Fat Thursday For Vivus
Vivusannounced this morning that an FDA advisory committee is tentatively scheduled to take a look at its diet drug Qnexa on Thursday, July 15th. If the outside panel of experts gives the weightloss pill thumbs up then the company expects the agency to make a decision on whether to approve it on or before October 28th.
But Leerink Swann analyst Steve Yoo thinks that Vivus and Arena could have a double-date on the 15th of July. Although Arena hasn't made an announcement yet, Yoo is telling clients in a research note that because the two companies filed for FDA approval of their diet pills within days of each other, that they'll probably both get their drugs reviewed by an advisory committee at the same time. Orexigen , the remaining little biopharma company with an obesity fighter in late-stage development, says it plans to file for approval of its drug Contrave by the end of next month.
The FDA usually, but not always, follows the advice of its outside panels. And with diet drugs, in particular, the agency is, no doubt, going to apply extra scrutiny. There's the fen-phen diet drug craze of the 90s that led to some people having heart trouble. The pill ended up being pulled off the market and Wyeth had to pay billions of dollars in damages. Then, a few years ago Sanofi-Aventis had a drug called Zimulti that some analysts were saying was going to be a mega-blockbuster wonder pill. But an advisory committee killed it over concerns about psychiatric side effects.
That kind of uncertainty is why many believe that potential corporate partners for VVUS, ARNA and OREX are going to wait to see if the companies can clear this huge regulatory hurdle before handing over any cash. Again, these are small companies and so if or when their drugs get approved, they're likely going to need the help of a much bigger company's sales force to market them. And, of course, there's always the possibility that one, two or all three of them just get bought.
July is shaping up to be a big month for regulatory action in biopharma. In addition to the Qnexa meeting, the FDA had already announced it's going to have a special super-sized advisory committee in July re-review the safety of Glaxo's diabetes drug Avandia. Better book a room now in Gaithersburg or Silver Spring, Maryland--the two places the agency holds these things. Why the FDA doesn't do them in Washington, DC is one of the many mysteries surrounding the agency.
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