Last March, Orexigen ($OREX) landed in hot water with researchers, the FDA and marketing partner Takeda when it blabbed some early trial results that falsely suggested its obesity med could improve cardiovascular outcomes for patients. Just over a year later, it's still facing the consequences.
Former FDA deputy commissioner Joshua Sharfstein is calling for U.S. regulators to propose restrictions on the drug, Contrave, to counter the "misleading information" from the California company, Forbes reports. And the FDA has some tools to do that, he noted, including a Risk Evaluation and Mitigation Strategy.
His recommendation comes along with data from the now-nixed trial in question, newly published in the Journal of the American Medical Association. The data not only fail to show a cardiovascular benefit for Contrave, but on top of that, can't establish that the product is even a safe, long-term option for obesity.
"The cardiovascular safety of this treatment remains uncertain and will require evaluation in a new adequately powered outcome trial," researchers concluded.
|Orexigen CEO Mike Narachi|
The trouble started for Orexigen when CEO Mike Narachi--who critics claim shouldn't have been privy to the outcomes data in the first place--took rosy results from the study's 25% mark to file for a patent. That move made the info public, prompting a positive reaction from some analysts and suggesting Orexigen could gain a serious leg up over foundering rivals Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA).
But early data can be misleading, and that fact spurred Cleveland Clinic researchers to cancel the trial. Partner Takeda wasn't too happy about that, and it threatened to pull the plug on the pair's marketing partnership until Orexigen vowed to pick up the tab on a new, $200 million-plus study.
The way Sharfstein sees it, though, results from that study won't be ready for quite some time, and in the meantime, doctors and consumers should know what they're getting into. Around 55,000 doctors have written more than 765,000 Contrave scripts so far, Narachi told investors in February.
Meanwhile, some analysts think Contrave is doomed to fail no matter what happens at the FDA. As RBC Capital Markets' Simos Simeonidis wrote in a recent note to clients, now that the Takeda partnership is in its second year, the Japanese pharma is no longer required to spend as much on the drug or devote as many of its sales reps to promoting it. And with Takeda on the hook for a $50 million spend in both 2016 and 2017--for a product that netted just $53 million in 2015 sales--it may not want to.
"It may be a lot cheaper for Takeda to pay whatever the penalty for breaking up and walking away from the contract may be, than staying in and trying to save this venture," he wrote.
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