VIVUS, Inc. VVUS (Related) , 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(TM) 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.
"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.
About Qnexa
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.
About VIVUS
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(TM), for which a Phase 2 study has been completed for the
treatment of obesity; Testosterone MDTS(R), for which a Phase 2 study
has been completed for the treatment of Hypoactive Sexual Desire
Disorder (HSDD); EvaMist(TM), 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(R) 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.
Contact Information: VIVUS, Inc.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
or
The Trout Group
Ian Clements, (SF) 415-392-3385
Brian Korb, (NYC) 646-378-2923
Copyright 2007 BusinessWire
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