Pharmaceutical News

Greystone Associates news.
Date Posted: 22 September 2009

 (Amherst, NH) – As a group, metered dose inhalers (MDIs) form a strategic part of a healthcare sector that exceeds $20 billion. A closer look at the MDI segment reveals, by drug delivery device standards, a rather complex network of companies and specialty technology firms that form a multilayered technical community, or ecosystem. The relationships between and among members of the MDI ecosystem underlie strategic sourcing and development approaches that can have a significant impact on the timeliness and eventual success levels of the device itself and the drug product it becomes a part of. “Because of the underlying physiology of the human respiratory system, inhaled drug pharmacodynamics, and marked variations in the use of inhalers across patient populations, inhaler design presents unique challenges to device developers,” explains George Perros, Greystone Associates Managing Director. “These complexities are evident in the make-up of the inhaler ecosystem, which encompasses at the highest level particle and aerosol engineering, component and top-level device design and manufacturing, drug and device packaging, validation and testing, and commercialization.” The metered dose inhaler ecosystem includes specialty supplier categories for MDI product elements that are unique to MDIs, such as component design and manufacturing for actuators, valves and canisters. Many of the leading ecosystem companies in this segment have developed or acquired highly specialized technology and engineering skills that can be instrumental in bringing new MDI devices to market on schedule. A new report, researched and prepared by Greystone Associates, examines the MDI ecosystem and its implications on the competitive landscape. The Metered Dose Inhaler Ecosystem – Supply Chains, Strategic Relationships and Sourcing Strategies contains analysis of key supply chain relationships and assesses the importance of strategic sourcing and design partnerships on metered dose inhaler product development cycles. The report also examines and compares the tactical approaches to device development of leading MDI companies and presents market data, forecasts and company profiles. More information is available at www.greystoneassociates.org . About Greystone Greystone Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets. Contact: Mark Smith Voice: 603-595-4340 Fax: 603-804-0466 www.greystoneassociates.org Source: Greystone Associates
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Pfizer news.
Date Posted: 23 September 2009

91-Month Follow-up of the Intergroup Exemestane Study (IES) Demonstrated a Significant Disease-Free Survival (18%) Relative Benefit in Favour of Switching to AROMASIN After 2 to 3 Years of Tamoxifen Compared to Continuing on Tamoxifen for 5 Years in Oestrogen-Receptor Positive/Unknown Postmenopausal Early Breast Cancer Patients Berlin, Germany (September 22, 2009) Pfizer today announced new, longer-term data from the Intergroup Exemestane Study (IES) showing that women who switched to exemestane after taking tamoxifen for two to three years experienced a significant relative reduction (18%) in the risk of disease-free survival (DFS) events* (HR=0.82; 95% CI: 0.73-0.92; P=0.0009), compared to patients who continued on tamoxifen for a full five years of treatment.1 In addition, IES showed that exemestane also prolonged overall survival (OS) in the ER+/unknown population with a 14% relative reduction in the risk of dying (HR=0.86; 95% CI: 0.75-0.99; P=0.04).1 These results demonstrate that the benefits of treatment are maintained in long-term follow-up. These results were presented at the joint ECCO/ESMO meeting in Berlin, Germany.1 “These new, long-term follow-up data of the IES demonstrate a significant survival benefit for patients who switched to exemestane compared to those who stayed on tamoxifen,” said Charles Coombes, head of the oncology department at Imperial College, London, UK and principal investigator of the IES. “These findings are important to patients and physicians alike as they reaffirm their confidence in switching to exemestane after two to three years of tamoxifen.” IES is a landmark trial with the longest follow-up in the switch setting. It is a randomised, double-blind, multinational trial of postmenopausal women with early breast cancer that includes 4,724 patients. IES was designed to compare the efficacy and safety2 of switching patients after two to three years of tamoxifen to exemestane versus continuing on tamoxifen.3 The primary endpoint of the study was DFS in the ITT population. Within the IES, 97% of the study population was oestrogen-receptor positive/unknown.1 In postmenopausal women with early breast cancer at a median follow-up of 91 months, switching to exemestane after two to three years of tamoxifen, for a total of five years of treatment, was shown to result in a: • 16% relative reduction in the risk of DFS events, defined as local or distant recurrence of breast cancer, contralateral breast cancer, or death from any cause, compared to staying on tamoxifen for five years (HR=0.84; 95% CI: 0.75-0.94; P=0.002) in the intent-to-treat (ITT) population.1 • For the secondary endpoint of overall survival in the ITT population, there was an 11% non-significant relative risk reduction of death (P=0.09). There was a statistically significant 14% relative reduction in the risk of death noted in the ER+/unknown population (HR=0.86: 95% CI 0.75-0.94 P=0.04).1 These DFS and OS data are consistent with the previous IES update at 55.7 months. Additionally, exemestane’s safety profile at 91 months was similar to that shown previously with no new serious adverse events in comparison to the previous analysis.1 “These data reconfirm the significant survival advantage that exemestane provides in the management of these women. It is important that women with the disease who are suitable to be switched to exemestane are fully informed of the potential benefits of switch therapy,” said Mr Anthony Skene, Consultant Surgeon at Royal Bournemouth Hospital NHS FT. “Women who have been on tamoxifen for two to three years should ask their healthcare professional if they are on the most appropriate hormone treatment.”  
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Aegate news.
Date Posted: 23 September 2009

Independent research conducted by the Research Centre for Pharmaceutical Care and Pharmaco-economics in Leuven Belgium has shown that drug authentication offers an essential and also cost effective solution to prevent counterfeit medicines from reaching patients.
The increase of fake medicines within Europe is a serious concern. These represent the third largest category of customs seizures in Europe, according to the latest published statistics. The figures show an increase of 57 per cent[1] in the number of cases of counterfeit medicines discovered. Without detection these could lead to harm or even fatalities.   The study, commissioned by patient safety communications company Aegate, demonstrates that a country looking to adopt drug authentication will be taking a significant step further in the battle to protect consumers from counterfeit medicines. Aegate’s working authentication system, which is fully operational in Belgium and Greece and currently being installed in Italy, was rigorously scrutinised as part of the evaluation and demonstrated 100 per cent reliability in identifying authentic, recalled, expired and suspicious drugs at the point of dispense.
In addition, using data models based on a hypothetical, but typical, European country with 10,000 pharmacists, the research illustrates that drug authentication would become cost neutral in a scenario when just a small number of products less than half of one per cent per annum are identified by the pharmacist, using such an authentication system, as unsuitable for dispensing. The modelling shows a potential for health providers to recoup the costs of implementation through healthcare savings, with net gains of up to €28million over a five year period being observed.   [ ] REPORT ON EU CUSTOMS ENFORCEMENT OF INTELLECTUAL PROPERTY RIGHTS. RESULTS AT THE EUROPEAN BORDER – 2008
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Johnson & Johnson news.
Date Posted: 22 September 2009

Irvine, CA (September 21, 2009) Advanced Sterilization Products (ASP) announced today the availability of the STERRAD® 100NX™ System EXPRESS Cycle in the Europe, Middle East and Africa (EMEA) Region. This new, faster cycle is designed for terminal surface sterilization of da Vinci® 3D endoscopes, as well as rigid telescopes, rechargeable batteries and many other devices. The EXPRESS cycle fulfills urgent sterilization needs without the damage associated with other sterilization modalities. The STERRAD® 100NX™ System EXPRESS Cycle is a feature upgrade that customers can choose to add to their new or existing STERRAD® 100NX™ Systems. The 24-minute EXPRESS Cycle joins the 47-minute STANDARD and 42-minute FLEX cycles currently offered on the STERRAD® 100NX™ System for the ultimate in infection prevention options. "The addition of the EXPRESS Cycle and the potential to add other sterilization cycles optimizes our customer's investment in STERRAD® Systems Technology," said Dominique Legros, Vice President of Sales and Marketing for the ASP EMEA Region. "Coupled with ASP first-class technical support and experienced clinical education advisors, the STERRAD® 100NX™ System provides our customers with a long-term and flexible infection prevention solution." The STERRAD® 100NX™ System EXPRESS Cycle is available immediately in the EMEA region. For more information about the EXPRESS Cycle or the STERRAD® 100NX™ System, please contact your local ASP representative.
About STERRAD® Sterilization Systems With thousands of units in use at hospitals and healthcare facilities around the world, STERRAD® Sterilization Systems offer the most productive solution for low-temperature sterilization needs. Engineered using ASP's breakthrough hydrogen peroxide gas plasma technology, STERRAD® Sterilization Systems sterilize instruments and medical devices safely and effectively, without the limitations or risks associated with peracetic acid, steam, and ethylene oxide gas systems. STERRAD® Sterilization Systems produce a measurable return on hospital's sterilization investment by reducing instrument repair costs, offering rapid cycles, reducing instrument inventories, and enhancing safety.
About Advanced Sterilization Products (ASP) Advanced Sterilization Products (ASP) Division of Ethicon, Inc., a Johnson & Johnson company, is a leading developer of innovative instrument sterilization, high level disinfection, and cleaning technologies. The company is dedicated to protecting patients, healthcare workers, and the environment with products that focus as much on safety as they do on efficacy and cost-effectiveness. Utilizing advanced instrument processing technologies, these products help customers to promote positive patient outcomes while controlling costs, increasing productivity, and enhancing safety. The company is based in Irvine, California, USA.
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PHLEXGLOBAL news.
Date Posted: 08 September 2009

7 September 2009 – Phlexglobal, the UK-based specialist support Contract Research Organisation (CRO), has signed a landmark contract with global biopharmaceutical company UCB to implement a complete trial master file management solution. The new contract is worth £12 million, over the next five years, and will see Phlexglobal employ up to 30 new staff. Nicola Murgatroyd, Phlexglobal's founder and chief executive officer, commented: “The UCB contract win is a major achievement for Phlexglobal and will support our rapid expansion, both in the UK and US.” As part of the contract, Phlexglobal will provide electronic and paper trial master file (TMF) management services for UCB global operations. This will include centralising UCB’s historical and ongoing global clinical study files from Phase I through to Phase IV using Phlexglobal’s unique PhlexEview solution. PhlexEview is an end-to-end TMF solution, which allows logical electronic searching and viewing of TMF documentation, once it has been prepared, scanned and indexed into the system. Preparing for archive, TMF QC checking and archive storage completes the management cycle. “Perhaps the most interesting part of the solution is the management insight that will be provided to UCB. PhlexEview allows key users to gain a complete overview of their study documents at any one point in time, this in turn, will provide UCB with business critical information on the status and activity at all study sites. This facility would just not be possible when using paper TMFs and was one of the main influencers in UCB’s decision making process,” continues Nicola. Mark Hill, global head of global trial master file management for UCB added: “We are really excited about working with Phlexglobal and using its unique PhlexEview solution. Online document viewing is a new concept for many of our staff but we believe it is going to make our processes so much quicker and smoother.   “The eight week pilot programme we ran over the summer was a great success and I’m looking forward to building on these positive foundations.” Over the past few years Phlexglobal has increasingly seen significant interest in PhlexEview and its document management services illustrating the changes within the clinical research industry. Nicola added: “With constant pressure to run clinical studies in the most efficient, reliable and cost effective manner, the industry must look for novel approaches to achieve this. UCB has approached this project with both innovation and receptiveness and has enabled the development of a strategic working partnership. This will assist them in responding to industry pressures whilst enhancing the quality and integrity of the TMF.” Based in Amersham, Buckinghamshire, Phlexglobal specialises in flexible staff resourcing, eTMFs, scanning, clinical trial management and support, archiving and training. With 17 of the top 20 global pharmaceutical companies as clients it is committed to achieving high levels of client satisfaction. For further information about Phlexglobal’s services log on to the new website at www.phlexglobal.com.  
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Watson Pharmaceuticals news.
Date Posted: 10 September 2009

MORRISTOWN, NJ, Sep 08, 2009 (MARKETWIRE via COMTEX) Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that Paul Bisaro, Watson's president and chief executive officer, will provide an overview and update of the Company's business at the Bank of America Merrill Lynch Global Healthcare Conference on Tuesday, September 15, 2009 at 2:30 p.m. (BST) (9:30 a.m. EDT). This presentation will be webcast live and can be accessed on Watson Pharmaceuticals' Investor Relations Web site at http://ir.watson.com. The webcast can also be accessed at the following URL: http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=WPI&item_id=2423784. An archived version will be available for 30 days after the live presentation and can be accessed at the same locations. About Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical. For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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Boston Scientific news.
Date Posted: 07 September 2009

 Results of landmark heart failure trial published by New England Journal of Medicine and presented at ESC Natick, MA and Barcelona (September 1, 2009) – Boston Scientific Corporation (NYSE: BSX) today announced final results from the landmark MADIT-CRT trial, which were published by the New England Journal of Medicine and presented during a Hot Line session at the annual European Society of Cardiology (ESC) Congress in Barcelona. Arthur Moss, M.D., Professor of Medicine at the University of Rochester Medical Center and Principal Investigator of the trial, presented the MADIT-CRT data. The primary endpoint showed that Boston Scientific’s cardiac resynchronization therapy defibrillators (CRT-Ds) were associated with a 34 percent relative reduction in the risk of all-cause mortality or first heart failure event in asymptomatic and mild (NYHA Class I and II ) heart failure patients, when compared to standard implantable cardioverter defibrillators (ICDs) (p=0.001). In addition, MADIT-CRT data showed that: • CRT-D therapy reduces the relative risk of heart failure events by 41 percent when compared to ICD therapy (p< 0.001). • Patients treated with CRT-D therapy showed an improvement of 11 percent in Left Ventricular Ejection Fraction after one year, compared to a three percent improvement for ICD patients. “The MADIT-CRT Executive Committee anticipated that the benefit for the CRT-D therapy group would be dominated by a reduction in heart failure events and the data overwhelmingly confirm that,” said Dr. Moss. “Furthermore, CRT-D therapy showed an equal benefit in both ischemic and non-ischemic patients. The MADIT-CRT data are compelling and help bridge a clinical gap in our understanding of heart failure in Class I and II patients.” “The publication of the manuscript by the New England Journal of Medicine and the presentation of MADIT-CRT data at ESC highlight the importance of this study, which clearly demonstrates that CRT-D therapy slows the progression of heart failure, further delaying the onset of more severe and life-limiting conditions,” said Fred Colen, President, Boston Scientific Cardiac Rhythm Management. “We look forward to working with the FDA as we seek approval for an expanded indication for our CRT-D devices, based on these strong results.” MADIT-CRT is the world’s largest randomized study of NYHA Class I and II patients, with more than 1,800 patients enrolled at 110 centers in 14 countries. Approximately 60 percent* of all heart failure patients in the European Union fall into Class I or II. Nearly 22 million people worldwide currently suffer from some form of heart failure. MADIT-CRT is an important continuation of Boston Scientific’s exclusive sponsorship of landmark clinical trials that have broken new ground and helped improve outcomes for high-risk cardiac patients worldwide. Most of the patients who receive an ICD or CRT-D were first indicated for this life-saving therapy through clinical research sponsored by Boston Scientific or its predecessors. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our product performance, clinical outcomes, regulatory approval of our products, and our growth strategy. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: fu…
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Johnson & Johnson news.
Date Posted: 10 September 2009

An ADHD Resource in the Palm of Your Hand Text “ADHD” to 87415: Symptom Screeners, Disease Information, Videos and Toll-Free Call Center Titusville, NJ (Sept. 9, 2009) — Attention Deficit Hyperactivity Disorder (ADHD) is estimated to impact up to 20 percent of children1 and 4 percent of adults in the U.S.2 Recent studies suggest ADHD is underdiagnosed: researchers estimate up to 20 percent of U.S. school-aged children meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, but only 7.8 percent report receiving an ADHD diagnosis.3 Meanwhile, it is estimated that just 15 percent of U.S. adults with ADHD have been diagnosed with the condition.2 To help elevate understanding of this condition, in the past several years the U.S. ADHD community has targeted September as a month of national recognition for ADHD awareness. In anticipation, McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and makers of CONCERTA® (methylphenidate HCI), approved for treatment of ADHD in children and adults, is providing an innovative resource for information on ADHD and treatment: the CONCERTA® Mobile Web. By texting “ADHD” to 87415 on any mobile device—such as a cell phone, smartphone, personal digital assistant (PDA) or handheld computer—consumers can access the CONCERTA® Mobile Web. The resource includes background on ADHD in children and adults, an interactive symptom screener from the World Health Organization (WHO), video testimonials from families impacted by ADHD, information on CONCERTA® treatment as well as a CONCERTA® coupon offer. The CONCERTA® Mobile Web also offers one-click convenience to speak with trained professionals about general ADHD and treatment questions at the CONCERTA® ADHD Support Center (also available by calling 1-877-324-ADHD). This new resource is timely, given that according to a recent comScore, Inc. report, the number of people in the U.S. using their mobile device to access news and information on the Internet more than doubled between January 2008 and January 2009. Among the audience of 63.2 million people who accessed news and information on their mobile devices in January 2009, 22.4 million (35 percent) did so daily; more than double the size of the audience last year. “We know consumers are turning to mobile technology more and more for information, and CONCERTA® is excited to be there with them, especially to provide information on ADHD and our product,” said Lars Merk, CONCERTA® product director at McNeil Pediatrics™. “The CONCERTA® Mobile Web speaks to both increasing awareness of ADHD and awareness of what consumers want when using technology. We’re continually looking for new ways of making therapeutic and product information more accessible to them.” Merk noted that the content is mobile-formatted versions of some of the most popular features on McNeil Pediatrics’™ CONCERTA® product Web site, http://www.concerta.net. “As the market leader in pediatric treatment of ADHD, CONCERTA® is committed to being a partner for caregivers of children with this condition, especially in the fall as children head back to school —and we hope the CONCERTA® Mobile Web can be a new, user-friendly resource for both caregivers and adults with ADHD.”
About ADHD Attention Deficit Hyperactivity Disorder (ADHD) is a common and treatable medical condition characterized by inattention, hyperactivity and impulsivity that is estimated to affect about 5 million children and 8 million adults in the U.S. Among other symptoms, a person with ADHD may have trouble sitting still, finishing tasks or following directions. While the exact cause of the condition is still unknown, scientists have focused their research on chemical messengers, or neurotransmitters, in the brain. These messengers are believed to play a role in behaviors like attention and movement. Much like height or eye color, ADHD can be inherited. Studies suggest that 76 percent of ADHD is linked to family genetics. So the condition is more common among people who have a close relative with ADHD. Adults with ADHD have a 50 percent chance of passing it on to their children.
About CONCERTA® CONCERTA® is a prescription product approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.
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Roche news.
Date Posted: 09 September 2009

William M. Burns, Juergen Schwiezer and Jonathan Knowles to retire – Pascal Soriot appointed COO Pharma Division and Daniel O’Day appointed COO Diagnostics Division – Jean-Jacques Garaud and Dan Zabrowski to become Members of Enlarged Executive Committee – Ian Clark appointed CEO Genentech At the end of 2009 William M. Burns (62), CEO Pharma Division, Juergen Schwiezer (65), CEO Diagnostics Division, and Jonathan Knowles (62), Head Group Research, will resign from the Corporate Executive Committee. Juergen Schwiezer and Jonathan Knowles will retire, while William M. Burns, as announced previously, will be proposed as a Member of the Roche Board at the Annual Shareholder Meeting 2010. William M. Burns started his career in 1986 with Roche UK. He has been a Member of the Corporate Executive Committee for ten years, thereof eight years as Head Pharma Division. Juergen Schwiezer joined Boehringer Mannheim in 1976 and was appointed Head of its Executive Committee in 1995. He became a Member of the Executive Committee Roche Germany in 1998 and was heading the Diagnostics Division as Member of the Roche Corporate Executive Committee since 2008. Prof. Jonathan Knowles was appointed Head Roche Research in 1997 and has been a Member of the Corporate Executive Committee since 1998. Franz B. Humer, Chairman of the Roche Group, said: „William M. Burns, Jonathan Knowles and Juergen Schwiezer have significantly shaped Roche’s successful development over many years. All three have been instrumental in driving the Group’s overall success. We are deeply grateful for their tremendous contribution throughout their distinguished careers.” The Board of Directors has made the following appointments, effective 1 January 2010: Pascal Soriot (50), currently CEO Genentech and Member of the Corporate Executive Committee, is appointed Chief Operating Officer (COO) Pharma Division and assumes global responsibility for Pharma operations. These include commercial operations worldwide, global marketing, production, development and registration. Jean-Jacques Garaud (54), currently Head Pharma Development, is appointed Member of the Enlarged Executive Committee and assumes responsibility for Roche Pharma Research and Early Development. Dan Zabrowski (50), Head Pharma Partnering, is also appointed Member of the Enlarged Executive Committee. As announced previously, Richard Scheller is a Member of the Enlarged Executive Committee. Based in San Francisco, he is responsible for Genentech Research and Early Development, which is managed as an independent unit. Jean-Jacques Garaud, Richard Scheller and Dan Zabrowski report to Severin Schwan. Daniel O’Day (45), currently Head Roche Molecular Diagnostics, is appointed Chief Operating Officer (COO) Diagnostics Division and Member of the Executive Committee. Burkhard Piper, Head Roche Diabetes Care, reports to Daniel O’Day. Ian Clark (49), currently Head Global Product Strategy Pharma, will succeed Pascal Soriot as CEO Genentech. He will report to Pascal Soriot and will be based in South San Francisco. Franz B. Humer, Chairman of the Roche Group commented: „We are proud to complement the Corporate Executive Committee with internal appointments having such an impressive track record. With this strong leadership team Roche will continue to be successful in the years ahead!” Severin Schwan, CEO of the Roche Group, said: „Following the conclusion of the Genentech integration we will continue to bring innovative healthcare solutions to patients worldwide through a diversity of research approaches and through efficient global development and commercialization. This broadened and younger Corporate Executive Committee will continue to drive Roche’s long-term vision as the world’s leading biotech company.“ Effective 1 January 2010 Roche’s Corporate Executive Committee (CEC) will be composed as follows:   Severin Schwan- Chief Executive Officer Erich Hunziker- Chief Financial Officer and Deputy Head of the CEC Pascal Soriot- COO Pharma Division Daniel O’Day- COO Diagnostics Division Silvia Ayyoubi- Head Human Resources Gottlieb Keller -General Counsel
Jean-Jacques Garaud*- Head Roche Pharma Research & Early Development Richard Scheller*- Head Genentech Research & Early Development Dan Zabrowski* -Head Pharma Partnering Osamu Nagayama*- President and CEO Chugai Pharma Per-Olof Attinger* -Head Communications
* Member of the Enlarged Corporate Executive Committee
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GlaxoSmithKline news.
Date Posted: 10 September 2009

Philadelphia, September 9, 2009 – GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX®, the company’s candidate cervical cancer vaccine (12-1 and 11-1, respectively). CERVARIX was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer.The committee also discussed data demonstrating the efficacy of CERVARIX against additional cancer-causing virus types. “This is an important step in cancer prevention for the millions of girls and young women at risk for cervical cancer,” said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. “If approved, CERVARIX will provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year.” The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine. If approved, the FDA will determine final prescribing information. In clinical trials, the most common side effects after vaccination with CERVARIX included pain, redness and swelling, fatigue, headache, joint and muscle aching, gastrointestinal symptoms and fever. Serious adverse events were generally comparable between the groups receiving CERVARIX and the control groups. In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 females, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women. About CERVARIX® GSK designed CERVARIX with its ASO4 adjuvant system to deliver high and sustained levels of antibodies aimed at providing long-term protection against cancer-causing HPV types, although the exact level of antibodies that confer protection is not known. Protection has been shown through 6.4 years and ongoing clinical studies continue to assess duration of protection. ASO4 enhances the body’s immune response to the antigens contained in the vaccine. This response provides protection at the cervix, where natural protection may not adequately protect against future infections with the same virus type. To date, CERVARIX has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009. CERVARIX® (Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) is a registered trademark of the GlaxoSmithKline group of companies.
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