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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.