Orexigen and Takeda reboot Contrave collaboration
pharmafile | August 12, 2015 | News story | Research and Development | Contrave, FDA, Takeda, orexigen, weight loss drugs
Orexigen has agreed to foot the $200 million bill for a new trial to prove its claims that Contrave, the weight loss drug it is jointly marketing with Takeda, also reduces the risk of heart disease.
In March Orexigen fell afoul of FDA regulators for prematurely releasing data suggesting that Contrave (naltrexone hydrochloride/bupropion hydrochloride) significantly reduced heart attacks, strokes and other cardiovascular events by 41% compared to placebo.
However, researchers overseeing the trial later published data from 9,000 patients who were treated with Orexigen, which suggested that Contrave’s benefits waned over time to a statistically insignificant 12% compared to placebo.
Dr Steve Nissen, a cardiologist at the Cleveland Clinic, and others from the FDA, accused Orexigen of actively preventing the full data from being published. Nissen also accused the company of misleading patients and investors.
Takeda threatened to instigate dispute resolution procedures to extricate itself from the controversy, claiming breach of the partner’s agreement, unless Orexigen paid to run a trial to end the doubts surrounding Contrave cardiovascular effects.
The two companies have now reached “an amended and restated collaboration agreement that resolves all outstanding disputes between the companies”, they say.
“Contrave has quickly established itself as the most prescribed branded weight-loss medication in a rapidly growing market. Today, we have reaffirmed our commitment to its success in the United States,” says Ramona Sequeira, president of Takeda Pharmaceuticals USA.
While Mike Narachi, chief executive of Orexigen, adds: “Takeda’s market-leading share of voice through the sales organisation, combined with the partnership’s commitment to patient support, has enabled a strong launch and early results for Contrave. We are pleased to have realigned our partnership and look forward to working closely with Takeda to deliver continued success for Contrave in the United States.”
Lilian Anekwe
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