Shares of Orexigen Therapeutics ($OREX) shot up 18% yesterday after the biotech laid out a special protocol assessment pact with the FDA, detailing the design of a big new safety study of its weight drug Contrave. But investors are going to have to wait quite awhile before they get a better idea of the developer's chances at a comeback.
Orexigen made headlines when it raced Vivus ($VVUS) and Arena ($ARNA) to the FDA with an application for a weight drug, vying for the lead in a race for the first new obesity drug approval in more than a decade. But the biotech was handed a major defeat when regulators concluded that they needed hard evidence that a treatment designed to be used by a mass audience didn't have any hidden cardio risks. Orexigen then lined up $87 million in new funding for the study, vowing to complete the quest.
In the SPA, Orexigen and the FDA agreed that investigators will recruit 10,000 patients and then see how long it takes to hit 87 major adverse cardio events in the patient population. Once they hit that stage--which the developer estimates will be in less than two years--Orexigen will come up with an interim analysis and see if it can win an approval with the data.
"A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy," says CEO Michael Narachi. "We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."