Third Obesity Drug Moves Closer to FDA Approval
Aug 29th 2013 3:23PM
Updated Aug 29th 2013 3:26PM
Arena Pharmaceuticals' Belviq, VIVUS' Qsymia, and Orexigen's Contrave were rejected by the Food and Drug Administration within a few months of each other in late 2010/early 2011. But that's where the stories of these obesity drugs diverged.
Arena and VIVUS were able to get their drugs approved without running another long costly trial. Belviq was the first drug approved, but Qsymia actually launched first while the DEA held up Belviq to decide how likely it was to be abused. Both obesity drugs are now on the market.
Meanwhile, Orexigen is still waiting to get back in front of the FDA. Fortunately, it appears the biotech won't have to wait much longer.
The agency required Orexigen to run a large clinical trial to rule out the possibility that Contrave causes heart problems. The company enrolled more than 10,400 patients and then had to wait for enough patients -- 87 to be exact -- taking Contrave or placebo to experience a major adverse cardiovascular event before the data can be analyzed.
It's rather morbid to be rooting for patients to have a heart attack or stroke, but that's what Orexigen's investors have had to do over the last year or so.
This week, the independent data monitoring committee, which gets to see the unblinded data, told Orexigen that the 87th major adverse cardiovascular event is expected to occur within the next two months to allow the company to conduct an interim analysis.
Since this is a safety study, Orexigen just needs the Contrave group to have the similar frequency of major adverse cardiovascular events as the placebo group. If it could beat the placebo group, it would be one heck of a marketing tool.
While it seems possible that Contrave could lower the likelihood of cardiovascular events since patients should be healthier after losing more weight than the placebo group, it's probably asking a lot to see a statistically significant difference during the upcoming interim analysis. The study is expected to be completed in 2017, which is a more realistic time frame to see a difference in the two groups.
Late, but not out
Usually, launching third puts a company at a disadvantage. Doctors get used to prescribing the early movers, so the latecomers have to have a distinct advantage to take market share.
Fortunately for Orexigen, few doctors have prescribed either Qsymia or Belviq, so Orexigen won't be fighting to get them to switch.
Qsymia's and Belviq's launches have been relatively weak not because doctors don't want to prescribe the drugs specifically, but because they don't want to prescribe any obesity drugs. Memories of fen-phen and Abbott Labs' Meridia are still fresh in their minds, and it's going to take time and marketing muscle to convince them to prescribe them to patients in mass.
I think Orexigen will be fine if Contrave can produce positive data and the company resubmits to the FDA by the end of the year. VIVUS and Arena's marketing partner, Eisai, will have done all the heavy lifting, and Orexigen and its marketing partner, Takeda Pharmaceuticals, can swoop in with safety data that the other two don't have, potentially registering the best launch of the three.
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The article Third Obesity Drug Moves Closer to FDA Approval originally appeared on Fool.com.Fool contributor Brian Orelli has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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