written by EXPstocktrader, a noted biotechnology stock trader and former Wall Street executive
VIVUS, NASDAQ: VVUS, 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. The market for prescription weight loss pharmacotherapy is estimated to be $5 billion by 2015. The potential for new prescription drugs to treat obesity and maintain weight loss is enormous to say the least. In the US, about $60 billion is spent every year on weight loss products including multiple diet programs, dietary foods and beverages, OTC supplements, appetite suppressants, gym memberships, videos, books, exercise equipment, and even bariatric surgery. There is currently one FDA approved drug for weight loss Xenical (orlistat), but unpleasant GI side effects has resulted in very low popularity.
Qnexa may have the potential, if approved, to garner the lion's share of this market. The weight-loss drug Qnexa, was rejected by the FDA in October, 2010. 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.
Qnexa was developed by Dr. Thomas Najarian, the inventor of Qnexa who opened a weight-loss clinic in 2001 and has seen great success by engaging through a regulatory loophole of sorts, whereby many obesity doctors prescribe the two already approved separate drugs that make up Qnexa . When taken together, they are essentially the same medicine. So, the combination of these two existing drugs, phentermine, an appetite suppresor, and topiramate, a drug typically used for epilepsy and migraines is currently found to be working, and has done so for several years . Some doctors believe the component drugs are very effective at managing obesity, and the two drugs can be prescribed separately to patients under this loophole despite the dangers sited by the FDA.
However, the FDA is concerned about the documented side effects of Qnexa, and as a result, the FDA may require a large new clinical trial to reassess if Qnexa increases the risk of heart attacks. This approval requirement, if implemented, would delay FDA approval on the drug once again.
Mountain View, California, Oct. 17, 2011 - VIVUS, Inc. announced that the company has resubmitted the New Drug Application (NDA) for Qnexa® (diet drug) to the U.S. Food and Drug Administration (FDA). The resubmission follows an agreement reached in September 2011 with officials of the Endocrine and Metabolic Division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI > 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication (Not to be used) for women of childbearing potential (WOCBP). The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
After further discussion with the agency, FDA has asked and VIVUS agreed to remove the contraindication for WOCBP because a contraindication typically indicates that a drug should not be used in that population because of the risk of use clearly outweighs any possible therapeutic benefit. In addition, FDA asked that VIVUS include less restrictive elements in its REMS program that focus on patient and physician educational measures because it was concerned that more restrictive measures may result in greater off-label use of currently marketed topiramate and phentermine products to treat obesity in WOCBP without the benefit of an appropriate risk mitigation program. In response to these concerns, VIVUS removed the contraindication in WOCBP and modified its risk mitigation strategy.
Documents posted online last Friday, showed that the FDA reiterated concerns about two safety issues that plagued the pill the time first around: Potential heart problems and birth defects in women who become pregnant while taking the drug. On Wednesday the FDA will ask experts at a public meeting to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss blood pressure and higher heart details reported from patients taking the drug.
Utimately, the panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision during April 2012.
Medical Need Sited
Results from the 2007-2008 National Health and Nutrition Examination Survey indicate that approximately 68% of adults in the United States are obese or overweight (Flegal 2010). Obesity is associated with numerous co-morbidities, including dyslipidemia, coronary artery disease, hypertension, stroke, cancer, and type 2 diabetes (Must 1999; Poirier 2006). Epidemiological data indicate obesity and excess weight as factors associated with an increased risk of premature death (Adams 2006; Katzmarzyk 2003). Recent data suggest that current increases in obesity rates could continue. At present, the only effective treatment for obesity is bariatric surgery; however, this approach has been reported to have significant complications.
Within 5 years Qnexa could attain a significant share or the greatly enhances obesity market due to its efficacay and flexible dosing options, which could fit a wide variety of patient profiles.
Qnexa is expected to replace current available agents and expand the weight management category to patients not currently receiving pharmacotherapy. Also, the drug would be heavily marketed to primary care physicians who currently account for about 90% of the current weight loss prescriptions, as well as, they would be seeking a global partner.
1) Heart rate issues
2) Blood Pressure issues
3) Birth defects with WOCBP/teratogenicity is not unique for Qnexa - so strong REMS and labeling should satisfy the FDA. WOCBP - just exclude them.
Investors placing their bets on approval sited here:
SC 13G VIVUS INC (ORBIMED ADVISORS LLC) 02/14/12
SC 13G VIVUS INC(QVT FINANCIAL LP) 09/02/11
SC 13G VIVUS INC(SUTTONBROOK CAPITAL MANAGEMENT LP) 03/09/11
SC 13G VIVUS INC(FIRST MANHATTAN CO) 02/15/11
SC 13G VIVUS INC(CITADEL ADVISORS LLC) 02/04/11
SC 13G VIVUS INC(BLACKROCK INC.) 01/29/10
SC 13G VIVUS INC(FMR LLC) 2/17/09
BofA/Merrill has increased expectations of a positive recommendation of VIVUS's Qnexa following a review of the FDA's briefing documents. Shares are Buy rated with a $16 price target.
Lastly, it is reported that Qnexa exceeds the FDA's minimum effictiveness requirement, but the real question is whether or not the new safety date presented will sway the new FDA panel? This year there are 22 panel members scheduled to vote. FDA advisors meet this coming Wednesday, however the final approval to approve the Qnexa weight loss drug, the first new prescription diet pill in 13 years, is slated for April 2012.
Disclosure: I am long VVUS.