Contrave becomes the first casualty from the obesity class of 2012

It is a shame to see the end of Orexigen, the company that in 2014 brought its weight loss drug Contrave to the market. A drug that could have gone down in history as the first weight loss drug with a published CV outcomes study, might instead be a case study on the consequences of compromising your own clinical trial.

Relative to its competition, Contrave is pitched as the ‘Goldilocks’ of weight loss drugs: not too strong, not too weak, acceptable side effects – just right. However, none of the available weight loss drugs (Belviq, Qsymia, Contrave, and Saxenda) induce enough weight loss to be a desirable long-term treatment. DRG has written about the following extensively; all weight loss agents suffer from high-out-of-pocket costs, modest weight loss and subsequently, poor patient persistence. The sales performance of Contrave was poor and once Takeda returned U.S. marketing rights for Contrave back to Orexigen in 2016, Orexigen was doomed.

Contrave’s FDA approval was granted on the condition that a CV outcomes trial was conducted and interim data presented, objectives Orexigen had to meet to keep Contrave on the market. Therefore Orexigen, with no other marketed products, could begin to generate revenue from Contrave and seek further investment while the hugely expensive long-term outcomes trial was ongoing. A partnership with Takeda helped finance the LIGHT outcomes study, and a new and realistic approval process for weight loss drugs was established. Contrave’s route to market offered encouragement to the industry, showing that the FDA was becoming more receptive towards weight loss agents.

Unfortunately, without insurance coverage, drugs fail commercially. Contrave may be the most frequently prescribed obesity brand, but U.S. sales of $75m in 2017 weren’t enough. Orexigen leaked interim data from the LIGHT CV outcomes trial, which led to the termination of the trial and triggered the 2016 break-up of the Takeda partnership. As is stands, another CV outcomes trial of Contrave is needed for it to remain on the market, and that is unachievable for Orexigen.

What happens next? Orexigen is auctioning off its assets in May 2018. Takeda could re-acquire Contrave but it is hard to imagine it touching this sector again in a hurry. Another possible outcome is the acquisition by a minor player, as we have seen before in the metabolic disorders space. Krystexxa is an effective gout drug that didn’t generate enough sales to keep the lights on at Savient Pharmaceuticals. Crealta picked up Krystexxa when Savient filed for bankruptcy in 2013, and now the drug lives on in the hands of Horizon Pharmaceuticals in the United States. Hopefully, the obesity space can retain the availability of one of its few treatment options but the hefty burden of a CV outcomes trial requirement make Contrave an unattractive and risky asset.

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