announced the launch of the HUPO Gold Mass Spectrometry (MS) Protein Standard sampling program. This will become the first commercially available all-recombinant human protein standard for mass spectrometry.

The HUPO Gold MS Protein Standard, which is a defined mixture of known human proteins designed to allow scientists to benchmark the quality of their experimental data and compare results from experiment to experiment, is expected to become an essential tool in data validation for all mass spectrometry-related analysis. This standard should allow scientists to validate and cross-reference their data, independent of sample types processed, mass spectrometry workflows performed, or actual mass spectrometers used.

"With a variety of published mass spectrometry workflows, as well as the large number of instruments and data-analysis software packages available for use, researchers today face major challenges validating and comparing their published data," said John Bergeron, Chair of HUPO Scientific Initiatives. "The HUPO Gold MS Protein Standard together with HUPO directed training should lead to field-generated data of greater run-to-run accuracy and reproducibility."

"Currently available standards for mass spectrometry are isolated directly from human samples, so they potentially contain naturally occurring contaminants, as well as proteins subject to natural genetic variations leading to slight changes in protein mass which can contribute to reduced reliability and reproducibility of a standard," said Paul Predki, Invitrogen Vice President of Research and Development. "By developing this new standard using recombinant methods, we have designed a valuable resource that will aid scientists in making their substrate identification more definitive and will allow them to reference their efforts on a global research scale."

Samples of the HUPO Gold MS Protein Standard are immediately available to members of HUPO. The entire HUPO Gold MS Protein Standard will be commercially available in the first quarter of 2008.

For more information please visit www.invitrogen.com/hupogold.

About Invitrogen

Invitrogen Corporation (NASDAQ:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About HUPO

HUPO (www.hupo.org) was launched on February 9, 2001. On that date, a global advisory council was officially formed that included leading international experts in the field of proteomics from the academic, government and commercial sectors. HUPO's council currently has 48 members from 19 countries, all of whom are renowned proteomics researchers from the academic and industrial sectors. HUPO's headquarters have been located at the McGill University and Genome Quebec Innovation Centre in Montreal, since January 2005. HUPO now has 2000 founding members from 69 countries.

HUPO promotes the development and awareness of proteomics research and advocates on behalf of proteomics researchers throughout the world. It has benefited from substantial contributions of time and energy from members of HUPO's council, research institutions and pharmaceutical companies around the globe.

Genetic Immunity Closes $2 Million Dollar Bridge Financing

2007-10-10T12:11:00.001-07:00

Genetic Immunity LLC, a clinical stage biopharmaceutical company and a leader in the development of DNA based nanoparticle immunotherapies, announced today the completion of a $2 million dollar bridge financing.

Genetic Immunity's lead product is DermaVir Patch developed for the treatment of HIV/AIDS. The Company believes that this biopharmaceutical product will reconstitute HIV-specific immunity and reduce the viral load set-point in HIV-infected individuals enabling them to manage the disease safely prior to the initiation of the currently approved drug regimes. DermaVir Patch applies the Company's patented platform technology to efficiently deliver the nanoparticle medicine topically (needle free) to dendritic cells for transport to the draining lymph nodes where T cells are educated to kill the virus. The product has been demonstrated as safe and effective in reducing viral loads in monkey studies. A Phase I clinical trial has demonstrated safety and immunogenicity of DermaVir Patch in HIV-infected individuals. NIH and Karolinska Institute sponsored Phase II trials are ongoing in the U.S. and Sweden.

The Company also announced the engagement of the New York based investment firm of Rodman & Renshaw, LLC as its financial advisor.

"We are pleased to have secured the bridge financing which will enable the Company to launch an additional Phase II trial to demonstrate the proof of concept of DermaVir Patch in reducing the viral load in HIV positive individuals," said Dr. Julianna Lisziewicz, President and CEO of Genetic Immunity. "We are also very excited to be working with such a well regarded and respected firm as Rodman & Renshaw to assist the Company to develop the financial strategies for completing our clinical trials and bringing DermaVir Patch to the market."

About Genetic Immunity

Genetic Immunity is a U.S. - Hungarian clinical stage biopharmaceutical company focusing on the development and commercialization of its patented immunotherapeutic platform technology which addresses unmet medical needs for chronic diseases such as HIV/AIDS and allergies. Since its founding in 1998, the Company has pursued its goal of being the first company to bring an in vivo immunotherapeutic product to the market to treat one of the world's deadliest disease - HIV/AIDS. The Company intends to be the leader in developing immunotherapies for the burgeoning industry of molecular medicine.

About Rodman & Renshaw

Rodman & Renshaw is a full service investment bank dedicated to providing investment banking services to companies that have significant recurring capital needs due to their growth and development strategies, along with research and sales and trading services to institutional investor clients that focus on such companies. Through its AcumenBioFin(TM) division, Rodman is a leading investment banking firm to the biotechnology sector, a capital intensive market segment, as well as a leader in the PIPE (private investment in public equity) and RD (registered direct placements) transaction markets.

Invitrogen and Natural Selection Team to Bring New MicroRNA Sequences to Researchers

2007-10-02T06:18:00.000-07:00

Invitrogen Corporation (NASDAQ:IVGN), a provider of essential life science technologies for research, production and diagnostics, announced today it has entered into a licensing agreement with Natural Selection, Inc. to make new microRNA sequences available to researchers. This agreement enables Invitrogen to provide the most comprehensive human and mouse microRNA arrays on the market.

The microRNA sequences have been verified experimentally using deep sequencing, array profiling, and qRT-PCR methods. Invitrogen is the first company to commercialize microRNA content discovered using these new deep sequencing technologies. The agreement will lead to a significant increase in human and mouse microRNA content on the market and available to researchers. The microRNA sequences will be submitted to the on-line database of The Sanger Institute, a leading biomedical research charity. Its on-line database, recently updated to 10.0 version, is the world repository for microRNA sequences.

"For the first time, scientists will be able to investigate the role of many novel and previously unknown microRNAs using Invitrogen's microRNA arrays with Natural Selection content," said Amy Butler, Invitrogen Vice President of Gene Expression Profiling. "By combining these new sequences with the latest Sanger 10.0 content, we are greatly expanding the potential for discovery of novel microRNA biomarkers for disease and development."

Also as part of the agreement, Invitrogen will make available a larger set of computationally-predicted microRNA sequences over the next few years for human and mouse resulting from a proprietary design algorithm developed by Natural Selection, Inc. under funding from the National Science Foundation.

"These new tools will significantly enhance the research community's understanding of the role of small RNAs in biological processes," said Dr. Gary Fogel, Vice President of Natural Selection. "This advance is particularly important in the areas of cancer and stem cell research, where microRNAs have been found to play a critical role. We are very pleased to team with Invitrogen to make these sequences available to the research community."

For more information on Invitrogen products for microRNA profiling, visit www.invitrogen.com/ncode. The Sanger microRNA database is located at http://microrna.sanger.ac.uk/sequences/.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About Natural Selection, Inc.

Natural Selection, Inc. (NSI) is a private firm specializing in the application of computational intelligence methods for problem solving in medicine and biochemistry, such as image analysis, pharmaceutical design, structure prediction, sequence analysis, and personalized medicine. NSI also supports a variety of defense and industry applications. Founded in 1993 by Dr. Lawrence J. Fogel, a pioneer of evolutionary computation, NSI is headquartered in San Diego, California. For more information, visit www.natural-selection.com

GSK applies for licence to market OTC weight loss product In Europe

2007-10-02T06:15:00.000-07:00

GlaxoSmithKline (GSK) today announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA).

Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie, low-fat dietand went on sale there in June 2007 under the brand name alli™. Alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over-the-counter product to be combined with a comprehensive support programme.

John Clarke, President GSK Consumer Healthcare said: “This is a significant milestone and an important opportunity for GSK. Obesity is a rapidly increasing problem and a significant burden for healthcare systems in Europeand elsewhere. Leveraging our considerable expertise in OTC switches, we hope to offer consumers a new, clinically-proven option which can help to tackle this problem.

“So far, alli is performing well in the US and, if our application is successful, we will commit to rolling out a similar responsible marketing campaign with the same level of support for consumers in Europeas we have done in the US. We want to see people achieving gradual, sustained weight loss by using alli in tandem with a healthy eating, low-fat diet and increased exercise. We’ve said all along that this is no magic pill. If people are looking for a quick fix, this is not it but it is a powerful motivator, helping people lose up to 50% more weight than with diet alone*.”

If the regulatory process is successful, GSK would be granted a licence to market non-prescription orlistat 60mg in all 27 EU member countries, although initial launch markets have not been confirmed.

*- Anderson JW, Schwartz SM, Hauptman J et al. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Ann Pharmacother 2006; 40: 1717-23

- Study BM14149 and study NM14161. GSK data on file.

About Orlistat

§ Orlistat is the most comprehensively studied weight loss medication to date. Its safety and efficacy are well documented and have been established through data from more than 100 clinical studies involving more than 30,000 patients.

One of these studies – for Xenical®** - was the four-year landmark XENDOS trial conducted by Roche, its inventor and manufacturer. In this study alone, over 3,000 people were followed for four years while taking Orlistat, and it isthe longest completed study conducted to date for a weight-loss medicine. In all, since the launch of the 120 mg dose of orlistat as the prescription drug Xenical™ in 1999, there have been more than 28 million patient treatments with orlistat in more that 145 countries worldwide.

§ GlaxoSmithKline completed an agreement with Roche in February 2007 that enables the company to seek regulatory approval for the first non-prescription weight loss medicine in countries outside of the US excluding Japan.

The overweight and obese population in Europe

§ The prevalence of obesity has risen by between 10-50% in the majority of European countries in the last 10 years (International Obesity Taskforce (http://www.iotf.org )

§ Currently almost 400 million adults in Europe are estimated to be overweight and about 130 million to be obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf )

§ The average BMI in Europe is nearly 26.5 and overweight affects 25-75% of the adults in Europe. A BMI of 25 and above is overweight and 30 and above is obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf

• Obesity and overweight increase the risk of type 2 diabetes, cardiovascular disease, certain cancers, and gallbladder disease, resulting in a decreased quality of life and an increased risk of premature death (WHO 2003; Fact sheet: Obesity and overweight www.who.int/hpr/NPH/docs/gs_obesity.pdf

**Xenical® is a registered trademark of the Roche Group

About GSK

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media

GE and Lilly Announce Research Collaboration to Co-Develop Molecular In Vitro Diagnostics for Cancer Treatments

2007-10-01T09:03:00.000-07:00

GE Global Research, the General Electric Company’s (NYSE:GE) centralized research and development organization, and GE Healthcare today announced a three-year collaborative research agreement with Eli Lilly and Company (NYSE:LLY) to discover and develop advanced in vitro diagnostic assays that may predict cancer treatment response to targeted therapies.

In addition to Lilly’s existing chemotherapy agents, Lilly is developing targeted cancer therapeutics, which are now in both early and late stage clinical development. GE is developing advanced multiplexed tissue-based assays and image analysis tools that can measure multiple biological pathways. The goal of this collaboration is to discover key protein and gene signatures that will predict the likelihood that a medication will be effective in treating certain cancers. Once identified the signatures can then be used to pre-select patients who are good candidates for the targeted therapy.

“The co-development of diagnostics and therapeutics is a major strategy of GE Healthcare’s “Early Health” vision, and our collaboration with Lilly and our expansion into in vitro diagnostics is right in line with this strategy,“ said, Dr. Michael Montalto, head of Molecular Imaging and Diagnostics Advanced Technologies for Global Research. “The combination of diagnostics and therapeutics is opening new doors in the fight against cancer and other life-threatening diseases. Through the application of molecular and cell biology to understanding disease, we can provide pharmaceutical companies with more advanced tools to develop more optimal drug therapies for cancer patients.”

“Our collaboration with GE complements Lilly’s research and development strategy of tailored therapeutics, or in other words, finding the right dose of the right medication at the right time for patients. Through our collaboration with GE Healthcare and GE Global Research, we hope to identify biomarkers for two of our targeted cancer therapeutic agents by examining patient tissues in order to determine which patients are most likely to respond to the medications and just as importantly which are not,” said Dr. Richard Gaynor, M.D., vice president, cancer research and global oncology platform for Eli Lilly and Company.

As the world becomes more educated and advanced in molecular medicine, the healthcare industry is experiencing a growing convergence of therapeutics and diagnostics. Through the use of molecular diagnostic tools that can discover key protein or gene signatures, pharmaceutical companies can begin to use that information to determine which patients are most likely to respond to a particular medication based on their particular genetic makeup.

The agreement between GE and Lilly will provide GE with access to clinical tissue samples from unidentified patients enrolled in Lilly’s clinical trials. In turn, Lilly will have access to GE’s advanced technologies in automated tissue-based image analysis and molecular reagents. These tools can be used during drug development to aid Lilly in evaluating the effectiveness of their drug candidates and potentially select patients for future trials.

In addition to helping Lilly identify patients for future trials, the diagnostic tools GE is providing also have the potential to greatly reduce the time and cost of cancer drug development.

The collaboration with Lilly is consistent with GE Healthcare’s Early Health Vision, which is about transforming healthcare delivery from a focus on treating late disease to a focus on adopting an Early Health model of care – where prevention, pre-disease detection, and early diagnosis are the key drivers. GE Healthcare has a strong portfolio of in vivo diagnostic imaging technologies and molecular contrast agents to assist with the detection and diagnosis of cancer, and expanding this strength toward in vitro diagnostics is a natural extension of this strategy.

About GE Global Research

GE Global Research is one of the world's most diversified industrial research organizations, providing innovative technology for all of GE’s businesses. Global Research has been the cornerstone of GE technology for more than 100 years, and is now focused on developing breakthrough innovations in areas such as molecular medicine, alternative energy, nanotechnology, advanced propulsion, and security technologies. GE Global Research is headquartered in Niskayuna, N.Y. and has facilities in Bangalore, India; Shanghai, China; and Munich, Germany. Visit Global Research at www.ge.com/research.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Headquartered in the United Kingdom, GE Healthcare is a US$17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

Medtronic and Kyphon Announce Clearance from German Federal Cartel Office for the Merger of Medtronic and Kyphon

2007-09-19T10:20:00.000-07:00

Medtronic, Inc. (NYSE: MDT) and Kyphon Inc. (Nasdaq: KYPH) announced today that the German Federal Cartel Office has given its clearance in connection with the previously announced merger agreement between Kyphon and Medtronic, Inc. Completion of the transaction, which is expected later this year or in the first quarter of 2008, remains subject to obtaining approvals of antitrust authorities in several other jurisdictions, the approval of Kyphon’s stockholders and other customary closing conditions. A special meeting of Kyphon’s stockholders to vote on the proposed merger has been called for October 16, 2007. If further antitrust clearances are obtained prior to the Kyphon stockholders' meeting, the companies will provide an update at the time of the meeting.

ABOUT MEDTRONIC
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Medtronic is a registered trademark of Medtronic, Inc.

ABOUT KYPHON
Kyphon develops and markets medical devices designed to restore and preserve spinal function and diagnose the source of low back pain using minimally invasive technologies. The company’s products are used in balloon kyphoplasty for the treatment of spinal compression fractures caused by osteoporosis or cancer, in the Functional Anaesthetic Discography™ (F.A.D.™) procedure for diagnosing the source of low back pain, and in the Interspinous Process Decompression (IPD®) procedure for treating the symptoms of lumbar spinal stenosis. More information about the company and its products can be found at http://www.kyphon.com/ and its balloon kyphoplasty patient education Web site, http://www.spinalfracture.com/.

Kyphon and IPD are registered trademarks, and Functional Anaesthetic Discography and F.A.D. are trademarks, of Kyphon Inc.

Bayer launches mobile website for cellphones and blackberries

2007-09-04T07:01:00.000-07:00

Bayer AG has set up a new source of information for its latest corporate news. Users of mobile terminals – such as cellphones, blackberries, PDAs, palmtops and smartphones – can now call up the most important Bayer news items, press releases and the latest Bayer share prices as well as general information on the Leverkusen-based chemical and pharmaceutical group. The website is aimed at media representatives, analysts and anyone else who may be interested in the company, who regularly goes online via a mobile terminal and who wants to obtain the latest information about Bayer both quickly and conveniently. Within its industry, Bayer is the first company in Germany to offer a mobile-enabled website and to follow the trend towards a greater use of flat rates, so that cellphone users can surf the internet wherever they are, without restrictions and at a fixed rate.

The corporate website has been specially optimized for this application and can be called up in German and English. Users can access, among other things, corporate facts and figures, products, KPIs, stock information and charts as well as Bayer sports news. In addition, the investor relations and press pages carry the relevant contact details for queries.

Device recognition allows the identification of over 4,000 different mobile terminals. Depending on the device class, all web pages have been set up for the required display, so that graphics, text and navigation elements are specially tailored for the device that is in use.

“In our mobile information society the internet increasingly accompanies its users while traveling – a need which is clearly met by this special corporate website for mobiles, blackberries etc. It is possible to call up corporate news and share prices at any time, virtually anywhere. So Bayer is now providing perfect pocket-sized convenience,” says Heiner Springer, Head of Communications at Bayer AG.

The website is available in German at:
http://mobil.bayer.de and http://www.mobil.bayer.de

The website is available in English at:
http://mobile.bayer.com and http://www.mobile.bayer.com

For more information visit www.bayer.de

U.S. FDA Approves GE Healthcare’s Newest Mobile Mammography System for Improved Access to Breast Care

2007-08-22T11:11:00.000-07:00

GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced that it has received U.S. Food and Drug Administration (FDA) approval for its new mobile mammography product that will improve access to breast cancer screening for millions of women around the world. The mobile Senographe® Essential is built on the company’s Senographe Essential platform, the next-generation of GE’s proven Senographe Full Field Digital Mammography systems.

As medical organizations continue to offer full-field digital mammography in a mobile setting, GE Healthcare’s newest mobile unit will feature the largest digital detector in the mammography market, advanced ergonomic design for the technologist, optimized patient comfort and seamless workflow connectivity. The foundation of the Senographe Essential imaging excellence is GE’s advanced digital detector, which delivers the industry's highest Detective Quantum Efficiency (DQE) - the standard for quantifying digital X-ray image quality - at low doses.

“GE’s goal is to enhance breast care for women worldwide and bring this technology to those who otherwise would not have access to it,” said David Caumartin, general manager of Global Mammography for GE Healthcare. “GE offers customers the broadest portfolio when it comes to breast imaging and the new mobile Essential will be the top of the line mobile product in the market featuring all the proven advantages of our Senographe platform.”

First Mobile Essential in Seattle

A study published in May 2007 by the National Cancer Institute found that use of mammography screening had dropped four percent from 2000 to 2005. In 2005, only 70 percent of women surveyed for the study reported getting an annual mammogram. During the same timeframe, among women 50-64, the group most at risk for breast cancer, screening was down 7 percent, from 79 percent to 72 percent.

According to the American Cancer Society, mammography rates in Washington state are also below the national average. In a 2005-2006 study, only 56.3 percent of women 40-64, who are most at risk for breast cancer, were screened. The national average was 60.5 percent. To combat the low numbers and to improve the overall health of women in the area, Connie Lehman, M.D., Ph.D., director of radiology at the Seattle Cancer Care Alliance and professor and vice chair of radiology, section head of breast imaging, at the University of Washington School of Medicine, will take an active approach toward improving breast cancer screening rates.

Courtesy of a month-long fundraising campaign sponsored by the Seattle Division of Safeway Inc. and supported by its employees and customers along with a corporate grant from the Safeway Foundation to acquire a van for the mobile Essential unit, Lehman will be able to hold breast-screening clinics at locations around the Seattle region. Eventually Lehman will be scheduling visits to cities throughout western Washington.

“Women living in the state of Washington have higher rates of breast cancer compared to the rest of the country,” said Lehman. “And yet, compared to the rest of the country, we also have fewer women receiving regular screening mammography. We have an opportunity with this program to provide more women the opportunity to be screened with the latest technology for early detection of breast cancer. This is our way of removing some of the barriers preventing women from having screening mammograms. We are delighted to partner with GE and Safeway to make a difference for women and their families in our community.”

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

GE Healthcare and Sprint Deliver Enhanced Wireless Connectivity to Hospitals Across North America

2007-08-14T07:02:00.000-07:00

Uninterrupted communication within a hospital is a requirement for physicians, patients and visitors and is essential to quality care. Sprint (NYSE: S) and GE Healthcare announced today their collaboration to provide in-building wireless communications services to hospitals in North America. Patients, clinicians and hospital visitors will benefit from secure, reliable voice and data communications, supporting an environment conducive to higher levels of patient care.

Historically, the use of mobile phones in hospitals has been limited due to unreliable wireless support and the risk of interference between wireless phones and medical equipment. Using the new combined offering, physicians and caregivers will be able to communicate amongst each other and securely access patient information from almost anywhere in the facility.

The new in-building cellular communications network from GE Healthcare and Sprint’s Custom Network Solution (CNS) team leverages GE’s CARESCAPE™ Enterprise Access™, a single, universal wireless platform powered by MobileAccess, and includes Sprint handsets. This solution will provide hospitals with a comprehensive platform for voice and data communications over secure cellular, Wi-Fi and telemetry infrastructure that requires only one installation. Using the combined offering, clinicians, patients and hospital visitors can communicate more efficiently and with ease.

“Sprint CNS provides scalable coverage and a high-capacity platform for wireless voice and data services on the Sprint National Network and Nextel National Network, enhancing the mobility and productivity of staff at hospitals and other businesses,” says Darlene Braunschweig, vice president of CNS at Sprint. “We are very excited to partner with GE Healthcare to provide differentiated and innovative mobile solutions that are critical for every business. This new solution facilitates constant communication of secure information amongst hospital staff; an aspect very critical to patient care.”

GE CARESCAPE Enterprise Access, built on the MobileAccess technology platform, enables critical patient data to be securely coordinated, managed and distributed without the type of communications failures, interference or interruptions that can be caused by un-integrated systems. It is designed to transparently incorporate new systems and services without the need to install parallel, standalone infrastructures. CARESCAPE Enterprise Access is part of GE Healthcare’s CARESCAPE portfolio, an integrated suite of patient monitoring devices, communications networks and IT systems designed to transform traditional patient monitoring data into clinical intelligence. The CARESCAPE portfolio, released in May 2007, reflects a new approach to patient monitoring that provides clinicians with the opportunity to act earlier in the care process when compared to traditional patient monitoring and communication methods.

“The CARESCAPE portfolio represents our commitment to providing customers with a wide range of products and services that work together to help clinicians improve patient care,” said Munesh Makhija, General Manager of Systems and Wireless for GE Healthcare’s Monitoring Solutions business. “Our agreement with Sprint reflects this commitment. By harnessing the power of in-building cellular communications, hospitals will be able to offer secure, reliable voice and data communications throughout a campus, which can support improved communication and ultimately, patient outcomes.”

ABOUT GE HEALTHCARE

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

ABOUT SPRINT NEXTEL

Sprint CNS is a leader in providing enhanced in-building and campus-wide network consulting, integration and fixed mobile convergence solutions. Sprint designs, deploys and maintains wireless networks and mobility solutions that deliver the productivity and efficiency of voice and data communications to virtually anywhere a business and their employees need them. Sprint’s CNS team offers 24/7 technical support and manages all stages of the customer deployment process, from the initial requirements assessment through installation and deployment with consultant-grade methods, procedures and tools. For more information about Sprint CNS, please visit www.sprint.com/cns.

Sprint Nextel offers a comprehensive range of wireless and wireline communications services bringing the freedom of mobility to consumers, businesses and government users. Sprint Nextel is widely recognized for developing, engineering and deploying innovative technologies, including two robust wireless networks serving 54 million customers at the end of the second quarter 2007; industry-leading mobile data services; instant national and international walkie-talkie capabilities; and a global Tier 1 Internet backbone. For more information, visit www.sprint.com.

Invitrogen Launches Breakthrough Media for Human Embryonic Stem Cells

2007-08-14T06:59:00.000-07:00

Invitrogen, a provider of essential life science technologies for research, production and diagnostics, and Novocell Inc., a stem cell engineering company, today announced the launch of a new fully-defined, serum- and feeder-free media specifically formulated for the growth and expansion of human embryonic stem cells (hESCs). The product, known as STEMPRO(R) hESC SFM, will be sold by Invitrogen under a licensing agreement with Novocell.
STEMPRO(R) hESC SFM is the first serum- and feeder-free media for hESCs that has been shown to maintain these cells in a genetically normal state. Unlike other defined media, which have been tested only in one or two hESC lines, STEMPRO(R) hESC SFM has been extensively tested and proven to keep the cells pluripotent in a number of lines, including BG01, BG02, BG03, HUES9, H1 and H9. Pluripotency, the ability of hESCs to develop into cells of all three major lineages in the body, is a key characteristic of embryonic stem cells, and one reason they hold such promise for therapeutic uses.

Currently, researchers working with hESCs grow them in serum-containing undefined media using mouse or human embryonic fibroblast feeder cells. These culture methods not only make it difficult to keep cells pluripotent, they are also labor-intensive and lead to challenges in scaling up cell production. Also, the undefined nature of these cultures means scientists have a harder time controlling culture conditions and comparing results from experiment to experiment.

"STEMPRO(R) hESC SFM represents a major breakthrough in the field of embryonic stem cell research," said Joydeep Goswami, Vice President, Stem Cells and Regenerative Medicine. "Researchers today face major challenges when culturing hESCs, including difficulties in maintaining pluripotency, lack of definition in current culture systems and consistency in their experiments. This revolutionary product addresses these challenges and allows for more ideal cell culture conditions to keep hESCs genetically normal and in an undifferentiated state."

"We are pleased to collaborate with Invitrogen in bringing our defined media for hESCs to market," said Alan Lewis, Ph.D., President and CEO of Novocell. "We anticipate this product will accelerate the important work of stem cell research. The commercialization of our defined media is especially motivating for Novocell as we continue to advance and develop our cell therapy for diabetes."

Invitrogen is the premier supplier of tools and reagents for stem cell research. The company offers more than 1,200 products tailored to various parts of the stem cell research workflow for embryonic and adult stem cell populations, including Dynabeads(R) for cell separation; pre-conjugated stem cell antibodies from Molecular Probes; and gold standard media from GIBCO such as KNOCKOUT(TM) Serum Replacement and MesenPRO(TM) RS reduced serum medium for mesenchymal stem cells. The company recently announced the launch of the BG01v/hOG engineered stem cell line, which allows scientists to monitor the pluripotency of hESCs without sacrificing those cells, and the STEMPRO(R) EZPassage(TM) tool for stem cell passaging.

About Invitrogen

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California, and conducts business in more than 70 countries around the world. The company is celebrating 20 years of accelerating scientific discovery. Invitrogen globally employs approximately 4,300 scientists and other professionals and had revenues of more than $1.15 billion in 2006. For more information, visit www.invitrogen.com.

About Novocell

Novocell Inc. is a stem cell engineering company with research operations in San Diego, CA, and Athens, GA, dedicated to creating, delivering, and commercializing cell and drug therapies for diabetes and other chronic diseases. Novocell is the first company to efficiently engineer human embryonic stem cells into definitive endoderm, the gatekeeper cells that differentiate into many other cells and tissues of the endoderm lineage. Novocell has three primary technologies: stem cell engineering, cell encapsulation, and drug discovery. The company was founded in 1999, merged with CyThera and BresaGen in 2004 and completed a $25M Series C financing in July 2007. For more information, visit www.novocell.com.

WuXi PharmaTech Celebrates IPO on NYSE

2007-08-09T13:14:00.001-07:00

WuXi PharmaTech, a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today opened for trading on the New York Stock Exchange under the ticker symbol “WX” after its successful IPO in which it raised $185 million.

E-House (China ) Holdings Ltd., a leading provider of real estate services in China , yesterday opened for trading on the New York Stock Exchange under the ticker symbol “EJ” after its successful IPO raised $201 million.

"With the additions of Wuxi PharmaTech and E-House to our growing family of world-class listed companies, the New York Stock Exchange is now privileged to list 40 companies from Greater China," said NYSE Euronext John A. Thain. "We welcome the opportunity to offer Wuxi PharmaTech and E-House access to the U.S. capital marketplace and the world's largest pool of investors, and are committed to growing our partnership with the people and business community of China . NYSE Euronext also looks forward to providing these outstanding companies and their shareholders with the superior service, market quality and brand visibility that come with listing on NYSE Euronext markets."

The combined global market capitalization of the 40 NYSE-listed companies from Greater China listed on the NYSE is $1 trillion (July 31, 2007 ). The NYSE roster of companies from Greater China includes 28 from Mainland China , 7 from Hong Kong and 5 from Taiwan .

To celebrate today’s special occasion, WuXi PharmaTech Chairman and CEO Ge Li, joined by company executives and NYSE Euronext CEO John A. Thain, rang the opening bell.

View listed companies from Mainland China.
View listed companies from Hong Kong.
View listed companies from Taiwan.

About WuXi PharmaTech (NYSE: WX)

Founded in 2000, Shanghai-based WuXi PharmaTech is the leading China-based pharmaceutical and biotechnology R&D outsourcing company. As a research-driven and customer-focused company, WuXi PharmaTech provides pharmaceutical and biotechnology companies a broad and integrated portfolio of laboratory and manufacturing services throughout the drug discovery and development process. WuXi PharmaTech’s services are designed to assist its global partners in shortening the cycle and lowering the cost of drug discovery and development by providing cost-effective and efficient outsourcing solutions that save its customers both time and money. Its operations are grouped into two segments: laboratory services, consisting of discovery chemistry, service biology, analytical, pharmaceutical development and process development services, and manufacturing, focusing on manufacturing of advanced intermediates and active pharmaceutical ingredients for R&D use. In 2006, WuXi PharmaTech provided services to 70 pharmaceutical and biotechnology customers, including nine of the top 10 pharmaceutical companies in the world, as measured by 2006 total revenues.

About E-House (NYSE: EJ)

E-House (China ) Holdings Limited (“E-House”) is a leading real estate services company in China based on scope of services, brand recognition and geographical presence. Since its inception in 2000, E-House has experienced rapid growth and has become the largest real estate agency and consulting services company in China . E-House provides primary real estate agency services, secondary real estate brokerage services and real estate consulting and information services, and has received numerous awards and accolades for its innovation and quality, including “China ’s Best Company” from the National Association of Real Estate Brokerage and Appraisal Companies in 2006. E-House believes it has the largest and most comprehensive real estate database system in China , providing up-to-date and in-depth information covering residential and commercial real estate properties in all major regions in China .

About NYSE Euronext (NYSE: NYX)

NYSE Euronext, a holding company created by the combination of NYSE Group, Inc. and Euronext N.V., commenced trading on April 4, 2007 . NYSE Euronext (NYSE Euronext: NYX) operates the world’s largest and most liquid exchange group and offers the most diverse array of financial products and services. NYSE Euronext, which brings together six cash equities exchanges in five countries and six derivatives exchanges in six countries, is a world leader for listings, trading in cash equities, equity and interest rate derivatives, bonds and the distribution of market data. Representing a combined €21.7/$29.6 trillion total market capitalization of listed companies and average daily trading value of approximately €85/$115 billion (as of April 30, 2007), NYSE Euronext seeks to provide the highest standards of market quality and integrity, innovative products and services to investors, issuers, and all users of its markets.

GSK receives decision from FDA on Advair 500/50 for COPD

2007-08-08T10:38:00.002-07:00

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has issued a not approvable letter for the supplemental drug application for the 500/50 strength of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in the treatment of patients with chronic obstructive pulmonary disease (COPD).

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations. GSK will be meeting with FDA to discuss this request in more detail and determine next steps, including discussion of data GSK has recently generated on the reduction of exacerbations with the Advair 250/50 strength.

“We are very surprised and disappointed by this FDA decision particularly given the outcome of the FDA advisory committee meeting earlier this year,” said Katharine Knobil, M.D., Vice-President of Respiratory Clinical Development for COPD at GSK. “The advisory committee voted unanimously that Advair 500/50 demonstrated a significant reduction in the risk of exacerbations. We believe in the strength of the data; this application is based on the results of the largest COPD study conducted in more than 6,000 patients over three years. We are committed to working with the FDA to address any questions they have and to pursue a way forward.”

About Advair in COPD

Advair 250/50 is currently indicated for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Advair does not replace fast-acting inhalers to treat sudden symptoms. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. Patients with COPD often have multiple risk factors for reduced bone mineral density. Advair Diskus may increase this risk, therefore, bone mineral density assessment is recommended prior to starting Advair Diskus and periodically thereafter. Long-term use of inhaled corticosteroids, including Advair Diskus, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered.

For more information about Advair please visit www.gsk-us.com

About GlaxoSmithKline

Advair was developed and is marketed by GlaxoSmithKline, a research based pharmaceutical company and a world leader in respiratory care. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information please visit www.gsk.com.

GSK gives consent under Canada’s Access to Medicines Regime for generic version of HIV/AIDS medicine for use in Rwanda

2007-08-08T10:38:00.001-07:00

As part of its broad commitment to improving access to medicines, GlaxoSmithKline today announced it has given consent through Canada’s Access to Medicines Regime to enable a Canadian company (Apotex) to manufacture a generic fixed dose combination (FDC) antiretroviral (ARV), containing two molecules over which GSK has patent rights (zidovudine and lamivudine) for the treatment of HIV/AIDS in Rwanda.

Canada’s Access to Medicines Regime reflects the WTO “31f” agreement of August 2003 and enables the government to authorise the production of certain patented medicines for export. The legislation includes controls which are designed to ensure that these essential medicines reach the patients for whom they are intended and the authorisation to be granted will be subject to these controls. GSK has agreed to waive royalties on the basis that Apotex’s triple combination generic ARV will be supplied on a no profit basis.

Paul Lucas, President and CEO, GSK Canadasaid, “Tackling the AIDS crisis is one of the greatest challenges the world faces. GSK continues to play its part to tackle this crisis through research and development, not-for-profit pricing and ongoing investment in dedicated community programmes. Our decision to allow Apotex to manufacture an FDC containing two GSK molecules is part of this broad commitment. It also shows that Canada’s Access to Medicines Regime operates effectively to enable supply of medicines from Canadaas envisaged under the 31f Agreement.”

About GlaxoSmithKline

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and health-care companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK has issued eight previously announced voluntary licences to produce generic versions of GSK’s patented HIV/AIDS medicines for patients across Sub-Saharan Africa. In 2006 alone, GSK supplied 86 million tablets of preferentially priced ARVs to developing countries, while over 120 million ARV generic tablets were supplied by companies licensed by GSK.

Survey Indicates Meniett Therapy Is Preferred Treatment, After Diet Modification, for Management of Meniere's Disease

2007-08-06T10:40:00.000-07:00

Results of a survey published in the August 2007 issue of Otology & Neurotology indicates that the Meniett® Low Pressure Pulse Generator manufactured by Medtronic, Inc. (NYSE: MDT) is the preferred treatment method after diet modification for patients diagnosed with Ménière's Disease in an only hearing ear. The survey was conducted among a nonrandom sample of clinically active members of the American Otological Society and the American Neurotology Society by researchers from the Division of Otolaryngology – Head and Neck Surgery at Penn State Milton S. Hershey Medical Center.

Dietary modification was recommended as first-line therapy by 99 percent of the survey respondents, including moderate to strict salt restriction, decreased caffeine intake and avoidance of alcohol. A diuretic was also recommended by 96 percent of respondents.

When asked what they would offer if initial treatment failed, respondents chose the Meniett® device first and most frequently over therapies such as intratympanic corticosteroids, endolymphatic sac mastoid shunt, intratympanic gentamicin perfusion and endolymphatic sac vein decompression.

“We agree that the Meniett® makes the most sense as the second-line treatment of choice for this difficult problem. It has demonstrative efficacy and a low-risk profile,” stated Jon Isaacson, M.D., associate professor of Surgery and director of Otology/Neurotology at Penn State Milton S. Hershey Medical Center and co-conductor of the survey.

Approximately 2.6 million people in the United States and Europe1 suffer from Ménière’s disease, a disorder associated with excess fluid in the inner ear. This complex disease is characterized by vertigo in combination with hearing loss, tinnitus (ringing in the ear) and pressure in the ear. The origin is unknown and there is no cure, which makes managing the disease difficult when symptoms are severe. Unpredictable vertigo attacks with nausea and vomiting can be very debilitating, with patients unable to work or perform routine activities.2

About the ENT Business at Medtronic

Located in Jacksonville, Fla., the ENT business at Medtronic (www.MedtronicENT.com) is a leading developer and manufacturer of products to treat diseases of the ear, nose and throat (ENT). Patients seeking additional information about Ménière’s disease and the Meniett device should visit www.meniett.com.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

1. Stahle J, Stahle C, Arenberg IK. The incidence of Ménière’s disease. Arch Otolaryngol Head Neck Surg. 1978;104:99-102.

2. Anderson JP and Harris JP. Impact of Ménière’s disease on quality of life. Otol Neurotol. 2001;22:888-894.

FDA issues second approvable letter for Trexima

2007-08-02T06:57:00.000-07:00

GlaxoSmithKline (LSE & NYSE: GSK) and POZEN Inc. (NASDAQ: POZN) today announced that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for Trexima™ (sumatriptan/naproxen sodium). An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S.marketing approval.

In January 2007, POZEN and GSK responded to the FDA’s first approvable letter, submitting additional safety data from clinical trials, data from GSK’s database, and additional in vitro preclinical data. In the second approvable letter, no additional information regarding the cardiovascular safety of Trexima was requested. The companies agreed to conduct a prospective study after approval to evaluate the effects on blood pressure during chronic, intermittent treatment.

The FDA has requested that POZEN further address the Agency’s concern, prior to approval, about the potential implications from one preclinical in vitro chromosomal aberration study (one of four standard genotoxicity assays) in which genotoxicity was seen for the combination of naproxen sodium and sumatriptan, but not with either component alone. None of the other three standard genotoxicity studies (Ames test, mouse lymphoma TK assay, in vivo mouse micronucleus assay) demonstrated any genotoxicity for the combination of naproxen sodium and sumatriptan.

The companies intend to request a meeting with the FDA as quickly as possible to discuss the necessary steps to address the Agency’s concerns.

Trexima was the proposed brand name for the product candidate combining sumatriptan 85 mg, as the succinate salt, formulated with RT Technology™ and naproxen sodium 500 mg in a single tablet. Several new names are under consideration at FDA, but pending a final decision on a new name the product will still be referred to as Trexima.

The FDA had previously determined that Trexima is effective as an acute treatment for migraine headaches. POZEN and GSK will continue to work with the FDA on revisions to the proposed package insert and the proposed trade name.

About Imitrex® (sumatriptan succinate) Tablets

Imitrexis a prescription medication indicated for the acute treatment of migraine in adults. Imitrex should only be used when a clear diagnosis of migraine has been established. Patients should not take Imitrex if they have certain types of heart disease, history of stroke or TIAs, peripheral vascular disease, Raynaud syndrome, or blood pressure that is uncontrolled. Patients with risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes or are a smoker, should be evaluated by a doctor before taking Imitrex. Very rarely, certain people, even some without heart disease, have had serious heart related problems. Patients who are pregnant, nursing, or taking medications should talk to their doctor.

About Naproxen sodium

Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is contained in Anaprox®, Anaprox DS®, Naprelan®, Aleve® and in a number of over-the-counter medications. Naproxen sodium is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendinitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea. Naproxen-containing products should not be used by patients who have had allergic reactions to any product containing naproxen, nor in patients in whom aspirin or other NSAIDs induce the syndrome of asthma, rhinitis, and nasal polyps. Patients who have a history of peptic ulcer or gastrointestinal bleeding, kidney problems, uncontrolled hypertension or heart failure should consult a physician before using naproxen-containing medications. NSAIDs may cause increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors for cardiovascular disease. Serious gastrointestinal toxicity such as bleeding, ulceration and perforation can occur at any time in patients treated chronically with NSAID therapy and physicians should remain alert for such effects even in the absence of previous GI tract symptoms. Patients who are pregnant or are nursing should consult a physician before use of a naproxen-containing medication.

About GlaxoSmithKline

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For detailed company information, see GlaxoSmithKline's website: www.gsk.com

Medtronic to Acquire Kyphon for $3.9 Billion

2007-07-27T07:17:00.000-07:00

Medtronic, Inc. (NYSE: MDT) and Kyphon (NASDAQ: KYPH) today announced that the companies have signed a definitive merger agreement under which Medtronic will acquire all of the outstanding shares of Kyphon for $71 per share in cash. The transaction, which was unanimously approved by the boards of directors of both companies, is valued at approximately $3.9 billion. This excludes $320 million in payments associated with the St. Francis Medical Technologies, Inc. and Disc-O-Tech Medical Technologies, Ltd. transactions.

The acquisition price represents a 32% premium over Kyphon’s closing stock price on July 26, 2007 of $53.68 and a 35% premium over Kyphon’s 30-day average trading price of $52.76 per share. The transaction, which is anticipated to close in the first calendar quarter of 2008, is expected to be neutral to Medtronic earnings in the first full fiscal year after closing and accretive thereafter. Medtronic expects the merger to yield significant revenue, cost and tax synergies.

“We expect our combination with Kyphon to help accelerate the growth of Medtronic’s existing spinal business by extending our product offerings into some of the fastest growing product segments and enabling us to provide physicians with a broader range of therapies for use at all stages of the care continuum,” said Art Collins, chairman and chief executive officer of Medtronic. “Importantly, the combination will also enable more patients of all ages to receive the benefits of modern, minimally invasive spinal treatments earlier in their care, with life-style friendly options that are simpler, faster and less invasive than many traditional surgical treatments.

“We have great respect for Rich Mott and his team and look forward to Kyphon’s employees joining Medtronic at the close of the transaction. Kyphon’s world-class, global sales force will play a central role in the continued development of our spinal business,” Collins concluded.

“We are very enthusiastic about the opportunity to deliver outstanding value for our shareholders that fully reflects Kyphon’s innovation and growth potential. This merger also combines two recognized industry leaders in spinal treatments,” said Richard Mott, president and chief executive officer of Kyphon. “By merging our complementary strengths and collective resources into one organization, we will meaningfully increase our ability to ensure we meet the needs of our clinician customers around the world and the patients they serve. This combination also offers our employees the opportunity to become part of an organization with a shared vision and the depth of resources that are increasingly beneficial for sustained success in our industry. We look forward to working with Medtronic to complete the transaction quickly and seamlessly. Our board of directors believes that this acquisition is in the best interests of our shareholders, employees and other stakeholders and has unanimously voted to recommend that Kyphon shareholders vote in favor of it.”

The two companies’ product lines and geographic presence are highly complementary. While both companies have expertise in minimally invasive, highly effective treatments, Medtronic’s spinal surgery focus has been on providing treatment options for younger patients who are suffering from scoliosis and degenerative disc disease in the cervical and lumbar spine. Kyphon’s focus has been on treating older patients suffering from vertebral compression fractures and spinal stenosis. Together, the combined entity will be able to leverage its knowledge of modern fusion, dynamic stabilization, artificial disc replacement, biologics, vertebral augmentation, interspinous process decompression, disc disease diagnosis, navigation and minimally invasive techniques to serve patients with a broader variety of spinal disorders in order to alleviate pain and restore health for more patients.

The combined entity will also have a larger and expanded base of customers than Medtronic serves alone. Medtronic primarily serves orthopaedic and neurological surgeons who specialize in spinal surgery. Kyphon serves these same physicians and also has a significant customer base with interventional radiologists and interventional neuroradiologists.

The transaction will be financed by a combination of cash on the balance sheet and debt.

The transaction is subject to customary closing conditions, including approval by antitrust regulators as well as Kyphon shareholders.

Cleary Gottlieb Steen & Hamilton LLP is acting as legal advisor to Medtronic and Goldman, Sachs & Co. and Piper Jaffray are acting as financial advisors. Latham & Watkins LLP is acting as legal advisor to Kyphon and JPMorgan is acting as financial advisor.

Analyst Conference Call/Webcast
Medtronic and Kyphon will host an investor conference call (612-332-1210) later this morning at 7:30 a.m. central time (5:30 a.m. pacific time) to discuss the Kyphon acquisition. For complete instructions on how to participate in the conference call, or to listen to the live audio webcast or a replay of the webcast, please refer to the Investor Relations sections at http://www.medtronic.com or http://www.kyphon.com.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

ABOUT KYPHON INC.
Kyphon develops and markets medical devices designed to restore and preserve spinal function and diagnose the source of low back pain using minimally invasive technologies. The company’s products are used in balloon kyphoplasty for the treatment of spinal compression fractures caused by osteoporosis or cancer, in the Functional Anaesthetic Discography™ (F.A.D.™) procedure for diagnosing the source of low back pain, and in the Interspinous Process Decompression (IPD®) procedure for treating the symptoms of lumbar spinal stenosis. More information about the company and its products can be found at www.kyphon.com and its patient education Web site, www.spinalfracture.com.

GlaxoSmithKline statement in diabetes care study thiazolidinediones and heart failure: a teleo-analysis [1]

2007-07-27T07:15:00.000-07:00

This is an analysis of existing data that has been previously published (online in Diabetes Care, 29 May 2007) and provides no new information on the risk of heart failure associated with the thiazolinediones (TZD) class.

“The risk of heart failure in diabetes patients and with use of these medicines is well recognised and is clearly identified in prescribing information to doctors in the UK. Whilst continued patient safety is paramount, we must also remember that Type II diabetes can have devastating consequences including stroke, blindness, amputation and kidney failure. Rosiglitazone therefore has an important role to play as one of the medicines, doctors can use to treat the 2 million patients currently diagnosed with type 2 diabetes in the UK,” said, Dr. Alastair Benbow, European Medical Director, GlaxoSmithKline.

The analysis does not include the results from the ADOPT2 (A Diabetes Outcome Progression Trial) study, and the RECORD3 (Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of glycemia in Diabetes) interim analysis, two recently published long-term prospective studies in which the risk of heart failure is assessed in patients taking rosiglitazone.

The authors correctly point out that diabetic patients are known to be at increased risk of developing congestive heart failure. The authors also report an increased risk of heart failure with TZD therapy. It is well recognized that this class of medicine can cause fluid retention which may exacerbate or lead to heart failure. This is clearly stated in the European prescribing information for rosiglitazone. In addition, in Europe, rosiglitazone is contraindicated for patients with New York Heart Association (NYHA) Class I-IV cardiac failure or those with a history of cardiac failure. These contraindications have been in the SPC since rosiglitazone was approved in Europein June 2000.

Questions about the safety of rosiglitazone are best answered by long-term prospective studies such as ADOPT and RECORD interim analysis. In ADOPT the same number of congestive heart failure (CHF) serious adverse events were reported for rosiglitazone versus metformin in a drug naive diabetic population. However those on glibenclamide experienced a lower rate of serious CHF events compared to both rosiglitazone and metformin.

In the RECORD interim analysis, rosiglitazone was associated with significantly more cases of CHF when compared with patients on control – metformin and sulphonylurea (hazard ratio 2.24). Despite the increase in CHF however, the primary outcome of cardiovascular hospitalizations and death showed no significant difference between the rosiglitazone group and the met/SU group.

It is important for physicians to use rosiglitazone in appropriate patients in line with the European SPC, which states that rosiglitazone should not be used in patients with CHF. GSK is confident in the overall safety profile of rosiglitazone when used appropriately.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

References

1. Singh et. Al. Thiazolidinediones and Heart Failure: A Teleo-Analysis. Diabetes Care. Published online: 29 May, 2007. Print publication: 27 July 2007

2. Kahn S et al. Glycemic durability of rosiglitazone, metformin or glyburide monotherapy. NEJM 2006 355: 23; 2427-2443

3. Home P D, et al. Rosiglitazone Evaluated for Cardiovascular Outcomes – An Interim Analysis. NEJM 2007: 357: 28-38

Medtronic Announces Agreement with Spinal Neuromonitoring Innovator

2007-07-26T11:08:00.000-07:00

Medtronic, Inc. (NYSE: MDT) today announced it has entered into a distribution and development agreement with Axon Systems, a privately-held developer of neuromonitoring technology used during spinal surgery. The agreement will allow Medtronic and Axon Systems to bring to market the next generation of surgeon directed and professionally supported spinal neuromonitoring technology and expand the availability of this critical technology.

This agreement will have an immediate impact on Medtronic’s spinal neuromonitoring product line and sets the stage for possible integration across all of Medtronic's core spinal therapy offerings.

The first new products enabled by this strategic alliance will be the NIM-ECLIPSE™ Spinal System of neuromonitoring capital and disposable equipment. NIM-ECLIPSE received 510k clearance in the U.S. in May 2006. This equipment will allow for as many as 32 channels of simultaneous electroencephalography (EEG), evoked potentials (EP) and electromyography (EMG) monitoring. NIM-ECLIPSE™ Spinal System also provides for automatic pedicle screw monitoring with direct nerve and screw stimulation. During spinal surgery, the NIM-Eclipse may allow physicians to monitor critical neural pathways which helps prevent post-operative neurological deficits.

“We are extremely excited about our relationship with Axon Systems and the opportunity to improve the availability of intraoperative spinal neuromonitoring service and technology,” said Pete Wehrly, senior vice president and president of the Spinal and Biologics businesses at Medtronic. “Axon Systems has been a neuromonitoring technology innovator and leader since 1987 and our partnership will enable us to better integrate neuromonitoring technology into Medtronic’s core spinal therapies.”

“Working with Medtronic is a wonderful opportunity for us to improve our abilities of how best to deliver and integrate neuromonitoring technology and techniques into surgical procedures that place the spinal nervous system at risk,” said Howard Bailin, founder and COO of Axon Systems.

About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. Medtronic collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com/ and its patient-education Web sites, http://www.back.com/ , http://www.iscoliosis.com/ , http://www.maturespine.com/ and http://www.necksurgery.com/.

About Medtronic
Medtronic, Inc. (http://www.medtronic.com/), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

About Axon Systems
Axon Systems, founded in 1987, is a leading manufacturer of neurological intraoperative (NIOM) and intensive care monitors. Its products are used in operating rooms to monitor critical neural pathways during surgery, aiding surgeons and helping to prevent post-operative neurological deficits. In the intensive care unit Axon products are used for diagnostic long-term monitoring and to provide prognostic information and guiding patient care. More information about the company and its products can be found at http://www.axonsystems.com/

ISENTRESS (raltegravir), an Investigational Oral HIV Integrase Inhibitor, in Combination Therapy Demonstrated HIV RNA Reduction Comparable to Efaviren

2007-07-24T07:13:00.000-07:00

ISENTRESS™ (raltegravir), an Investigational Oral HIV Integrase Inhibitor, in Combination Therapy Demonstrated HIV RNA Reduction Comparable to Efavirenz in Treatment-Naïve HIV-Positive Patients

Results from an ongoing 48 week Phase II study of ISENTRESSTM (raltegravir), an investigational oral HIV integrase inhibitor, under development by Merck & Co., Inc., in combination with tenofovir (Viread®) and lamivudine (Epivir®) demonstrated that ISENTRESS provided reductions in HIV RNA to undetectable levels of less than 50 copies/mL (83 to 88 percent of patients) comparable to efavirenz (Sustiva®) combined with the same agents (87 percent of patients). These results were observed with all four doses of ISENTRESS studied (100 mg, 200 mg, 400 mg or 600 mg twice daily) in treatment-naïve (previously untreated) patients infected with HIV. In addition, ISENTRESS showed minimal impact on total and low-density lipoprotein (LDL) serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. These results indicate that ISENTRESS provided sustained viral load reduction and minimal lipid effects when compared with the initial 24-week results presented at the 2006 International AIDS Conference in Toronto.

These data were presented this week at the 4th International AIDS Society Conference (IAS) on HIV Pathogenesis, Treatment and Prevention in Sydney, Australia.

"In this study, the viral load reductions were sustained at Week 48 in treatment-naïve patients," said Martin Markowitz, MD, lead study investigator and clinical director of the Aaron Diamond AIDS Research Center in New York. "These findings are consistent with the efficacy and tolerability profiles that were seen with ISENTRESS at 24 weeks."

Study design
These findings are from an ongoing multi-center, dose-ranging double-blind, randomized trial of previously untreated HIV-positive patients. In this study, 198 treatment-naïve HIV-positive patients received either ISENTRESS (100mg, 200mg, 400mg, or 600 mg, each administered orally twice daily) in combination with tenofovir and lamivudine or received 600 mg efavirenz dosed orally once daily in combination with the same agents. The complete 48-week data being presented today compared ISENTRESS to efavirenz both in combination with tenofovir and lamivudine on three measures: sustained reductions in HIV viral RNA; improvements in CD4 cell counts from baseline; and evaluation of safety and tolerability.

Reduction in viral load
At 48 weeks of therapy, 83 to 88 percent of patients receiving the regimen containing ISENTRESS (at all doses studied) maintained reductions in HIV RNA viral load to less than 50 copies/mL. Results were comparable for patients taking the efavirenz combination, with 87 percent of patients maintaining reductions in HIV RNA viral load to less than 50 copies/mL at week 48.

At baseline, HIV RNA for patients on the ISENTRESS arm of the study was 58,206 copies/mL (100 mg; n=39), 64,715 copies/mL (200 mg; n=40), 43,083 copies/mL (400 mg; n=41) and 57,919 copies/mL (600 mg; n=40). Baseline HIV RNA for patients in the efavirenz arm of the study was 67,554 copies/mL (600 mg; n=38).

Increase in CD4 cell counts
Patients on both treatment regimens experienced increases in CD4 cell counts. Mean baseline CD4 cell counts ranged from 271 to 338 cells/uL across all treatment arms. At 48 weeks of treatment, the mean increase from baseline in CD4 cell counts of the groups receiving ISENTRESS ranged from 144 to 221 cells/uL, and mean increase from baseline in CD4 cell counts of the efavirenz group was 170 cells/uL.

Minimal effect on lipid levels
Both treatment regimens were generally well tolerated. ISENTRESS had minimal effect on total and LDL serum cholesterol, serum triglycerides and the ratio of total cholesterol to HDL cholesterol. The mean changes from baseline at Week 48 for ISENTRESS (all doses combined) and efavirenz, respectively, were -2.3 mg/dL and +20.7 mg/dL (p <.001) for total cholesterol; -7.5 mg/dL and +3.0 mg/dL (p=.0016) for LDL cholesterol; -1.0 mg/dL and +49.5 mg/dL (p=.068) for triglycerides and -0.59 mg/dL and -0.47 mg/dL (p=0.52) for the ratio of total cholesterol to HDL cholesterol.

Clinical safety profile
Clinical adverse experiences were generally mild to moderate, with nausea, dizziness and headache reported most frequently. Neuropsychiatric adverse events, such as abnormal dreams, depression, nightmare and suicidal thoughts were less frequent in patients on the ISENTRESS based regimens (all doses combined) compared to those on the efavirenz-based regimen, occurring respectively in 13 versus 29 percent, through week 48.

About ISENTRESS
ISENTRESS, previously referred to as MK-0518, is the first in a new class of investigational antiretroviral agents called integrase inhibitors that inhibit the insertion of HIV viral DNA into human DNA. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV replication process - protease and reverse transcriptase - but there are no approved drugs that inhibit integrase. ISENTRESS is being studied in a twice daily regimen as a single tablet administered without regard to food. ISENTRESS does not require boosting with ritonavir.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS for use in treatment-experienced patients and has granted priority review status, a designation for investigational products that address unmet medical needs. Under the priority review designation, the FDA is expected to review and act on the NDA for ISENTRESS within six months of submission. Merck anticipates FDA action by mid-October and as planned is also moving forward with regulatory filings in countries outside of the United States.

ISENTRESS expanded access program
Expanded access programs with ISENTRESS are currently open to HIV/AIDS patients with limited or no treatment options. Expanded access is a mechanism supported by many regulatory agencies for getting investigational treatment to patients who have a life threatening disease and who cannot be satisfactorily treated with an alternative therapy or available drug. Currently, more than 4,000 patients worldwide are participating in the expanded access programs with ISENTRESS. For more information on the program visit www.benchmrk.com

Prevalence of HIV/AIDS
An estimated 40 million people are infected with HIV/AIDS worldwide, and more than 4 million new infections occurred worldwide in 2006i. In 2005, over 1 million Americans were living with HIV and approximately 40,000 new cases of HIV/AIDS were diagnosed.ii AIDS is one of the top causes of infectious disease-related mortality worldwide, responsible for nearly 3 million deaths last year alone.iii

Merck HIV research
Merck is committed to developing innovative therapies that offer advances in the treatment of infectious diseases - including HIV. Merck's efforts to develop investigational treatments and a vaccine against HIV/AIDS have been under way for almost 20 years and continue today. Merck began its HIV integrase inhibitor research in 1993 and was the first to demonstrate inhibition of HIV integrase in vitro and in vivo.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

i UNAIDS, 2006 Report on the Global AIDS Epidemic
ii CDC. Basic Statistics. HIV/AIDS Surveillance Report: HIV Infection and AIDS in the United States and Dependent Areas, 2005.
iii UNAIDS and WHO. AIDS Epidemic Update. December 2006.

Genzyme Corporation Announces Phase 3 Trial of Mozobil in non-Hodgkin's Lymphoma Meets Primary Endpoint

2007-07-19T13:55:00.000-07:00

Genzyme Corp. (Nasdaq: GENZ) today announced that it has successfully completed its phase 3 trial of MozobilTM (plerixafor) in non-Hodgkin’s lymphoma (NHL), and that the trial has robustly met its primary and secondary endpoints.

The randomized, double-blind, placebo-controlled trial included 298 patients who were undergoing a hematopoietic stem cell transplant (HSCT) for NHL at medical centers in the United States and Canada. It examined the effectiveness of Mozobil in increasing the number of hematopoietic stem cells collected for a transplant. The study compared the hematopoietic stem cell yield from patients treated with Mozobil in combination with G-CSF to patients treated with G-CSF in combination with placebo. G-CSF is the standard of care for stimulating the mobilization of stem cells from the bone marrow; Mozobil is designed to allow for the more rapid and effective release of those stem cells from the marrow into the circulating blood for collection by apheresis.

In the primary efficacy endpoint, 59 percent of patients treated with a combination of Mozobil and G-CSF achieved the target threshold for collection of at least 5 million CD34+cells/kg from the peripheral blood with four or fewer days of apheresis sessions, compared with 20 percent of patients in the G-CSF/placebo group. The three-fold increase was highly statistically significant in favor of the Mozobil-treated patients (p<0.0001). The 40 percent absolute difference between the two treatment groups was nearly double the target that Genzyme prospectively defined in the protocol for the study, which was reviewed by FDA as part of the Special Protocol Assessment process.

In the secondary efficacy endpoint, nearly 87 percent of patients treated with Mozobil and G-CSF achieved the minimum level of stem cells generally associated with a successful transplant (2 million CD34+cells/kg) in four or fewer days of apheresis sessions, compared with approximately 47 percent in the placebo arm. This result was also highly statistically significant in favor of the Mozobil-treated patients (p<0.0001).

The other secondary efficacy endpoints were supportive of these findings, including analysis of the number of days needed to reach target ranges for stem cell mobilization, the success of engraftment, the number of days needed to engraft, and the durability of the engraftment for the first 100 days.

Mozobil was well tolerated in the trial, with the most common adverse events being mild gastrointestinal effects and redness at the site of injection. There were two related serious adverse events seen in the Mozobil plus G-CSF arm, and one in the G-CSF plus placebo arm.

“These are very impressive results with far-reaching clinical importance for patients undergoing a stem cell transplant for lymphoma,” said Principal Investigator John F. DiPersio, M.D., Ph.D., professor, Washington University, St. Louis. “Current literature suggests that increasing the number of stem cells in circulation and the number collected at the time of apheresis may improve the outcomes of patients undergoing a stem cell transplant, reduce the costs associated with stem cell collection and, more importantly, broaden the pool of patients for whom transplantation is an option.”

Based on these results Genzyme expects to file for US and European approval in lymphoma in the first half of 2008. In addition, Genzyme is completing a second phase 3 trial of Mozobil in multiple myeloma, and results are expected in the coming weeks.

About Mozobil

Mozobil, a novel small molecule CXCR4 chemokine antagonist, has been shown in multiple earlier studies to rapidly and effectively increase the number of stem cells in circulation in the blood. Once circulating in the blood, stem cells can be collected for use in a stem cell transplant. Mozobil has been granted special protocol assessment and orphan drug status in the United States and European Union and the pivotal trials have undergone Special Protocol Assessment by the FDA and Protocol Assistance by the EMEA. Genzyme intends to commercialize Mozobil through its existing global transplant business to hematologists and hematopoietic stem cell transplant centers in more than 50 countries throughout the world. Genzyme has been developing Mozobil since its acquisition of AnorMED, Inc. in 2006.

Approximately 55,000 stem cell transplants are performed each year for multiple myeloma, Hodgkin’s and non-Hodgkin’s lymphoma, and other conditions in markets where Genzyme has a commercial infrastructure, including the United States, Europe, Latin America and the Asian Pacific countries.

About Genzyme

One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. Genzyme has been selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Medtronic Completes Implants in SANTE Trial of Deep Brain Stimulation for Epilepsy

2007-07-19T13:48:00.000-07:00

Medtronic, Inc. (NYSE: MDT), today announced the completion of implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the treatment of medically refractory epilepsy, a form of the neurological condition that does not respond to antiepileptic drugs. With 110 patients now implanted with the Intercept™ Epilepsy Control System, results of the study – the SANTE (Stimulation of the Anterior Nucleus of the Thalamus in Epilepsy) Trial – are expected to be available during 2008.

Ongoing at 17 medical centers in the United States, the SANTE Trial is using existing Medtronic DBS technology to determine whether bilateral stimulation of the anterior nucleus of the thalamus – the brain’s central message and relay station – can safely and effectively reduce seizure frequency in people with epilepsy. The same technology is approved for treating motor symptoms of Parkinson’s disease and essential tremor – the two most common movement disorders. It has been used by more than 40,000 people worldwide, however, Medtronic’s DBS therapy has not yet been approved for use in medically refractory epilepsy. Unlike other treatments that involve brain surgery, DBS therapy is non-destructive, adjustable and reversible.

All implanted patients in the SANTE Trial will be monitored for 13 months following implant, with long-term follow-up continuing until the device is approved for treating epilepsy or the study is stopped. Trial participants are adults with partial-onset epilepsy for whom at least three antiepileptic drugs have proven ineffective. (Individuals with partial-onset epilepsy have seizures that originate in a localized area of the brain.) To qualify for enrollment, study patients were required to have had an average of six or more seizures per month. They continue to receive their epilepsy medications while participating in the trial.

“Despite best medical management, a significant proportion of people with epilepsy continue to experience seizures that wreak havoc on their lives,” explained the trial’s principal investigator, Dr. Robert Fisher, professor of neurology and director of Stanford Epilepsy Center at Stanford University in Palo Alto, Calif. “For this underserved patient population, deep brain stimulation may represent a promising new treatment option.”

According to the Epilepsy Foundation, epilepsy and seizures affect more than three million Americans of all ages, at an estimated annual cost of $12.5 billion in direct and indirect costs. Despite trying a range of treatment options, about one-third of people with epilepsy continue to experience debilitating, recurring seizures – brief periods of abnormal electrical activity in the brain. The unpredictability of seizures affects daily activities and disrupts school days, work responsibilities and social functioning.

“The SANTE Trial is one of several major studies that Medtronic is sponsoring or supporting to establish compelling clinical evidence for approved and investigational applications of our neuromodulation technologies, which include implantable neurostimulation systems and site-specific drug-delivery systems,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic, Inc., and president of the Neuromodulation business unit. “With this latest milestone complete, we are one step closer to understanding the effectiveness of DBS therapy for patients with medically refractory epilepsy.”

Medtronic developed and leads the field of neuromodulation, the targeted and regulated delivery of electrical pulses and pharmaceuticals to specific sites in the nervous system. The company’s Neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder and urinary retention, benign prostatic hyperplasia, and gastroparesis.

ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

IBM Signs $1.4 Billion Global Strategic Outsourcing Agreement With AstraZeneca

2007-07-16T13:02:00.000-07:00

IBM (NYSE: IBM) today announced that they have signed a $1.4 billion, seven-year global strategic outsourcing agreement with AstraZeneca. The agreement renews and expands on the scope of an existing contract and covers the provision of IT infrastructure services to 60 countries. It includes services to additional functions within AstraZeneca, one of the world's largest pharmaceutical companies.

In the terms of the agreement, IBM will provide a single global technical infrastructure, managing IT services for AstraZeneca across its global organisation. This includes server and storage hosting, service desks, PC management, network and communications services, including e-mail, and computer operations support. AstraZeneca will retain control of its overall IT strategy and the development and support of its application systems.

Richard Williams, Chief Information Officer of AstraZeneca, said, "This innovative agreement with IBM will enable AstraZeneca to deliver greater value to the business by providing consistent infrastructure services globally, enabling a faster and more efficient rollout of new technology, with improved levels of service. Leveraging IBM's global delivery capabilities and economies of scale, will allow AstraZeneca to focus its efforts on adding value to its scientific, commercial and supply operations, thereby helping the Company to deliver more medicines that make a meaningful difference to patients. In allowing IBM greater autonomy on methods of delivery, the agreement will result in cost efficiencies when compared with running in-house systems."

"IBM will marshal its global resources to provide a flexible and agile infrastructure enabling AstraZeneca to continue implementing its plans to grow and lead in the pharmaceutical industry," said Doug Elix, Senior Vice President, IBM. "The trust we have built over the past seven years will help IBM and AstraZeneca break new ground in transformational services in the next seven."

The agreement was signed in July 2007.

About IBM
For more information on IBM, visit www.ibm.com.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

NicOx Receives Euro 5 Million Milestone From Merck as Drug Candidate Enters Clinic

2007-07-16T12:59:00.000-07:00

NicOx S.A. today announced that Merck & Co., Inc. has initiated the first in a series of planned clinical trials for the first selected drug candidate from the companies' major collaborative agreement to develop new nitric oxide- donating antihypertensive agents using NicOx' proprietary technology. The initiation of this clinical trial follows the review of an exploratory Investigational New Drug (IND) submission for this drug candidate by the US Food and Drug Administration (FDA) and results in a euro 5 million milestone payment from Merck & Co., Inc. to NicOx.

"We believe this candidate has considerable potential as an improved antihypertensive agent, based on its nitric oxide-donating properties," said Jacques Djian MD., NicOx' Cardiometabolic Area Leader. "There is evidence that endothelial nitric oxide plays an important role in the regulation of blood pressure and we believe that this drug candidate could satisfy the clear unmet medical need in the hypertensive market, where more than 40% of treated patients do not achieve blood pressure goals, even with the use of existing therapies. We are delighted that Merck has initiated clinical studies and hope this compound will deliver a major advance in antihypertensive treatment for patients worldwide."

The first trial in the clinical program for this candidate is a phase 1, dose-escalating study in healthy volunteers. The primary objective of this trial is to assess the safety, tolerability and pharmacokinetics of single oral doses, in order to select the dose and dosing regimen for further clinical studies. Merck is responsible for funding and performing the development of this compound going forward. The initiation of this clinical development program follows the announcement in January 2007 of the companies' selection of the first development candidate and that Merck had started the Good Laboratory Practice (GLP) compliant toxicology studies needed to submit an exploratory IND for this compound (see NOTE).

Including the euro 5 million milestone payment announced today, NicOx will have received euro 19.2 million from Merck under their current agreement, of which euro 10 million will have been received since the beginning of 2007. NicOx also stands to receive a potential additional euro 269 million in milestone payments and Merck will pay NicOx industry standard royalties on the sales of products that result from the agreement. Furthermore, NicOx has the option to co-promote products that result from the agreement, on a fee-for- detail basis, to specialist physicians in the United States and certain major European countries.

"NicOx and Merck have been successful in advancing this first compound into the clinic only sixteen months after the signature of our major agreement," said Michele Garufi, Chairman and CEO of NicOx. "We feel confident that the drug candidate resulting from this agreement with Merck, where we have a co-promotion option to specialist physicians in selected markets, together with our lead compound naproxcinod, will represent a solid and attractive basis to transform NicOx into an integrated pharmaceutical company."

NOTE: Submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) is necessary for obtaining approval to conduct clinical trials in humans in the United States. An IND contains information on preclinical toxicology and pharmacology studies in animals (collectively known as IND-enabling studies), in addition to details of the manufacturing of the compound and information prepared for future clinical investigators.

NicOx is a product-driven biopharmaceutical company dedicated to the development of nitric oxide- donating drugs to meet unmet medical needs. NicOx is targeting the therapeutic areas of inflammation and cardio-metabolic disease. Resources are focused on two lead compounds, naproxcinod (formerly HCT 3012); in phase 3 development for the treatment of signs and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2 diabetes.

NicOx has strategic partnerships with some of the world's leading pharmaceutical companies, including Pfizer Inc. and Merck and Co., Inc.

NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public company listed on the Eurolist of Euronext(TM) Paris (segment: Next Economy).

ROTATEQ and GARDASIL Adopted by All Immunization Projects of the Centers for Disease Control and Prevention's(CDC) Vaccines for Children(VFC) Program

2007-07-16T12:58:00.000-07:00

Merck & Co., Inc. announced today that both ROTATEQ (rotavirus vaccine, live, oral, pentavalent) and GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] have now been adopted by all 55 U.S.-based immunization projects of the Centers for Disease Control and Prevention's (CDC) Vaccines for Children (VFC) program. The 55 Immunization Projects include the 50 states in addition to city programs in Washington DC, New York City, Philadelphia, Chicago, and San Antonio.

"This milestone is an important step in Merck's ongoing commitment to make our vaccines available to all children who need them, regardless of income," said Mark Feinberg, M.D., Ph.D., vice president of policy, public health and medical affairs, Merck Vaccines. "The adoption of ROTATEQ and GARDASIL by all 55 immunization projects further demonstrates the value these vaccines provide, and we applaud the projects for their prompt action in ensuring timely access to these important vaccines."

Since 1994, the VFC program has provided vaccines to children who are Medicaid-eligible, uninsured, underinsured (when seen at a Federally Qualified Health Center or Rural Health Clinic), or Native American, providing coverage for many who do not have private health insurance.

ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3 and G4 when administered as a three-dose series to infants between the ages of six to 32 weeks. GARDASIL is indicated for girls and women ages nine to 26, for the prevention of cervical cancer; cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, non-invasive cervical cancer (CIN 3, AIS), VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases.

Merck's commitment to global vaccine access
Merck has submitted applications to seek World Health Organization (WHO) prequalification status for ROTATEQ and GARDASIL as part of the Company's commitment to making its vaccines available in the developing world. Applications for both vaccines have been accepted by WHO and are being reviewed. WHO prequalification verifies that vaccines meet the qualifications of quality, safety and efficacy for procurement by U.N. agencies, including UNICEF and the Pan American Health Organization (PAHO), and is an important step towards providing global access to these vaccines. "Merck is pursuing a systematic, thoughtful approach to the global introduction of ROTATEQ and GARDASIL - partnering with WHO, the GAVI Alliance and other international organizations, conducting global clinical trials and demonstration projects, and committing to making ROTATEQ and GARDASIL available at dramatically lower prices in GAVI-eligible countries," said Margaret G. McGlynn, president, Merck Vaccines.

Merck has made an important stride towards making ROTATEQ available in the developing world through its partnership with the Nicaraguan Ministry of Health (MOH) which was announced in September 2006. Through this joint project, aimed at demonstrating the public health impact of a full rotavirus vaccination program, all infants born in Nicaragua in a three-year period will receive free doses of ROTATEQ. This program represents a significant opportunity to add to the evidence base supporting the efforts of the global public health community to accelerate the introduction of routine rotavirus vaccination in resource-poor countries.

It is estimated that more than 60,000 infants have been vaccinated with ROTATEQ in Nicaragua in the six months since this partnership was initiated. The Nicaragua Rotavirus Vaccine Project marks the first time that a vaccine was introduced in a GAVI-eligible country in the same year it was approved by the U.S. Food and Drug Administration (FDA).

In December 2005, Merck entered into a partnership with PATH, an international non-profit group, to conduct clinical trials of ROTATEQ in Africa and Asia. The first infant was enrolled in a clinical trial in Bangladesh in March 2007. Trials are also under way in Ghana and Mali. Trials in Kenya and Vietnam are expected to begin this year.

Merck will also provide GARDASIL and technical support at no cost to PATH to support demonstration studies in India, Peru and Vietnam. These studies are designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. In addition, Merck is working with India's Council of Medical Research to study GARDASIL in India.

Merck has also initiated a new U.S. patient assistance program for vaccines for adults. Through this program, currently available in private physicians' offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in eligible individuals ages 19 and older who are uninsured and who are unable to afford vaccines.

Both vaccines were approved for use in the U.S. in 2006 and embraced by physicians, parents and public health authorities. The CDC recommends both vaccines as part of their recommended immunization schedule.

Select safety and additional information about ROTATEQ
ROTATEQ should not be administered to infants with a demonstrated history of hypersensitivity to any component of the vaccine.

No safety or efficacy data are available for the administration of ROTATEQ to infants who are potentially immunocompromised, including those who have received blood products within 42 days of vaccination.

More than 71,000 infants were evaluated in three placebo-controlled clinical trials. Serious adverse events occurred in 2.4 percent of recipients of ROTATEQ when compared to 2.6 percent of placebo recipients within the 42-day period of a dose of ROTATEQ. Hematochezia, reported as a serious adverse event for ROTATEQ compared to placebo, was less than 0.1 percent vs. less than 0.1 percent. The most frequently reported serious adverse events for ROTATEQ compared to placebo were bronchiolitis (0.6 percent vs. 0.7 percent), gastroenteritis (0.2 percent vs. 0.3 percent), pneumonia (0.2 percent vs. 0.2 percent), fever (0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs. 0.1 percent).

In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6 percent vs. 42.8 percent). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of ROTATEQ as compared with placebo recipients were diarrhea (24.1 percent vs. 21.3 percent), vomiting (15.2 percent vs. 13.6 percent), otitis media (14.5 percent vs. 13.0 percent), nasopharyngitis (6.9 percent vs. 5.8 percent), and bronchospasm (1.1 percent vs. 0.7 percent).

In post-marketing experience, cases of intussusception have been reported in temporal association with ROTATEQ.

As with any vaccine, vaccination with ROTATEQ may not result in complete protection in all recipients.

The first dose of ROTATEQ should be administered between six and 12 weeks of age, with the subsequent doses administered at four- to 10-week intervals. The third dose should not be given after 32 weeks of age. ROTATEQ was approved by the FDA on February 3, 2006.

Through June 2007, Merck has distributed more than six million doses of ROTATEQ. ROTATEQ has been approved in more than 60 countries around the world.

Select safety and additional information about GARDASIL
GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.

In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose. GARDASIL (sold in some countries as SILGARD®) has been approved in 80 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Through the first quarter of 2007, Merck distributed five million doses of GARDASIL.

Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com

GE Healthcare Financial Services Closes $3.3 Million Deal with BioStorage Technologies

2007-07-16T12:50:00.000-07:00

GE Healthcare Financial Services has provided a $3.3 million lease line of credit to BioStorage Technologies (BST). The Indianapolis, IN.-based company is a worldwide leader in short-term and long-term biomaterials storage, sample management and cold chain logistics. They will use the loan to support additional BST capital acquisitions.

In the near future, BST plans to purchase additional walk-in and stand-alone freezer units, back-up generators, liquid nitrogen tanks and other equipment to meet growing customer demands. In addition, BST will continue to build out its information technology infrastructure and software development needs.

“Having a strategic partner like GE Healthcare Financial Services has given us the financial flexibility to grow and execute our vision for the future,” said F. John Mills, M.D., Ph.D., BST’s chairman and chief executive officer. “GE HFS’ focus on helping us solve our financing needs allows us to create a broader leadership position in the drug research and development market.”

“GE Healthcare Financial Services is very pleased to have entered into a long-term partnership with BioStorage Technologies and we are focused on providing financial services that help them grow,” said Anthony Storino, senior managing director for GE Healthcare Financial Services’ life science finance group. “Our industry expertise and financial strength enabled us to quickly structure a tailored financing solution that recognized BioStorage Technologies’ current position in the market and will grow with their business.”

About GE Healthcare Financial Services

GE Healthcare Financial Services is a provider of capital, financial solutions, and related services for the global healthcare market. With over $16 billion of capital committed to the healthcare industry, GE Healthcare Financial Services offers a full range of capabilities from equipment financing and real estate financing to working capital lending, vendor programs, and practice acquisition financing. With its knowledge of all aspects of healthcare from hospitals and long-term care facilities to physicians’ practices and life sciences, GE Healthcare Financial Services works with customers to create tailored financial solutions that help them improve their productivity and profitability. For more information, visit http://www.gehealthcarefinance.com

Idenix Pharmaceuticals Halts Hepatitis C Drug Development in U.S.

2007-07-13T08:21:00.001-07:00

Idenix Pharmaceuticals today announced that after discussions with the United States Food and Drug Administration (FDA) the development program of valopicitabine (NM283) for the treatment of hepatitis C has been placed on clinical hold in the United States based on the overall risk/benefit profile observed to date in clinical testing.

"We are disappointed with the FDA's perspective on the program and are working with Novartis to evaluate our options for valopicitabine," said Jean- Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a successful launch of Tyzeka®/Sebivo® and on advancing our pipeline. We have a novel non-nucleoside reverse transcriptase inhibitor being evaluated in phase I clinical testing for the treatment of HIV. Additionally, we have a comprehensive HCV discovery effort, which includes a second-generation nucleoside polymerase inhibitor that is being evaluated in IND-enabling preclinical testing and novel HCV non-nucleoside polymerase inhibitor and HCV protease inhibitor programs."

As of June 30, 2007, Idenix had approximately $160 million of cash, cash equivalents and marketable securities.

"Over the next few weeks, we will be taking a critical look at our expenses with the goal of investing in programs that we believe will create shareholder value," said Ronald Renaud, chief financial officer of Idenix. "Our balance sheet is strong and we believe that we have enough cash to fund early clinical development of the pipeline."

Conference Call Information

Idenix will hold a conference call today at 8:00 a.m. EDT. To access the call please dial (800) 774-5358 U.S./Canada or (706) 758-9475 International and enter passcode 7177935 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection. A replay of the conference call and webcast will be available until July 30, 2007. To access the replay, please dial (800) 642-1687 U.S./Canada or (706) 645-9291 International and enter the passcode 7177935.

About Idenix

Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com.

Sciele Pharma Signs Agreement with Addrenex Pharmaceuticals to Market CLONICEL

2007-07-13T08:14:00.000-07:00

Sciele Pharma, Inc. (NASDAQ: SCRX) today announced that it has signed an exclusive agreement with Addrenex Pharmaceuticals, Inc. to market, upon approval by the U.S. Food & Drug Administration (FDA), CLONICEL(R), a patented, sustained-release formulation of clonidine hydrochloride for the treatment of hypertension and attention deficit and hyperactivity disorder in North America. Sciele will also have the right of first refusal for other Addrenex products focused on pediatrics, women's health, and cardiovascular/metabolic diseases. Under the terms of the agreement, Sciele has purchased a $6 million equity stake in Addrenex and will have the right to increase its equity stake in Addrenex by an additional 10%. Sciele will also make regulatory milestone payments of up to $11 million and royalty payments to Addrenex on product sales.

Clonidine hydrochloride is an alpha-2 agonist approved for the treatment of hypertension. During the past year, approximately 11.7 million prescriptions were dispensed for clonidine hydrochloride tablets and approximately 1.8 million prescriptions were dispensed for clonidine patches, according to IMS Health's National Prescription Audit Plus data. CLONICEL(R) is a 12-hour, sustained-release formulation of clonidine hydrochloride, which currently is in pivotal clinical trials for hypertension. A 505(b)(2) NDA filing with the FDA is expected in the second half of 2007. A Phase III clinical trial utilizing CLONICEL(R) for ADHD is expected to begin in the second half of 2007.

Patrick Fourteau, Chief Executive Officer of Sciele Pharma, said, "This agreement with Addrenex provides us with the opportunity to further expand both our cardiovascular and pediatric product lines. We continue to execute on our strategy to diversify our product portfolio and expand our late-stage product pipeline through the licensing and acquisition of products."

Moise Khayrallah, Ph.D., Chief Executive Officer of Addrenex, said, "We are very happy that a successful company such as Sciele sees the potential of our lead compound CLONICEL(R). We look forward to a rewarding partnership that will allow Addrenex to develop and commercialize this product as well as future compounds in our adrenergic regulation portfolio."

About Sciele Pharma, Inc.

Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and Type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele Pharma employs more than 900 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity, and Teamwork.

About Addrenex Pharmaceuticals, Inc.

Addrenex Pharmaceuticals is a focused, specialty pharmaceutical company that develops and commercializes drugs to treat adrenergic dysregulation. Addrenex Pharmaceuticals is based in Morrisville, North Carolina, on the edge of Research Triangle Park. The company was formed in 2006 by a practicing physician and a drug development expert with the mission to explore the impact that neurotransmitter regulation has on a variety of diseases and disorders. Addrenex identified adrenergic regulation as its initial research focus. Adrenergic dysregulation is implicated in medical conditions such as hypertension, ADHD, migraine, and post-menopausal symptoms. Addrenex will use the knowledge and experience gained from developing CLONICEL(R) as the foundation for additional discovery and development in the area of adrenergic regulation.

Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program

2007-07-13T07:04:00.000-07:00

Amgen today announced that its board of directors has authorized additional repurchases of up to $5 billion in Amgen common stock. The company currently has $1.5 billion remaining under its previous stock repurchase authorization. This new authorization reflects Amgen's confidence in its long-term prospects.

About Amgen

Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com

Bayer CropScience’ Nunhems acquires Korean vegetable seed company SeedEx

2007-07-13T06:56:00.000-07:00

Bayer CropScience announced today that Nunhems, its vegetable seed business, has completed the acquisition of the assets of the South Korean vegetable seed company SeedEx which specializes in the breeding, production and marketing of Hot pepper and Brassica varieties. Both crops belong to the most important vegetable crops in Asia in terms of acreage and consumption. The Korean authorities had approved the transaction. Financial terms were not disclosed.

The acquisition strengthens Nunhems’ business in the Asia/Pacific region offering access to new Asian markets as well as growth opportunities in other regions of the world. With both crops being strategic crops for Nunhems the germplasm and breeding activities of SeedEx ideally complement Nunhems’ portfolio. Furthermore, the acquisition will bring in specifically skilled and knowledgeable staff.

Mr. Douwe Zijp, Chief Executive Officer of Nunhems comments: “The acquisition of SeedEx is an important step to strengthen our market position in Hot Pepper and Brassica in Asia. The SeedEx team with its well recognized breeding competence and market know-how will be an excellent reinforcement of our global teams.”

Mr. Sang Gil Lee, Managing Director SeedEx comments: “I am proud that my team becomes part of a global specialist company in vegetables seeds. Nunhems will supply additional resources, practical expertise and know-how on biotechnological support for the creation of new varieties.”

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer CropScience AG, a subsidiary of Bayer AG with annual sales of about EUR 5.7 billion (2006), is one of the world’s leading innovative crop science companies in the areas of crop protection, non-agricultural pest control, seeds and plant biotechnology. The company offers an outstanding range of products and extensive service backup for modern, sustainable agriculture and for non-agricultural applications. Bayer CropScience has a global workforce of about 17,900 and is represented in more than 120 countries. This and further news is available at: www.newsroom.bayercropscience.com.

The company’s vegetable seed business operates under the name of Nunhems. Nunhems® is the global specialist in vegetable seeds and sharing smart products, concepts and expertise with the professional horticultural production industry and supply chain. Its portfolio includes leading varieties and brands in crops such as leek, onion, carrot, melon, cucumber, tomato, watermelon, lettuce, pepper and chicory witloof. With annual sales of EUR 190 million in 2006, Nunhems is among the worldZs four leading vegetable seed companies with an extensive rate of 28 species and some 2,500 varieties. With more than 1,200 people Nunhems is present in all major vegetable production areas in the world.

Find more information at www.bayercropscience.com

Labopharm and Paladin Labs Ink Tramadol Agreement

2007-07-13T06:53:00.000-07:00

Labopharm and Paladin Labs Inc. today announced that they have completed a licensing and distribution agreement under which Labopharm has granted Paladin the exclusive right to market and sell Labopharm's once-daily tramadol product in Canada. Labopharm will retain co-promotion rights.

"With sales and marketing expertise specific to the pain and central nervous system areas and a strong commitment to our product, Paladin is the right marketing partner for our once-daily tramadol in Canada," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that our once-daily tramadol product will fulfill a need not currently being met within the pain treatment landscape in Canada."

"With considerable sales potential, Labopharm's once-daily tramadol will become the flagship product in our pain portfolio," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "We look forward to launching this unique product into the large and growing Canadian pain treatment market, which in 2006 reached almost 26 million prescriptions representing sales of more than $800 million."

Under the terms of the agreement, Labopharm will receive a transfer price on packaged product supply based on a percentage of the anticipated selling price. Labopharm expects to generate a gross margin on Canadian sales in excess of what the Company is currently experiencing in Europe. Labopharm will also receive up front and milestone payments of up to $1.5 million from Paladin.

The two companies expect the product to be launched in Canada this year.

About Labopharm's Once-Daily Tramadol Product

Labopharm's once-daily tramadol product is based on the Company's proprietary Contramid® technology, which provides a dual matrix delivery system allowing both rapid and sustained drug release that maintains blood levels within the therapeutic range providing a full 24 hours of pain relief. The Company believes that maintaining drug concentrations within the therapeutic range has the advantage of fewer and less severe side effects while maintaining efficacy. Under its global commercialization program, Labopharm's once-daily tramadol product has been approved in 28 countries and a broad European launch is underway.

About Tramadol

Tramadol is a centrally acting analgesic for the treatment of moderate to severe pain. Tramadol has a 30-year history of efficacy and safety and is currently marketed in more than 70 countries worldwide, primarily in formulations that require multiple doses per day. Studies have shown that tramadol provides relief from both acute and chronic pain conditions, including osteoarthritis pain, low back pain, cancer pain, post-operative pain and dental pain. Tramadol avoids the potentially serious side effects such as gastrointestinal bleeding that may be caused by NSAIDs and the potential cardiovascular events recently attributed to COX-2 inhibitors. Compared to stronger opioids, tramadol has, in clinical studies, demonstrated a lower incidence of major side effects, such as respiratory depression.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is being commercially launched in key markets globally. The Company has a robust pipeline of follow-on products in both pre-clinical and clinical development. For more information, please visit www.labopharm.com

About Paladin Labs Inc.

Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. For more information, please visit the Company's web site at www.paladinlabs.com

New Brunswick Scientific and Eppendorf AG Enter Into $110 Million Merger Agreement

2007-07-13T06:48:00.000-07:00

New Brunswick Scientific Co., Inc. ("NBS") , and Eppendorf Group ("Eppendorf") today announced that they have entered into a merger agreement whereby Eppendorf will acquire the outstanding common stock of NBS for $11.50 per share. Eppendorf has also agreed to settle all the outstanding stock options of NBS for cash. The total value of the transaction, including the settlement of the stock options, is approximately $110 million.

NBS President and Chief Executive Officer James T. Orcutt commented, "The NBS Board has unanimously approved this merger and believes that it is in the best interests of shareholders. Furthermore, the Board recommends that shareholders approve the merger agreement."

The closing of the transaction is subject to customary closing conditions, including receipt of regulatory approvals and the approval of the NBS shareholders. The parties anticipate consummation of the transaction sometime during the third quarter of 2007. Upon completion of the transaction, NBS will become a wholly owned subsidiary of Eppendorf and its common stock will no longer be publicly traded.

Eppendorf has also received commitments from David Freedman, co-founder and chairman of NBS, other Freedman family members and certain members of the executive management and board of directors of NBS representing nearly 26% of the currently outstanding shares to vote their shares in support of the merger. Mr. Freedman stated, "While there is always some sadness in selling the company that we have built, I am pleased that Eppendorf is the buyer. This well-regarded manufacturer offers the opportunity to continue the NBS brand, to support our customers and our products, and to offer the opportunity for our employees to continue with NBS."

Following closing of this acquisition, Eppendorf expects to operate New Brunswick as a Center of Excellence as part of its international activities. In addition to the existing NBS sales force, Eppendorf will enable NBS to benefit from Eppendorf's global distribution network to accelerate the long- term growth of the combined product range.

"Eppendorf is committed to providing our customers products and services that deliver them superior technology, quality, reliability and value. Our customers consider Eppendorf as one of the strongest brands amongst life science tools suppliers. Our growth strategy seeks to build upon these unique competitive advantages, including through acquisitions that seamlessly integrate into our pre-eminent brand position and product range. NBS's strong brand recognition and leadership position in complementary market segments makes this a compelling acquisition opportunity for Eppendorf," said Klaus Fink, chief executive officer of Eppendorf.

Mr. Fink continued, "Like Eppendorf, NBS enjoys a rich history and culture of innovation that seeks to develop solutions that address the unique needs of our customers. This combination offers our customers even greater value, as the combined company can address a broader range of their needs through more comprehensive solutions across equipment, consumables and global service. We are excited to welcome NBS and its employees into the Eppendorf family. Our similar histories and cultures create a solid basis for future successes together."

Deutsche Bank acted as financial advisor to Eppendorf, and Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor to Eppendorf. EuroConsult, Inc. acted as financial advisor to NBS, CBIZ Valuation Group, LLC provided a fairness opinion to the Board of Directors of NBS and Morgan, Lewis & Bockius LLP acted as legal advisor to NBS.

About New Brunswick Scientific

New Brunswick Scientific Co., Inc., is a leading global innovator providing a comprehensive line of equipment and instrumentation for the life science industry. NBS's products are used in the creation, maintenance and control of physical and biochemical environments required for the growth, detection and storage of microorganisms for medical, biological and chemical applications, environmental research and commercial products. Established in 1946, NBS is headquartered in Edison, New Jersey, with sales and distribution facilities located in the United States, Europe and Asia.

News releases and other information on NBS are available on the Internet at: http://www.nbsc.com

About Eppendorf

Eppendorf is a global leader in laboratory equipment and associated consumables. Eppendorf products include liquid handling and centrifugation equipment products including related consumables as well as instruments and systems for PCR, cell technology and micro arrays that are used by researchers in life science, drug discovery, clinical, environmental and industrial laboratories. Founded in 1945, Eppendorf, a privately-held company headquartered in Hamburg, Germany, has revenues of more than $400 million, and employs approximately 2,000 people in over 20 countries.

News releases and other information on Eppendorf are available on the Internet at: http://www.eppendorf.com

Important Additional Information Will be Filed with the SEC

NBS plans to file with the SEC a proxy statement in connection with the transaction. NBS shareholders are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about NBS, Eppendorf and the proposed transaction. The final proxy statement will be mailed to shareholders of NBS. In addition to the documents described above, NBS files annual, quarterly and current reports, proxy statements and other information with the SEC. The proxy statement and other relevant materials (when they become available), and any other documents filed with the SEC by NBS, are available without charge at the SEC's website at http://www.sec.gov, or at NBS's website at http://www.nbsc.com.

Participants in Solicitation

Neither NBS nor Eppendorf is currently engaged in a solicitation of proxies from the shareholders of NBS in connection with the proposed transaction. If a proxy solicitation commences, NBS, Eppendorf and their respective directors and officers and other members of management may be deemed to be participants in such solicitation. Information regarding NBS directors and executive officers is available in its Annual Report on Form 10- K for the year ended December 31, 2006, and its proxy statement, dated April 24, 2007, for its 2007 annual meeting of shareholders, which are filed with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and other relevant documents to be filed with the SEC in connection with the proposed transaction.

YAZ approved in the Netherlands as European Reference Member State

2007-07-13T06:36:00.000-07:00

Bayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® (3 mg drospirenone/20 mcg ethinyl estradiol) in the Netherlands. YAZ® will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.

“We are very excited about this first European approval for YAZ®. YAZ® is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ® offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of Women’s Healthcare at Bayer Schering Pharma AG.

YAZ®, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ® is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ® was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ® becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.

About YAZ®
Like Yasmin®, the number one brand birth control pill worldwide, YAZ® contains the innovative progestin drospirenone. Drospirenone exhibits unique antimineralcorticoid and antiandrogenic properties, unlike any other progestin available in oral contraceptives. Due to drospirenone’s antiandrogenic action, YAZ® can be used for the treatment of acne, which is primarily caused by an increased production and/or activity of male sex hormones (androgens).

YAZ® has a new dosing regimen of 24 days of active hormone pills and four days of placebo. This innovative regimen combined with drospirenone’s benefits reduces typical monthly hormonal fluctuations compared to traditional oral contraceptives with intake regimens of 21 days of active pills and seven days of placebo.

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de

Medtronic Insertable Heart Monitor Gives New Insight Into Heart Rhythm Disorder

2007-07-09T13:32:00.000-07:00

Today Medtronic, Inc. (NYSE: MDT) announced the European introduction of Reveal® XT, the first Insertable Cardiac Monitor that offers long-term and continuous monitoring of Atrial Fibrillation (AF). All other current monitoring tools are either for a limited period or on an intermittent basis. Long-term, continuous monitoring means that a clinician no longer needs to rely only on incomplete data to evaluate how AF may be progressing or treatment effectiveness. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal XT took place at Asklepios Klinik St. Georg in Hamburg, Germany by Prof. Karl-Heinz Kuck, M.D. The Reveal XT insertable cardiac monitor is not currently available for sale in the United States.

AF is the most common cardiac arrhythmia, experienced by 4.5 million patients in Europe1. Treatment of AF is difficult as episodes often show no symptoms and therefore go unnoticed by patients2. Yet the risks are well known – AF can lead to a two to seven times higher risk of stroke1, an increased risk of heart failure and sudden cardiac death3 due to inefficient pumping in the heart.

“Atrial fibrillation is the most frequent cardiac arrhythmia. It is often accompanied by symptoms that are very unpleasant for the patient,” said Prof. Kuck, Hanseatisches Herzzentrum / Department of Cardiology, Asklepios Klinik St. Georg. “Moreover, atrial fibrillation is linked with increased mortality and an increase in the incidence of stroke, by a factor of two- to seven-fold. However, with the new Reveal XT, atrial fibrillation can now be scrutinized over a period of three years with a subcutaneous monitor. This gives us totally new possibilities for monitoring and adjusting the treatment.”

The Only Way of Precisely Treating AF Is Knowing AF
The Reveal XT Insertable Cardiac Monitor monitors AF patients 24 hours a day, every day for up to three years. There are a variety of ways to treat AF, but up until now physicians had no means of gathering detailed data, over an extended period, on the progression of AF and the effect of treatment. Reveal XT gives new insight into patients’ heart rhythms, which may help physicians to evaluate stroke risk and determine appropriate treatment and therapy options for their patients.

24/7 Monitoring Provides Patient Compliance
As Reveal XT is inserted just under the skin, the patient experiences no restrictions in daily activities. This is not only more comfortable for the patient, but also ensures that cardiac data recorded is not influenced by restrictions in activities. Patients continue to lead their normal life and therefore heart activity recorded shows real-life, relevant information. Once patients leave the clinic, Reveal XT does not require wires or sticky pads to monitor the patients’ heart rhythms.

1 ACC/AHA/ESC Guidelines for the Management of Patients with Atrial Fibrillation
2 T. Fetsch, EHJ. 2004;1385-1394
3 A. Krahn et al. Am J Med. 1995; 98:476-484

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

New Medtronic Implantable Cardiac Monitor Gives Physicians Valuable Insights Into the Cause of Unexplained Fainting

2007-07-09T13:31:00.000-07:00

Medtronic, Inc. (NYSE: MDT) today announced the European introduction of the Reveal® DX, a new Insertable Cardiac Monitor that offers diagnostic and monitoring information related to syncope (fainting) in patients. The device recently received CE (Conformité Européenne) Mark, and the first implant of Reveal DX took place at Ospedali del Tigullio in Lavagna, Italy, by Prof. Michele Brignole, M.D. Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the monitor records important data before, during and after a syncopal event. This data enables the physician to diagnose the patient and determine the right treatment based on long-term cardiac rhythm trend data. The Reveal DX insertable cardiac monitor is not currently available for sale in the United States.

Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown¹. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

With the information obtained from the Reveal DX, the physician can understand if the cause of syncope is cardiac related, which may help to appropriately manage the patient’s arrhythmia.

“Syncope can cause a considerable degree of anxiety and activity restrictions for people,” said Prof. Brignole of the Department of Cardiology, Ospedali del Tigullio. “Application of this insertable cardiac monitor helps me to diagnose the underlying cause of syncope so that I can treat my patients appropriately.”

Always on Watch
The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Reveal DX is the only insertable cardiac monitor that can record an ECG at the time of a syncopal episode.

¹E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Johnson & Johnson Announces $10 Billion Share Repurchase Program

2007-07-09T13:30:00.000-07:00

Johnson & Johnson today announced that its Board of Directors has approved a share repurchase program, authorizing the Company to purchase up to $10 billion of the corporation's shares of common stock.

"This share repurchase program is consistent with our strategy of providing value to our shareholders while maintaining flexibility to continue to invest in future growth opportunities," said William C. Weldon, Chairman and Chief Executive Officer.

Share repurchases will take place on the open market from time to time based on market conditions. The repurchase program has no time limit and may be suspended for periods or discontinued at any time. Any shares acquired will be available for general corporate purposes. The Company had approximately 2,896.6 million shares of common stock outstanding as of April 29, 2007.

The Company intends to finance the share repurchase program through a combination of available cash and debt. The Company expects to retain its triple-A credit rating. Johnson & Johnson will discuss the share repurchase plan on its second-quarter earnings conference call on July 17, 2007.

Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 121,000 men and women in 57 countries and sell products throughout the world.

Phase III Trial Results Show Superiority of Rivaroxaban over Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Knee Repla

2007-07-09T13:23:00.000-07:00

Late-breaking Phase III clinical trial data presented today at the XXI International Society on Thrombosis and Haemostasis (ISTH) Congress demonstrate that once-daily rivaroxaban achieved superior efficacy in the prevention of venous thromboembolism (VTE) in patients undergoing knee replacement surgery in a head-to-head comparison with enoxaparin, the current standard of care. Patients in the RECORD3 (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) study who were treated with rivaroxaban demonstrated a 49 percent relative risk reduction (RRR) (p<0.001) in the composite primary endpoint of deep vein thrombosis (DVT), non-fatal pulmonary embolism (PE) and all-cause mortality compared to those treated with enoxaparin. A 62 percent reduction of risk (p=0.01) for developing major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the secondary endpoint of the trial – was observed in the patients treated with rivaroxaban. Rivaroxaban also demonstrated a similarly low rate of major bleeding compared to enoxaparin (0.6 percent and 0.5 percent, respectively).

Rivaroxaban is an investigational, oral, once-daily direct Factor Xa inhibitor. It is an anticoagulant – a drug designed to prevent and treat blood clots – in advanced clinical development for the prevention and treatment of thrombosis in acute and chronic settings, enabling convenient administration in both the hospital and at home.

Rivaroxaban is being jointly developed by Johnson & Johnson Pharmaceutical Research & Development L.L.C. and Bayer HealthCare AG.

Lead RECORD3 investigator, Michael R. Lassen, MD, of Hoersholm Hospital, University of Copenhagen, Denmark, commented: "The RECORD3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery. It's an important step for this category that a once-daily, oral medication has demonstrated better efficacy in preventing VTE than the current standard of care, while also displaying a promising safety profile. In addition, it is important to note that symptomatic VTE, a secondary endpoint of the study, showed results in favour of rivaroxaban."

Detailed Study Results

RECORD3 is a 2,531-patient, phase III, double-blind trial that assessed the safety and efficacy of 10 mg oral, once-daily rivaroxaban started six-eight hours after surgery versus 40 mg subcutaneous, once-daily enoxaparin started the evening before surgery in elective total knee replacement (TKR) surgery. Both regimens were continued for 10-14 days. The primary efficacy endpoint of the study was the composite of DVT, as diagnosed by mandatory venography, non-fatal PE and all-cause mortality. The primary safety endpoint was major bleeding. Results showed that DVT, non-fatal PE and death occurred in 9.6 percent (79/824) of patients receiving rivaroxaban versus 18.9 percent (166/878) of patients receiving enoxaparin (RRR 49 percent; p < 0.001).

Major VTE (the composite of proximal DVT, non-fatal PE and VTE-related death) – the main secondary efficacy endpoint of the study – occurred in 1.0 percent of the rivaroxaban-treated group and in 2.6 percent of the enoxaparin-treated group. The difference was statistically significant (p=0.01) in favour of rivaroxaban, with an RRR of 62 percent. A reduction was also demonstrated in symptomatic VTE, a pre-specified additional secondary endpoint in the study. Symptomatic VTE occurred in 1.0 percent of patients who received rivaroxaban, compared to 2.7 percent of those in the enoxaparin comparator group, resulting in an RRR of 64 percent.

In the rivaroxaban- and enoxaparin-treated groups, major bleeding rates were 0.6 percent and 0.5 percent, and any bleeding rates were 4.9 percent and 4.8 percent, respectively. The RECORD3 trial demonstrated superior efficacy of rivaroxaban versus enoxaparin, with similarly low bleeding rates, in patients undergoing TKR.

Garry Neil, MD, group president for central nervous system and internal medicine research & development at Johnson & Johnson Pharmaceutical Research and Development commented: "We believe rivaroxaban could alter the landscape of antithrombotic therapy. An effective once-daily oral anticoagulant that can be administered safely and conveniently in the hospital and home settings has the potential to improve upon current therapies and help to treat the significant number of under- and un-treated patients at risk for life-threatening thrombotic events."

The trade name of rivaroxaban is expected to be Xarelto®, pending health authority approval.

Results from other phase III trials in the RECORD program, RECORD1 and RECORD2 are expected to be available by H2 2007.

Unmet Needs in Venous Thromboembolism (VTE)

VTE is a type of thromboembolic disease that affects approximately 6.5 million people worldwide annually. Thromboembolic disease, which is caused by the obstruction of a blood vessel by a blood clot, is a leading cause of global mortality and a concern for many patient populations, including those with atrial fibrillation at risk for stroke; those at risk for myocardial infarction (heart attack); those undergoing orthopaedic surgery at risk for developing DVT and PE; and hospitalized, medically ill patients immobilized by cancer, congestive heart failure, acute respiratory disease, or other illnesses.

About Rivaroxaban (Xarelto®)

Phase IIb data – presented at ISTH in 2005, and published in the Journal of Thrombosis and Haemostasis in 2005 and 2006, and the additional once-daily ODIXa HIP study published in Circulation in 2006 – indicate that rivaroxaban offers predictable anticoagulation, which strongly suggests that routine coagulation monitoring will not be required. In addition, data show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.

To date, rivaroxaban is the most studied oral direct Factor Xa inhibitor in development.

More than 15,000 patients have been evaluated in the completed phase II programs and enrolled thus far in the phase III programs. More than 40,000 patients are expected to be evaluated in total.

The RECORD3 trial is part of the joint clinical development program led by Johnson & Johnson Pharmaceutical Research and Development and Bayer HealthCare. Upon regulatory approval, rivaroxaban will be commercialized in the United States by Scios Inc. and Ortho-McNeil, Inc. Bayer Schering Pharma will market rivaroxaban throughout the rest of the world.

The companies plan to submit regulatory filings for the prevention of VTE in orthopaedic surgery in late 2007 in Europe and in 2008 in the United States.

About Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is part of Johnson & Johnson, the world's most broadly based producer of health care products. Johnson & Johnson Pharmaceutical Research and Development is headquartered in Raritan, NJ, and has facilities throughout Europe and the United States. Johnson & Johnson Pharmaceutical Research and Development is leveraging drug discovery and drug development in a variety of therapeutic areas to address unmet medical needs worldwide.

Roche Holding and Alnylam Pharmaceuticals Form $1 Billion Alliance on RNAi Therapeutics

2007-07-09T09:42:00.000-07:00

Roche and the US-based biopharmaceutical company Alnylam Pharmaceuticals, Inc. announced today that they have entered into a major alliance in which Roche obtains a non-exclusive license to Alnylam's technology platform for developing RNAi (RNA interference) therapeutics. The alliance will initially cover four therapeutic areas: oncology, respiratory diseases, metabolic diseases and certain liver diseases. Alnylam and Roche also will collaborate on RNAi drug discovery for one or more disease targets in these therapeutic areas. In addition, Roche will acquire Alnylam's European research site located in Kulmbach, Germany (Bavaria), subject to regulatory approval.

This site will become Roche's Center of Excellence for RNAi therapeutics discovery.

RNAi is a potential foundation for a whole new class of human therapeutic products. RNAi is a natural mechanism that the body uses to inhibit expression of certain genes. Harnessing the activity of RNAi creates a direct opportunity to develop specific and potent drugs against diseases that are difficult to treat.

"Alnylam has made significant advances in RNAi therapeutics, one of the most promising approaches to tomorrow's healthcare technology. Working together with Alnylam provides us with new capabilities to target complex diseases within our focus areas," said Lee E. Babiss, Head of Roche Global Pharma Research. "Our mission is to find novel solutions for patients who suffer from difficult to treat diseases and we will be fully committed to this goal, together with our new colleagues located at the acquired site in Kulmbach."

"We are pleased to form this new alliance with Roche, which is widely recognized for its commitment to innovation in biotechnology. We look forward to working together to advance our transformative technology into a whole new class of drugs," said John Maraganore, Ph.D., President and Chief Executive Officer of Alnylam. "Such significant support from Roche will also strengthen Alnylam's efforts to build a leading innovation-based biopharmaceutical company. Indeed, together with our demonstrated commitment to scientific excellence, advancement of our pipeline and unparalleled intellectual property estate, we believe that this new alliance greatly extends our leadership position in the discovery and development of RNAi therapeutics."

Alnylam-Roche Collaboration

Alnylam has granted to Roche a non-exclusive license providing Roche access to broad Alnylam intellectual property (IP) and know-how, including fundamental, chemistry and delivery IP. Indications will initially include oncology, respiratory disease, metabolic disease and certain liver diseases. Alnylam maintains the right to non-exclusively license its IP to additional partners in potential future agreements. In addition, Alnylam and Roche will collaborate on one or more disease targets to be identified in the future in exchange for milestone and royalty payments.

The transaction includes Roche's acquisition of Alnylam's European research site in Kulmbach, Germany (Bavaria), with about 40 employees. The team in Kulmbach will remain dedicated to RNAi therapeutics discovery as a new Center of Excellence for RNAi therapeutics within Roche's global research organization.

The alliance could be valued at over 1 billion US dollars in consideration of upfront payments, potential product milestone payments for multiple products and field expansion payments, excluding potential royalties on future sales of commercial products. Under the terms of the agreement, Roche will pay Alnylam 331 million US dollars in upfront cash payments and equity investment, including 1.975 million shares of Alnylam common stock the Roche Venture Fund agreed to purchase at 21.50 US dollars per share, representing just less than five percent of Alnylam's outstanding common stock. Roche will also pay Alnylam milestones on products as they advance in development and commercialization as well as royalties on future sales of commercial products. Further, Roche may pay Alnylam field expansion payments to increase the number of therapeutic areas.

The close of the agreements, including Roche's purchase of Alnylam shares and purchase of Alnylam's site in Germany, is subject to certain regulatory approvals and is expected to occur within approximately 30 days.

About RNAi

RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the Nobel Prize in October 2006. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics target the cause of diseases by potently silencing specific messenger RNAs (mRNAs), thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.

About Alnylam Pharmaceuticals

Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is applying its therapeutic expertise in RNAi to address significant medical needs, many of which cannot effectively be addressed with small molecules or antibodies, the current major classes of drugs.

Alnylam is leading the translation of RNAi as a new class of innovative medicines with peer-reviewed research efforts published in the world's top scientific journals including Nature, Nature Medicine, and Cell. The company is leveraging these capabilities to build a broad pipeline of RNAi therapeutics; its most advanced program is in Phase II human clinical trials

for the treatment of respiratory syncytial virus (RSV) infection. In addition, the company is developing RNAi therapeutics for the treatment of influenza, hypercholesterolemia, and liver cancers, amongst other diseases. The company's leadership position in fundamental patents, technology, and know-how relating to RNAi has enabled it to form major alliances with leading companies including Merck, Medtronic, Novartis, Biogen Idec, and Roche. The company, founded in 2002, maintains global headquarters in Cambridge, Massachusetts. For more information, visit http://www.alnylam.com/.

About the Roche Venture Fund

The Roche Venture Fund makes investments in early stage biotech and diagnostics companies to support innovative technologies and medicines. Based in Basel, Switzerland, the Roche Venture Fund manages a portfolio of over 25 companies in 10 countries.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life.

Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006, sales by the Pharmaceuticals Division totaled 33.3 billion Swiss francs ($26.6 billion US), and the Diagnostics Division posted sales of 8.7 billion Swiss francs ($6.96 billion US). Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at http://www.roche.com/.

Depomed Reaquires Rights to ProQuin XR

2007-07-05T08:23:00.001-07:00

Depomed, Inc. announced today it has ended the license agreement and the related supply and co-promotion agreements with Esprit Pharma for ProQuin® XR, the extended release formulation of ciprofloxacin hydrochloride for the treatment of uncomplicated urinary tract infections.

Pursuant to the termination agreement, Esprit has paid Depomed $17,500,000. Esprit will also return the ownership of the Proquin NDA to Depomed along with all promotional materials. In addition, the parties have agreed to a detailed transition plan with specific activities and timelines related to the transition of the product from Esprit to Depomed. Depomed will leverage the commercial distribution network it has established for Glumetza to book sales and distribute Proquin in the US.

"We are happy to have ProQuin back," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We believe ProQuin will be a success, and we are continuing our discussions with potential new partners. We worked closely with Esprit to unwind the ProQuin agreements in a manner that assures our ability to continue commercializing ProQuin and appreciate their efforts in reaching this amicable agreement."

About ProQuin® XR

ProQuin XR is a once-daily extended-release formulation of ciprofloxacin hydrochloride and is indicated to treat uncomplicated urinary tract infections (UTIs). UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Patients should not take Proquin XR if they are allergic to, or have ever had a severe reaction to, ciprofloxacin or to any other "quinolone" antibiotics. ProQuin XR is generally well tolerated. The most common side effects with ProQuin XR include vaginal yeast infection and headache.

About Depomed

Depomed, Inc., is a specialty pharmaceutical company with two approved products on the market and multiple product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals include the convenience of once-daily administration, improved treatment tolerability and enhanced compliance and efficacy. Glumetza(TM) (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in the United States by King Pharmaceuticals and in Canada by Biovail Corporation. ProQuin® XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections. Product candidate Gabapentin GR(TM) is currently in Phase 3 and Phase 2 clinical development for the treatment of two pain indications, postherpetic neuralgia and diabetic peripheral neuropathy, respectively. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is also underway. Additional information about Depomed may be found on its web site, www.depomedinc.com

Scientists Discover Key to Manipulating Fat

2007-07-03T08:13:00.000-07:00

In what they call a “stunning research advance,” investigators at Georgetown University Medical Center have been able to use simple, non-toxic chemical injections to add and remove fat in targeted areas on the bodies of laboratory animals. They say the discovery, published online in Nature Medicine on July 1, could revolutionize human cosmetic and reconstructive plastic surgery and treatment of diseases associated with human obesity.

Investigators say these findings may also, over the long-term, lead to better control of metabolic syndrome, which is a collection of risk factors that increase a patient’s chances of developing heart disease, stroke, and diabetes. Sixty million Americans were estimated to be affected by metabolic syndrome in 2000, according to a study funded by the Centers for Disease Control in 2004.

In the paper, the Georgetown researchers describe a mechanism they found by which stress activates weight gain in mice, and they say this pathway ? which they were able to manipulate ? may explain why people who are chronically stressed gain more weight than they should based on the calories they consume.

This pathway involves two players ? a neurotransmitter (neuropeptide Y, or NPY) and the receptor (neuropeptide Y2 receptor, or Y2R) it activates in two types of cells in the fat tissue: endothelial cells lining blood vessels and fat cells themselves. In order to add fat selectively to the mice they tested, researchers injected NPY into a specific area. The researchers found that both NPY and Y2R are activated during stress, leading to apple-shape obesity and metabolic syndrome. Both the weight gain and metabolic syndrome, however, were prevented by administration of Y2R blocker into the abdominal fat.

“We couldn’t believe such fat remodeling was possible, but the numerous different experiments conducted over four years demonstrated that it is, at least in mice,” said the study’s senior author, Zofia Zukowska, M.D., Ph.D., professor and chair of the Department of Physiology & Biophysics at Georgetown University Medical Center.

“We are hopeful that these findings might eventually lead to control of metabolic syndrome, which is a huge health issue for many Americans,” she said. “Decreasing fat in the abdomen of the mice we studied reduced the fat in their liver and skeletal muscles, and also helped to control insulin resistance, glucose intolerance, blood pressure and inflammation. Blocking Y2R might work the same way in humans, but much study will be needed to prove that.”

More immediately, the findings could provide some comfort to stressed individuals who blame themselves for a weight gain that seems outsized given the food they eat, said Lydia Kuo, a medical student who earned her Ph.D. in physiology due to work on the study.

“This is the first study to show that stress has a direct effect on fat accumulation, body weight and metabolism,” she said. “In humans, this kind of stress-mediated fat gain may have nothing to do with the brain, and is actually just a physiological response of their fat tissue.”

And perhaps the most rapid clinical application of these results will be in both cosmetic and reconstructive plastic surgery, said co-author Stephen Baker, M.D., D.D.S, associate professor of plastic surgery at Georgetown University Hospital. The ability to add fat as a graft would be useful for facial rejuvenation, breast surgery, buttock and lip enhancement, and facial reconstruction, he said, and using injections like those tested in this study could make fat grafts predictable, inexpensive, biocompatible and permanent.

Equally important, blocking Y2R resulted in local elimination of adipose, or fat, tissue, said Baker. “This is the first well-described mechanism found that can effectively eliminate fat without using surgery,” he said. “A safe, effective, non-surgical means to eliminate undesirable body fat would be of great benefit to our patients.”

Roxanne Guy, MD, president of the American Society of Plastic Surgeons, of which Baker is a member, is also excited by the findings, although she agrees that more research is needed to find out how the animal findings translate in humans. “Providing a long lasting, natural wrinkle filler and a scientifically studied, non-surgical method for melting fat could revolutionize ‘growing old gracefully,’” she said. “This discovery could also have positive implications for reconstructive plastic surgery procedures performed on the face and breasts.”

Stress + “comfort” foods = excess weight gain

As part of the study, Zukowska and her team examined the effect of several forms of chronic stress that mice in the wilderness can encounter, such as exposure for an hour a day over a two-week period to standing in a puddle of cold water or to an aggressive alpha mouse, and they conducted the experiments in combination with a regular diet or with a high-fat, high-sugar diet. Stressed animals fed a normal diet did not gain weight, but stressed mice given a high-fat diet did. In fact, the researchers found these mice put on more weight than expected given the calories they were consuming.

“They gained twice as much fat as would be expected, and it was all in their belly area,” Kuo said. Stressed versus non-stressed animals ate the same amount of food, but the stressed animals processed it differently, she said, explaining, “the novel finding here is that NPY works on fat tissue, not in the brain.” This finding makes sense if evolutionary advantage is considered, Zukowska said. “If you can store fat for times of hardship, you have a fat reserve that can be turned into energy for the next fight.

“The same mechanism may be happening in humans,” she said. “An accumulation of chronic stressors, like disagreements with your boss, taking care of a chronically ill child, or repeated traffic road rages, could be acting as an amplifier to a hypercaloric diet when protracted over time. Depression may also be acting as a stressor.” Not only were the stressed mice much fatter, they began to exhibit the metabolic and cardiovascular consequences of obesity, Kuo said. “They had the glucose intolerance seen in diabetes, elevated blood pressure, inflammation in the blood vessels, and fat in their livers and muscles.”

“Although we don’t expect that, in the future, a person will be able to eat everything he or she wants, chase it down with a Y2R blocking agent, and end up looking like a movie star,” said Zukowska, “we are encouraged that these findings could improve human health.”

“The concepts described in this study might give us the tools to design one method to remodel fat and another to tackle obesity and metabolic syndrome,” Baker said. “It is very exciting.”

The study was funded by National Institutes of Health grants awarded to Zofia Zukowska, a Predoctoral Mid-Atlantic Fellowship to Lydia Kuo from the American Heart Association, a contract from the Slovak Research and Development Agency to co-author Richard Kvetnansky, and grants from National Institutes of Health and the Plastic Surgery Educational Foundation awarded to a co-author Stephen B. Baker. Co-authors include Lydia E. Kuo, Ph.D., Joanna B. Kitlinska, Ph.D., Jason U. Tilan, M.S., Lijun Li, M.D., Stephen B. Baker, M.D., DDS, Michael D. Johnson, Ph.D., all from Georgetown University, Edward W. Lee, M.D., PhD, from the University of California-Los Angeles, Mary Susan Burnett, Ph.D., from Washington Hospital Center, Stanley T. Fricke, Ph.D., from Georgetown University, Richard Kvetnansky Ph.D., from Slovak Academy of Sciences, Bratislava, Slovakia, Herbert Herzog, Ph.D. from Garvan Insitute, Sydney, Australia, and Zofia Zukowska, M.D., Ph.D. from Georgetown University.

About Georgetown University Medical Center
Georgetown University Medical Center is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care (through our partnership with MedStar Health). Our mission is carried out with a strong emphasis on public service and a dedication to the Catholic, Jesuit principle of cura personalis -- or "care of the whole person." The Medical Center includes the School of Medicine and the School of Nursing and Health Studies, both nationally ranked, the world-renowned Lombardi Comprehensive Cancer Center and the Biomedical Graduate Research Organization (BGRO).

Biogen Idec and Cardiokine Partner to Develop Lixivaptan, a Novel Vasopressin Antagonist

2007-07-02T12:19:00.000-07:00

Biogen Idec and Cardiokine, Inc., a privately-held specialty pharmaceutical company focused on the development of drugs for the treatment of heart failure and related indications, today announced the signing of an agreement to jointly develop lixivaptan, an oral compound expected to enter a Phase III clinical trial this year for the potential treatment of hyponatremia in patients with congestive heart failure (CHF).

Lixivaptan is a selective V2 vasopressin receptor antagonist that, in clinical trials, has demonstrated promising activity in treating hyponatremia, an imbalance of sodium and water in the body. Lixivaptan works by causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Particularly in heart failure patients, hyponatremia is associated with volume overload, a key symptom leading to hospitalization of these patients. In addition, hyponatremia is an important feature of other disorders including liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH), and can contribute to morbidity and negative outcomes.

“With this late-stage oral compound, we continue to leverage our global development and specialty market expertise to grow our business and broaden our therapeutic focus. An effective treatment for hyponatremia could be beneficial to patients with a variety of diseases, including heart failure,” said James C. Mullen, Biogen Idec’s President and Chief Executive Officer (CEO). “This program will expand our efforts in cardiovascular care and we look forward to working with Cardiokine to deliver this promising new product for patients.”

“We are extremely pleased to be partnering lixivaptan with Biogen Idec. We share an appreciation of the adverse health consequences associated with hyponatremia and have a common vision for lixivaptan. Biogen Idec’s proven development and commercialization capabilities in concert with Cardiokine’s development team will make this vision a reality,” said David Brand, President and CEO of Cardiokine.

Under terms of the agreement, Cardiokine will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan and Cardiokine will have an option for limited co-promotion in the United States (U.S.). The agreement is expected to become effective in the third quarter of 2007, and is subject to the satisfaction of certain closing conditions and customary approvals.

About lixivaptan

Lixivaptan is a highly potent, non-peptide, selective V2 vasopressin receptor antagonist. It antagonizes the action of vasopressin (also known as antidiuretic hormone, ADH) on the V2 receptors in the kidney-collecting duct, causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Based on this mechanism of action, lixivaptan shows promise in the treatment of disease states associated with water retention and electrolyte imbalance.

About hyponatremia

Hyponatremia is the most common electrolyte disorder in clinical practice. It is estimated that the incidence of hyponatremia in hospitalized patients in the U.S. is greater than one million. Hyponatremia is recognized as an independent contributor to negative patient outcomes in many chronic diseases, most notably CHF, as well as cirrhosis and SIADH.

About Cardiokine

Cardiokine, headquartered in Philadelphia, is a privately held specialty pharmaceutical company focused on the development of pharmaceuticals for the treatment and prevention of heart failure and related cardiovascular and metabolic indications. Additional information about Cardiokine is available at www.cardiokine.com

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For press releases and additional information about the company, please visit, www.biogenidec.com

Portola Pharmaceuticals Announces Positive Phase II EXPERT Results

2007-07-02T08:30:00.001-07:00

Portola Pharmaceuticals, Inc. announced today that it will present clinical and preclinical data on its oral Factor Xa inhibitor and on its intravenous and oral ADP receptor antagonist at the XXI Congress of the International Society of Thrombosis and Haemostasis (ISTH) in Geneva, Switzerland on July 6 through July 12, 2007.

The EXPERT poster, which outlines Phase II data on the Company's lead compound PRT054021, is entitled "Evaluation of the Factor Xa (FXA) Inhibitor, PRT054021 (PRT021), against Enoxaparin in Randomized Trial for the Prevention of Venous Thromboembolic Events after Total Knee Replacement (EXPERT)" and will be featured on July 10, 2007 at 5:30 p.m. CEST in the exhibition area.

In addition, Portola will make the following presentations:

"Initial Intravenous Experience with PRT060128 (PRT128), an Orally- Available, Direct-Acting, and Reversible P2Y12 Inhibitor," July 10 at 5:30 p.m. (CEST) in the exhibition area.

"PRT060128, A Novel, Direct-Acting Orally Available P2Y12 Antagonist, Confers Superior Antithrombotic Activity over Clopidogrel in a Mouse Thrombosis Model," July 11 at 10:00 a.m. (CEST) in Room Mont Blanc.

"Differential Effects of Anti-Platelet Drugs on Thrombus Formation and Thrombus Stability," July 11, 2007 at 10:45 a.m. (CEST) in Room Mont Blanc.

"Antagonism of Intrinsic Pathway Inhibits Tissue Factor (TF) -- Initiated Coagulation in a Platelet-Dependent Whole Blood Flow Assay" July 11 at 5:30 p.m. (CEST) in the exhibition area.

"Measurement of Thrombus Stability Predicts Coronary Events Post- Percutaneous Coronary Intervention (PCI)" will be presented on July 11 at 5:30 p.m. (CEST) in the exhibition area.

About PRT054021 -- Portola's Factor Xa Inhibitor

PRT054021 is an oral Factor Xa inhibitor, an anticoagulant initially being studied for the prevention of venous thromboembolism in patients who have undergone orthopedic surgery. Portola expects to develop PRT054021 for additional indications including stroke prevention in patients with atrial fibrillation and secondary prevention of myocardial infarction and stroke. Factor Xa is a validated target (one for which there are approved drugs on the market), and inhibiting its activity is believed to have superior anticoagulant properties compared to other targets such as thrombin. Portola believes its oral Factor Xa inhibitor will offer several advantages, including a long half-life to support once daily dosing and a low peak-to-trough concentration ratio, resulting in consistent activity that does not require monitoring or dose adjustment. In addition, PRT054021 is not excreted in the kidneys and therefore will not require dose adjustment in patients with impaired renal function.

About PRT060128 -- Portola's ADP Receptor Antagonist

PRT060128 is an antiplatelet drug that is the only intravenous (IV) and oral ADP receptor antagonist in clinical development. Portola believes that this compound may provide significant clinical benefit through immediate, high-level platelet inhibition in the acute setting and a seamless transition to predictable, reversible platelet inhibition in the chronic setting. Portola has studied this compound in a robust Phase I clinical development program including single ascending dose and multiple ascending dose studies with the oral formulation and a single ascending dose study with the IV formulation. Based on positive results from these studies, Portola intends to initiate its Phase II program in the second half of 2007.

About Portola Pharmaceuticals, Inc.

Portola Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapeutics for acute and chronic cardiovascular and vascular disease. Portola is currently developing two clinical stage antithrombotics. Portola's lead compound, PRT054021, is an oral Factor Xa inhibitor for the prevention of venous thromboembolism after orthopedic surgery, for stroke prevention in patients with atrial fibrillation and for secondary prevention of myocardial infarction (MI) and stroke. Portola's second compound, PRT060128, is an oral and intravenous ADP receptor antagonist for patients with acute coronary syndrome, for the prevention of cardiovascular events in patients undergoing percutaneous coronary intervention and for secondary prevention of MI and stroke.

The Medicines Company Reacquires Angiox Rights in Europe from Nycomed

2007-07-02T08:28:00.000-07:00

The Medicines Company announced today that it has reacquired all development, commercial and distribution rights for its product Angiox® (bivalirudin) in Europe from Nycomed. Angiox is an anticoagulant used in patients undergoing percutaneous coronary interventions (PCI), commonly referred to as angioplasty. The product is approved in 26 European markets.

The Medicines Company currently sells Angiomax® (bivalirudin) in the United States, which comprises approximately one-third of the worldwide PCI market with approximately one million procedures annually. This transaction gives The Medicines Company a direct presence in European markets where more than one million PCI procedures are performed annually, with an estimated annual growth rate above 10 percent. Another one million PCI patient procedures are performed annually in the rest of the world.

"This is our first step directly into international markets. By selling Angiox ourselves in Europe, where the product's patent extends through mid-2015, we can anticipate product growth well into the next decade," said Clive Meanwell, Chairman and CEO of The Medicines Company. "Establishing operations in Europe also sets up the channel for commercialization of our pipeline of acute care product candidates, including Cleviprex(TM) (clevidipine) and cangrelor. We appreciate the contributions made by Nycomed to the establishment of Angiox in Europe, and we look forward to our collaboration during the transition period."

Under terms of the agreement, The Medicines Company will pay Nycomed:

$20 million today, $5 million upon European health regulators approving an expanded Angiox product label to include findings of the ACUITY trial, and $20 million in 2008. The Medicines Company will assume control of marketing for Angiox and will recognize additional revenue from sales starting July 1. At the same time, the Company will begin to incur operating expenses, including reimbursement of commercial services provided by Nycomed during a transition period. Sales operations will transition to The Medicines Company by the end of 2007, and product distribution will transition during 2008.

"We believe the value proposition for Angiox is universal," said John Kelley, President and COO of The Medicines Company. "Based on results from global clinical studies such as REPLACE-2 and ACUITY, PCI patients throughout the world, including Europe, benefit with improved outcomes and lower costs when heparin is replaced by Angiomax/Angiox. We expect to leverage these advantages using our team's broad and deep experience in global product commercialization."

Last month, the European Society of Cardiology (ESC) published new guidelines on the treatment of acute coronary syndromes (ACS) recommending use of Angiox to replace heparins (unfractionated or low-molecular weight) and platelet GP IIb/IIIa inhibitors in ACS patients undergoing PCI. This builds on earlier ESC guidelines recommending use of Angiox to replace heparins in patients undergoing PCI. An application for marketing authorization is currently under review with European regulatory authorities to expand the approved uses of Angiox to include the emergency use of Angiox in ACS patients undergoing PCI.

"Angiox is a strong product that has enabled Nycomed to create a significant position within the European hospital specialist sector," said Kerstin Valinder, Executive Vice President, Business Development, Nycomed. "We reviewed our product portfolio following the acquisition of ALTANA Pharma and have agreed with The Medicines Company that the timing was appropriate for this transition. Nycomed remains committed to a strategy of strengthening its product pipeline through both in-house research and in-licensing partnerships."

Financial Impact of Transaction

Nycomed will not order additional product during the second half of 2007 under the terms of the agreement. Therefore full-year international revenue guidance for Angiomax/Angiox is lowered from $10 million to $5 to $7 million. Also in 2007, The Medicines Company expects to incur approximately $10 to $12 million in commercial and distribution services paid to Nycomed.

The Medicines Company expects full-year international sales of Angiomax/Angiox in 2008 to be in the range of $15 to $20 million and to have a dilutive impact on after-tax net income of $0.15 to $0.20 per share before amortization of transaction costs.

The Company expects after-tax net income before amortization of transaction costs to be accretive in 2009. The Company expects to incur costs relating to the amortization of the transaction in 2007, 2008, and 2009 that will impact after-tax net income, but is not yet able to estimate the timing or amount of such costs.

By 2011, the Company expects full-year international sales of Angiox to be in the range of $90 to $110 million.

Revenue Guidance

Based upon available hospital discharge data, The Medicines Company estimates a six-percent decline in PCI procedure volume in the United States for 2007 compared to 2006. As a result, the Company is revising its full-year U.S. Angiomax sales guidance to $250 to $260 million from a previously reported $266 to $276 million. Including international revenues noted above, the revised full-year Angiomax sales guidance is $255 to $267 million, compared to a previously reported $276 to $286 million. For the quarter ended June 30, 2007, the Company expects total net revenue to be in the range of $56 to $58 million.

The Medicines Company plans to announce second quarter 2007 financial results later in July. At that time the Company will provide an update on expected 2007 full-year expenses and net income based upon completion of analysis of transaction and transition costs from the Nycomed transaction.

Conference Call

There will be a conference call with management of The Medicines Company today at 9:00 A.M. Eastern Time to discuss the agreement with Nycomed, European expansion plans, financial guidance and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at The Medicines Company website at www.themedicinescompany.com.

The dial in information is listed below:

U.S. Dial In: 800-289-0572

International Dial In: 913-981-5543

Replay is available from noon Eastern Time following the conference call through July 23, 2007. To hear a replay of the call, dial 888-203-1112 (U.S.) and 719-457-0820 (international). The passcode for both dial in numbers is 1262410.

About Angiomax/Angiox

Angiomax/Angiox is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in bleeding complications remain evident even in high-risk patients.

In the United States, Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GPIIb/IIIa inhibition in patients undergoing PCI. Angiomax is also indicated in patients with, or at risk of, HIT/HITTS undergoing PCI. Angiomax is intended for use with aspirin. The most common adverse events for Angiomax in clinical trials comparing Angiomax and heparin were back pain, pain, nausea, headache, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and heparin groups in these trials. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at http://www.angiomax.com

About The Medicines Company

The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin) in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com

Bayer MaterialScience completes Taiwan Ure-Tech acquisition

2007-07-02T03:00:00.000-07:00

Bayer MaterialScience has completed its acquisition of the Taiwan Ure-Tech Group on July 1, 2007. The move has made the company the world’s largest supplier of resins and films. Bayer MaterialScience intends to move the global headquarters of its Thermoplastic Polyurethanes (TPU) Business Unit to Hong Kong by October 1, 2007.

Dr. Tim Bielfeldt, Global Head of the TPU Business Unit, explained: “By joining forces, we are combining the strengths of Ure-Tech as a TPU market leader in Asia Pacific with Bayer’s global competence. As a result, we are now the best-positioned global supplier of TPU resins and films and related solutions. Our goal is to become the number one partner for customers worldwide by delivering excellent service, fast response times and market-focused innovations.”

“The opportunities coming out of this merger are very promising,” commented Frank Huang, formerly CEO of Taiwan Ure-Tech and now a member of the TPU management team. “When you couple the global reputation Bayer MaterialScience has earned through its focus on innovation and quality with our market knowledge, product portfolio and customer focus in Greater China, the result is an exciting future for everyone concerned.”

Integrating Ure-Tech substantially boosts Bayer MaterialScience’s TPU market position in Asia Pacific, significantly expanding the company’s market share in TPU resins in this region. With Ure-Tech’s two TPU production facilities in Asia Pacific added, Bayer MaterialScience will operate eight TPU resin and film production sites around the world. Four of them are located in Asia Pacific – in Taiwan, China, Japan and India. The others are in Europe and North America.

“Moving our global headquarters to Hong Kong highlights the importance of the region,” Bielfeldt adds. “This focus puts Bayer MaterialScience in a solid leadership position, letting us tap into and capture future growth in the world’s largest and fastest expanding TPU market – Greater China.”

In 2006, the total global market for TPU resins and films was estimated to be worth about EUR 1.3 billion. In Asia Pacific, an annual growth rate of roughly 10 percent is assumed for the TPU market.

In 2006, approximately 200 employees of the Ure-Tech Group generated sales of around USD 63 million. Sales of Bayer MaterialScience’s Business Unit Thermoplastic Polyurethanes amounted to EUR 205 million last year with roughly 450 employees. Both parties have agreed not to disclose the purchase price.

About Bayer MaterialScience:
With 2006 sales of 10.2 billion euros (continuing operations), Bayer MaterialScience is among the world’s largest polymer companies. Business activities are focused on the manufacture of high-tech polymer materials and the development of innovative solutions for products used in many areas of daily life. The main segments served are the automotive, electrical and electronics, construction and the sports and leisure industries. At the end of 2006, Bayer MaterialScience had 30 production sites and employed approximately 14,900 people around the globe. Bayer MaterialScience is a Bayer Group company.