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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About the CYPHER®Stent

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

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

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

About Cordis Corporation

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

Vanda Pharmaceuticals Hires Chief Commercial Officer Al Gianchetti

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

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

About Vanda Pharmaceuticals Inc.

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

Invitrogen and HUPO Announce New Standard for Mass Spectrometry

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

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

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

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

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

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

About Invitrogen

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

About HUPO

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

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

Genetic Immunity Closes $2 Million Dollar Bridge Financing

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

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

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

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

About Genetic Immunity

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

About Rodman & Renshaw

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

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

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

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

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

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

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

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

About Invitrogen

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

About Natural Selection, Inc.

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

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

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

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

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

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


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



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

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


About Orlistat

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

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


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


The overweight and obese population in Europe


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


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


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


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






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



About GSK

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

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

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

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

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

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

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

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

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

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

About GE Global Research

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

About GE Healthcare

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

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

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

About Lilly

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