I wish I knew but I'm really looking forward to Dec. 7, when the FDA brings together its weight-loss and drug safety experts once again to review Orexigen's diet pill Contrave. I will definitely be live-blogging this panel; stay tuned for details.
Like the tortoise's race against the hare, Orexigen has some real advantages over its chief rivals. The FDA and its two previous weight-loss advisory panels threw some nasty stuff at Vivus (VVUS) and Arena Pharmaceuticals (ARNA). Orexigen's advantage is being last. The company should have learned enough from the previous panels to put together a presentation that answers the obvious safety questions that will be raised and argues strongly for Contrave's approval.
Like the Vivus and Arena panels before, safety, safety and more safety will be the theme of the day. Contrave is a combination pill consisting of two approved drugs, naltrexone and bupropion. Expect a lot of inquiry about elevated blood pressure, heart rate and an increased risk for seizures -- known side effects of bupropion.And like Vivus and unlike Arena, Orexigen's Contrave may not get as many questions about efficacy since patients in the clinical trials were able to lose substantial amounts of weight. It's hard to be overly optimistic about Orexigen's chances on Dec. 7. The two previous FDA panels both voted against Vivus' Qnexa and Arena's lorcaserin. Later, the FDA rejected both drugs. The approval bar for a new weight-loss drug is high! Orexigen, however, may prove once again that slow and steady wins the race.
My fellow Tweeps had a lot to say about my story Thursday detailing a wrongful termination lawsuit that accuses MannKind (MNKD) of covering up alleged data fraud in clinical trials of Afrezza, the company's inhaled insulin device. @rscalese tweets, "It is difficult to accept that Alfred Mann would risk so much after all the previous successes." Mann is the founder of MannKind, an entrepreneurial business legend and a billionaire. Many of MannKind's supporters believe in Afrezza's eventual approval because of Mann's stellar track record. I understand that, but I also know that everyone fails at some point. Isn't it smarter to look at each business venture -- MannKind, in this case -- on its own merits and forget about what Mann did or didn't do in the past? You only need to look at the recent past to find examples of highly regarded and successful business executives who fall from their lofty perch.
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