Turns out the FDA isn't the only one that's been ticked off with Orexigen ($OREX) since it released some early positive cardio data for obesity drug, Contrave, last March. Marketing partner Takeda is on that list, too--and earlier this week, the Japanese drugmaker went so far as to threaten to nix the pair's pact.
Takeda wrote its partner Tuesday seeking "termination of its collaboration agreement with Orexigen based on Orexigen's material breach of the agreement," spokeswoman Sandy Rodriguez told Bloomberg in a statement. While she didn't say what Takeda considered a "material breach," she did say the two were working closely to try to resolve things and salvage their accord.
One way Orexigen might be able to do that: Pony up for a new cardiovascular outcomes study. A Cleveland Clinic-led exec committee this week told the pair to can the current trial, which was compromised when Orexigen put out rosy--and potentially misleading--results from a 25% interim analysis.
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| Cleveland Clinic's Steven Nissen |
To satisfy the FDA's postmarketing requirements, the companies are still on the hook for a study--and the new trial, which Cleveland Clinic's Steve Nissen will lead, will cost about $200 million, RBC Capital Markets analyst Simos Simeonidis told Bloomberg. Originally, the drugmakers had planned to split the costs, but as Orexigen told the news service in a statement, Takeda now wants it to shoulder the entire financial burden.
If Takeda does stick around, it'll have its work cut out for it. This week's round of data from the now-halted trial--an interim analysis from the 50% mark--erased Contrave's perceived cardiac benefit, with the drug posting only a non-statistically significant 12% decrease in major events such as heart attack and stroke.
Now, that lack of a cardiac marketing advantage will keep Contrave on a more even playing field with competitors Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA) and Eisai, in an obesity market that's become pretty crowded. Still, though, some analysts think Contrave will eventually take the cake: Wells Fargo's Matthew Andrews has said he sees Contrave generating $634 million in 2020 sales, versus $481 million for Belviq and $396 million for Qsymia.
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