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.