One of the most closely watched competitions in biotechnology involves the final sprint toward marketing approval by Orexigen Therapeutics, Vivus and Arena Pharmaceuticals, each of which is at work on a new obesity drug. And New York Times scribe Andrew Pollack says that the investment community and physicians appear to give Vivus the edge for the single compound most likely to grab the biggest market share. Vivus shares are up 90 percent this year.
Vivus has been studying Qnexa, which was credited with triggering a 10 percent and 11 percent weight loss among patients taking a high dose of the drug. That compares with a two percent weight loss in the placebo arm of the trial. Orexigen's Contrave registered a placebo-adjusted weight loss of 3.2 percent to 3.5 percent, while Arena's Lorcaserin came in at 3.1 percent and 3.6 percent.
But Qnexa mixes phentermine and topiramate, a generic epilepsy drug which has been known to leave patients befuddled. And some doctors, writes Pollack, have begun to prescribe the two drugs separately, which could erode sales of the new therapy. Orexigen also combines two generics, including the well known antidepressant bupropion. Only Arena's Lorcaserin is a new drug.
But a history of serious side effects from earlier therapies is likely to leave the FDA cautious as it considers an approval for each in coming months. Diet drugs can register enormous sales, but they aren't always used by the right patients. "I think what the FDA is going to be paranoid about is a non-obese person who wants to drop 5 or 10 pounds in front of a wedding or a reunion," says Cory Kasimov, an analyst at JPMorgan.
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