Orexigen Therapeutics has filed its obesity treatment Contrave with the European Medicines Agency with an eye to launching in early 2015.
The company is using the agency’s centralised procedure to seek approval for Contrave (naltrexone/bupropion) after meeting with the European rapporteurs to discuss the filing strategy and “both were supportive” of the company’s plan to file in advance of an eagerly-anticipated interim analysis of a cardiovascular outcomes trial called the Light study. The company and the EMA have also agreed upon an investigation plan in children and adolescents.
By early December, Orexigen expects to conduct a planned interim analysis after at least 87 major adverse CV events have occurred in Light (over 8,900 patients are in the study randomised to Contrave or placebo.) and it also plans to resubmit the combo to the US Food and Drug Administration by year-end.
News of the filing came as Simos Simeonidis, an analyst at Cowen & Co initiated coverage on the stock. He noted that “our biostatistician consultant analysed the patient population and assigned a high probability that the trial will meet the statistical hurdles for success at the interim set by the FDA”.
If all goes well, Contrave will be the third obesity drug to get to market, as both Vivus’ Qsymia (phentermine/topiramate) and Arena/Eisai’s Belviq (lorcaserin) are already available across the Atlantic, though their launches have been less than spectacular. Mr Simeonidis says that Contrave, through its two components, “could address two important issues tied to obesity: depression and cravings, both of which can lead to overeating and binging” and will also benefit from a “considerable commercial effort” by US partner Takeda, “which has significant experience marketing in the metabolic space”.
Nevertheless, he also issued a positive note on Vivus, noting that a Cowen survey of 50 obesity specialists and 50 primary care physicians “identified Qsymia as the drug with the strongest efficacy, and projected it to be the market leader in the obesity space”. In another report, Mr Simeonidis said Belviq “has a role in the new obesity landscape, but its efficacy is modest and its safety profile is not without its issues”.
He concluded by saying that if Light interim data are positive, Orexigen, “with its lean corporate structure and relatively low spend, could become a takeover candidate, with Takeda as the most likely acquirer”.
