- Obesity medication Contrave makers Orexigen and Takeda have filed a patent infringement claim in Delaware district court against Actavis, which is trying to elbow its way into the weight-loss market with a Contrave copycat.
- The suit essentially freezes Actavis' efforts to gain FDA approval for its generic formulation of Contrave for 30 months, barring a positive court decision for the company.
- This latest challenge comes shortly after a well-publicized situation in which a data leak from an important Contrave trial evaluating cardiovascular risk led to the trial being halted, and to Takeda reportedly considering arbitration to make Orexigen pay for the cost of a new trial.
The backstory: Orexigen got into hot water in March after prematurely releasing data implying that Contrave significantly reduced adverse CVD events like heart attacks and strokes (to the tune of 41%)—particularly staggering for an obesity drug. Officials overseeing the trial and others from the FDA slammed the unauthorized data release and said the results were "unreliable" and "misleading."
Then Takeda threatened to end its pact with Orexigen, because there are still $200 million in outstanding costs associated with the halted trial. To make matters worse, a halfway interim analysis showed that the CVD benefit originally uncovered in the trial was pretty much nonexistent (data that was released in an extraordinary way by the Cleveland Clinic, where the trial was being run). Although there was a 12% decrease in major CVD events, including heart attack and stroke, in the trial, it was nonsignificant.
As for Actavis, the company has shown determination in its efforts to move into the weight-loss market—first when it attempted to gain approval for a generic version of Vivus's Qysmia and now with its efforts to introduce a copycat version of Contrave. As it stands now, all these issues are being litigated.