The message from Orexigen Therapeutics (NASDAQ: OREX ) during its fourth-quarter conference call yesterday was clear: Everything is proceeding as planned.
The corollary to that message is that it's going to be awhile before the biotech is able to launch its obesity drug, Contrave.
The Food and Drug Administration made the company run a clinical trial to confirm that there weren't any heart-related complications with Contrave. The trial is now fully enrolled and is on track for an interim look in the second half of the year. At least, as best the biotech can tell.
The interim look will happen after the occurrence of a certain number of cardiovascular events, such as heart attacks or strokes. As the trial progresses, the committee should have a better idea of whether the trial will fall in the estimated 1% to 2% event rate. If it's low -- closer to 1% -- the interim peek will be later, potentially pushing resubmission into early 2014. Orexigen won't know the event rate, but the data monitoring committee will let the company know if it's on track to finish later this year.
Orexigen and marketing partner Takeda could be a year or more behind the launch of obesity drugs from VIVUS (NASDAQ: VVUS ) and Arena Pharmaceuticals (NASDAQ: ARNA ) . But I'm not sure that's the worst thing in the world.
VIVUS is off to a slow start. Despite the large number of obese Americans, doctors aren't prescribing Qsymia in mass. Patients aren't clamoring for the drug in part because of high out-of-pocket expenses. It's going to take education of doctors and insurers to get sales up. That education will be more about the obesity space in general than specific drugs, so Orexigen will benefit from VIVUS' and Arena's efforts.
Takeda is the best marketing partner. VIVUS doesn't even have one. Arena has Eisai, but I think Takeda is likely to be more effective since it sells diabetes drugs Actos and Nesina. The former is off patent, but Nesina was just approved, giving Takeda sales reps two drugs to hock to the doctor once Contrave gets approved.
Of course, first the cardiovascular study has to come back clean. Tick tock. Tick tock.
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