Orexigen ($OREX) and Takeda have already had their fair share of headaches over obesity med Contrave this year after a data leak forced the pair to abandon a postmarketing heart study. Now, though, they've got a generic to fend off, and they've sued maker Actavis ($ACT) in order to do just that.
The duo has filed a suit in a Delaware district court accusing the Dublin drugmaker of patent infringement, Orexigen said Friday. The move automatically stays FDA approval of Actavis' knockoff for 30 months, assuming a district court doesn't first declare Contrave's patents invalid, unenforceable or not infringed.
It's not the first try at a weight-loss generic for Actavis, which Vivus ($VVUS) last June hit with a similar suit after it submitted an Abbreviated New Drug Application to the FDA for a knockoff of Contrave competitor Qsymia.
The copycat challenge is the latest in a series of woes for Orexigen, which in March released some rosy early cardiac data for Contrave in a move that ticked off the FDA, researchers and marketing partner Takeda. The blabbing spurred a Cleveland Clinic-led exec committee to tell the companies to put the kibosh on the trial, and that, in turn, made the Japanese pharma threaten to end its pact with Orexigen.
One reason: The two are still on the hook for a new trial, which will cost about $200 million, according to RBC Capital Markets analyst Simos Simeonidis. Originally, the drugmakers had planned to split the costs, but now, Takeda thinks its partner should shoulder the entire financial burden.
And on top of all that? After terminating the trial, investigators released more data from its 50% mark, and at that point, Contrave's perceived cardiac benefit--and any marketing advantage that could have come along with it--had disappeared, with the drug posting only a non-statistically significant 12% decrease in major events such as heart attack and stroke.
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