Vivus Investors Rejoice as Weight Loss Drug Receives Positive Panel Vote
Today, shares of Vivus (NASDAQ: VVUS) nearly doubled after an FDA panel voted 20-2 to recommend approval of the company's weight loss drug Qnexa. The drug has come a long way from its previous panel appearance, in which the drug suffered a 9-5 vote against recommendation. Obesity affects nearly one-third of Americans, with another one-third being overweight. The large population has prompted at least one Wall Street analyst to predict that the drug would be prescribed to millions, if not tens of millions of people upon approval.
Qnexa has competed against two other weight loss drugs in development from rivals Arena Pharma (NASDAQ: ARNA) and Orexigen Therapeutics (NASDAQ: OREX). Many medical professionals believe that Qnexa has shown the greatest efficacy in clinical trials, with the majority of enrolled patients showing at least a 5% decrease in weight over the life of the study. This fact has convinced the FDA to allow Vivus to conduct a post approval study to determine the severity of potential side effects, such as birth defects and heart conditions, rather than complete a study prior to approval.
A small number of pregnant women within the study gave birth to children with oral clefts. Members of the panel also raised concerns over whether Qnexa patients were more likely to get pregnant than those in the placebo group. While the FDA initially considered barring women of childrearing age from taking Qnexa, it later reconsidered given that Qnexa's primary ingredients are used in a variety of other medications to treat migraines and seizures.
While many medical experts tout a nutritious diet and exercise as the primary way to maintain a healthy weight, many patients suffer from genetic or medical conditions which prevent them from losing significant weight. Obesity can lead to serious conditions such as cancer, diabetes, and heart disease and the FDA panel noted that the side effects of Qnexa could be insignificant given the benefits, as a new weight loss drug has not been marketed since 1999, when Roche unveiled Xenical for obese patients.
Vivus carries the hopes of hundreds of millions of Americans on its back. Obesity is clearly an issue which affects many people, and Qnexa could be the closest thing to a magic pill for those who have trouble losing weight naturally. While analysts have projected a peak of $500 million in yearly sales, those projections could be light if some overweight patients opt to forego traditional weight management strategies and seek the "magic pill" instead.
If you believe that Vivus will be approved and become a blockbuster drug, consider these options:
- Buy shares of Vivus. Despite the near double this morning, many analysts have raised their price targets into the $30-40 range on optimism that the drug will become a major blockbuster.
- Buy shares of competitors Arena Pharma and Orexigen Therapeutics. Both companies shares appreciated on the Vivus optimism and could see further upside if the FDA will accept new NDAs for their drugs.
If you believe that the FDA will continue to question the safety profile of Qnexa and give Vivus a CRL, consider these trades:
- Go short Vivus. While the 20-2 vote is a major vote of confidence, the FDA has gone against panel decisions before. Orexigen received a 13-7 positive vote in 2010 and the FDA issued a CRL.
- Go short Arena or Orexigen. Both companies have not demonstrated the same safety or efficacy profile as Vivus, and their runups could be overdone given that they are not expected to resubmit NDAs for their drugs in the short term.
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