VIVUS Announces Formation of Qnexa Scientific Advisory Board
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced the formation of its Qnexa™ Scientific Advisory Board (the “Qnexa SAB”), consisting of six well known experts in the areas of obesity, trial design, psychology and diabetes. The company has appointed Dr. David Allison, Dr. Nancy Bohannon, Dr. Arthur Frank, Dr. Donna Ryan, Dr. Xavier Pi-Sunyer and Dr. Tom Wadden to the Qnexa SAB. These experts will provide guidance concerning upcoming Qnexa phase 3 clinical trials.
“The Advisory Board is enthusiastically anticipating its role in guiding VIVUS in the development of Qnexa.”
“It’s important to have the highest caliber experts available to help guide our Qnexa clinical development program,” said Leland F. Wilson, president and CEO of VIVUS. “The unparalleled experience of this group will help ensure that VIVUS has the best clinical development plan possible.”
“Qnexa is potentially a significant scientific and clinical advancement and it is our privilege to participate in this Scientific Advisory Board,” said Dr. Arthur Frank, chairman of the Qnexa SAB. “The Advisory Board is enthusiastically anticipating its role in guiding VIVUS in the development of Qnexa.”
Members of the Qnexa SAB are as follows:
Dr. David Allison
David B. Allison received his Ph.D. from Hofstra University in 1990. Dr. Allison completed a post-doctoral fellowship at the Johns Hopkins University School of Medicine and a second post-doctoral fellowship at the NIH-funded New York Obesity Research Center at St. Luke's/Roosevelt Hospital Center. Dr. Allison was a research scientist at the NY Obesity Research Center and Associate Professor of Medical Psychology at Columbia University College of Physicians and Surgeons until 2001. In 2001, Dr. Allison joined the faculty of the University of Alabama at Birmingham, where he is currently Professor of Biostatistics, Head of the Section on Statistical Genetics, and Director of the NIH-funded Clinical Nutrition Research Center.
Dr. Allison has authored over 300 scientific publications and edited five books. He has won several awards, including the 2002 Lilly Scientific Achievement Award from the North American Association for the Study of Obesity and the 2002 Andre Mayer Award from the International Association for the Study of Obesity and has been elected as a Fellow of the American Statistical Association. He holds several NIH and NSF grants and has been a member of the Board of Trustees for the International Life Science Institute, North America, since January 2002. He has been elected to the vice presidency of NAASO: The Obesity Society, North America's largest and most prestigious academic society concerned with obesity, and will become president-elect in October 2007 and president in October 2009.
Dr. Nancy Bohannon
Nancy J.V. Bohannon, M.D., completed the Dorothy Frank Diabetes clinical research fellowship at UCSF, sponsored by the San Francisco Diabetes Association, prior to becoming an assistant clinical professor at UCSF. She has been a principal investigator on over 70 clinical trials, involving devices and drugs for diabetes, hypertension, obesity and dyslipidemia. Currently, Dr. Bohannon is Director of Clinical Research at the Cardiovascular Risk Reduction Program at St. Luke's Hospital in San Francisco, California. She continues her full time solo private practice specializing in research in and treatment of diabetes and metabolic disorders in San Francisco, where she has practiced for 30 years. Dr. Bohannon is on the editorial boards of Insulin, diatribe, Diabetes Forecast, Diabetes Health and others and is a reviewer for Diabetes Care, Clinician Review, Expert Review of Medical Devices, Endocrine Practice, Diabetes and its Complications, Expert Opinion of Drug Delivery, and Expert Opinion on Pharmacotherapy. She has published over 70 articles.
Dr. Arthur Frank
Arthur Frank, M.D., has served as the medical director of The George Washington University Weight Management Program since 1991. A specialist in internal medicine, Dr. Frank has concentrated his professional activities on the medical management of adult obesity, the medical management of adult obesity, the development of related public policy, and the formulation and implementation of a variety of clinical trials studying the problems of weight management and obesity.
Dr. Frank’s practice is directed to the issues of human nutrition and the metabolic and psychological factors affecting obesity. He supervises a staff of nutritionists, psychologists, exercise therapists and physicians who work intensively in a multidisciplinary approach to the medical, behavioral and physiologic components of this chronic disease.
Dr. Frank has worked with the Office of Economic Opportunity and the Department of Health, Education and Welfare. A graduate of The Massachusetts Institute of Technology and of the New York University School of Medicine, Dr. Frank completed his residency in internal medicine at the Stanford Medical Center where he was also a research fellow in endocrinology and metabolism. Subsequently, he was a research fellow at the National Heart Institute in Bethesda, Maryland.
Dr. Donna Ryan
Donna Ryan is a Professor and Associate Executive Director for Clinical Research at the Pennington Biomedical Research Center in Baton Rouge, Louisiana.
Dr. Ryan received her medical degree from LSU School of Medicine. She is board certified in internal medicine and medical oncology. For the past 19 years she has focused on obesity and nutrition and her research interests include many aspects of obesity management and prevention. She is Principal Investigator of a U.S. Army Military Nutrition Research grant, Co-PI for the Pennington Clinical Nutrition Research Center and Co-PI for the NIDDK Look AHEAD study that addresses weight loss in persons with type 2 diabetes. She is also Co-PI for the NHLBI-funded POUNDS LOST study evaluating four diets of differing macronutrient composition. Her most recent research interest has been practical (or pragmatic) clinical trials to evaluate weight loss in routine medical practice, and she has one study funded by the state insurance company for Louisiana that is ongoing.
Dr. Ryan is the author of over 100 articles on obesity. She is also interested in training primary care physicians to effectively manage obesity and is a frequent participant in continuing education programs targeting improvement of health professionals’ skills in obesity management.
Dr. Xavier Pi-Sunyer
F. Xavier Pi-Sunyer, M.D., MPH is Professor of Medicine at Columbia University College of Physicians and Surgeons in New York City. At St. Luke's-Roosevelt Hospital Center he serves as Chief of Endocrinology, Diabetes, and Nutrition, and is Director of the New York Obesity Research Center. Dr. Pi-Sunyer is also a Senior Attending Physician at St. Luke's-Roosevelt Hospital and New York-Presbyterian Hospital.
He recently chaired the committee of the National Heart, Lung, and Blood Institute that researched and defined the federal government's new guidelines for the prevention and treatment of obesity. He has served as president of the American Diabetes Association, the American Society for Clinical Nutrition, and the North American Association for the Study of Obesity. He has been a Fellow of the Fogarty International Center of the National Institutes of Health, a member of the Institute of Medicine's Task Forces on Medical Nutrition Therapy and on Dietary Reference Intakes on Macronutrients. He served on the 2005 U.S. Dietary Guidelines Advisory Committee. He is currently a member of the FDA Science Board Advisory Committee.
Dr. Pi-Sunyer has been a member of the American Diabetes Association for over 25 years and served as President (1992-1993) and chaired numerous committees at the national, regional, and local levels. In 1993 he was awarded the Banting Medal for Service from the Association. He has also served in numerous committees for the American Heart Association, as a member of the Council and Executive Committee of the Council on Nutrition and Physical Activity, and as chair of the Obesity Committee.
Dr. Pi-Sunyer has written over 300 articles for international peer-reviewed journals and the lay press and has contributed chapters to over 100 medical texts. From 1994 to 2005, he served as the Associate Editor for the International Journal of Obesity, and from 1995 and 2000 served as editor-in-chief of Obesity Research. He also is a Journal Referee for 20 other professional journals.
Dr. Tom Wadden
Thomas A. Wadden, Ph.D. is Professor of Psychology in Psychiatry at the University of Pennsylvania School of Medicine and Director of the Center for Weight and Eating Disorders. He received his A.B. in 1975 from Brown University and his doctorate in clinical psychology in 1981 from the University of North Carolina at Chapel Hill.
Dr. Wadden's principal research is on the treatment of obesity by methods that have included lifestyle modification, very-low-calorie diets, exercise, medication, and surgery. He has also investigated the metabolic and psychosocial consequences of obesity and weight loss. He has published over 250 scientific papers and book chapters and has co-edited four books.
Dr. Wadden serves on NIH's Clinical Obesity Research Program (CORP) and on the editorial boards of International Journal of Eating Disorders, Journal of Consulting and Clinical Psychology, and Obesity Research. He served as President of the North American Association for the Study of Obesity (NAASO) in 2006 and is now its Immediate Past President.
Qnexa is a proprietary pharmaceutical treatment that incorporates low doses of active ingredients from two previously approved products (phentermine and topiramate). By combining the activity of each of these compounds, Qnexa simultaneously addresses excessive appetite and high threshold for satiety, the two main mechanisms that impact eating behavior. We believe Qnexa is the first product to treat obesity in this manner. Qnexa is subject to U.S. and International patents.
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. VIVUS has three products that are positioned to enter Phase 3 clinical trials, and one product currently under NDA review by the FDA. The pipeline includes: Qnexa™, for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS®, for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist™, for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; and avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE® is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that the EvaMist NDA submission will be approved in a timely basis, or at all. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS' Form 10- K for the year ended December 31, 2006 and periodic reports filed with the Securities and Exchange Commission.