VIVUS pointing to findings involving weight loss and big Medicare savings - BioMedReports (subscription)

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fda calendarVIVUS, Inc. (NASDAQ:VVUS) is pointing investors to statements made in the opening keynote address at the 6th Annual Obesity and Wellness Congress in Washington DC. There, 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."

VVUS shares have been trading down towards some support at the $8.50 level during the past five sessions. If that level is broke, shares could find some minor support at the $8.00 mark, but much stronger support at the $7.76 level. On Sept 16trh, shares opened higher after the drug developer laid out plans to resubmit a diet pill for review by the end of next month. That means the Food and Drug Administration could make a decision on the drug by the second quarter next year. The Mountain View, Calif., company said its agreement with the FDA allows it to seek approval for Qnexa as a treatment for patients that include obese men and women of "non-child bearing potential."

Arena (NASDAQ:ARNA), Orexigen (NYSE:OREX) and Vivus have all been making news with their obesity drugs in recent days.

Orexigen Therapeutics shares have been rising after that frim announced that it was reviving development of its experimental obesity drug, Contrave, after receiving a letter from the F.D.A. outlining the design of a clinical trial that could lead to the drug's approval as early as 2014. Contrave was the third of three new obesity pills to be rejected in rapid order by the agency, prompting some researchers, advocates and investors to complain that it was setting an unreasonably high safety bar even as obesity had become a huge public health problem.

Earlier this month, the Senate Appropriations Committee expressed its concern about the absence of novel medicines to treat obesity, the second leading cause of preventable deaths in the United States. It instructed the F.D.A. to report by the end of next March on the steps it would take to support the development of new treatments for obesity.

Qnexa® is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.

As we look at the BioMedReports FDA and Worldwide Regulatory Calendar we see three upcoming upcoming milestones for the stock including one involving the European Medicine Agency's review of Qnexa. If approved, Qnexa® for the treatment of obesity could receive marketing authorization in all 27 EU member countries.

22 Sep, 2011

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