MOUNTAIN VIEW, Calif., Sept. 22, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) reported that in the opening keynote address at the 6th Annual Obesity and Wellness Congress in Washington DC today, Kenneth E. Thorpe, PhD stated that 10% weight loss in patients age 60 to 64 may be able to provide Medicare savings of $8 billion over ten years and $35 billion over their lifetime.
The meeting included Chief Medical Officers of Health Plans, Payers, Health Systems and Hospitals as well as large Employers' Benefits and Wellness Directors. Topics included public policy and the obesity epidemic, preventive programs, and how medical weight loss leads to a reversal of chronic conditions and savings for stakeholders.
Dr. Thorpe is a professor and Chair of health policy and management at the Emory Rollins School of Public Health. He also serves as Executive Director of the Partnership to Fight Chronic Diseases and as a consultant to VIVUS. Dr. Thorpe's most recent publication in the September 8th issue of Health Affairs reflected the finding that the U.S. government could save billions of dollars over the lifetimes of Medicare enrollees by investing in weight loss methods to help prevent diabetes or heart disease.
Dr. Thorpe said that many of the government's current approaches to weight loss are not addressing the present obesity epidemic that is responsible for the rising rates of diabetes, hypertension and dyslipdemia. Dr. Thorpe explained that emerging obesity treatment options could potentially reduce the medical costs associated with obesity and related co-morbidities.
Many overweight and obese adults are pre-diabetic (which occurs when blood glucose levels are higher than normal but not yet high enough to be diagnosed as type 2 diabetes), have hypertension or high cholesterol. These people face a higher risk of suffering from heart disease in the future.
Dr. Thorpe said, "Medical treatments producing a 10% weight loss in patients with existing co-morbidities could be extremely useful in generating Medicare savings in the billions. Obesity is a national epidemic with few useful treatment options. I am hopeful that new therapies will continue to be developed at a time when members of Congress are looking for Medicare spend reductions with aging baby boomers."
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit 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," "estimate" and "intend," among others. 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, the timing and substance of our response to the FDA's requests from the End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA's CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy or FORTRESS; the FDA's interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA's interpretation of the data from our SEQUEL study, or OB-305; the FDA's requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA's CRL or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA's safety concerns, that the FDA will not require us to conduct any additional prospective studies or retrospective observational studies, 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 statements. Investors should read the risk factors set forth in VIVUS' Form 10-K for the year ending December 31, 2010, and periodic reports filed with the Securities and Exchange Commission.
Investor Relations: The Trout Group
Timothy E. Morris
Chief Financial Officer
SOURCE VIVUS, Inc.