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Let’s talk a little bit about the path to approval in the U.S., and the European authorities have also indicated an interest in seeing cardiovascular data prior to our approval, so I think the data from the light study interim analysis will be necessary to go forward with Contrave. So in our NDA review by the FDA, there was only a single approval deficiency. Everything else, the boxes were checked but they wanted us to rule out excess cardiovascular risk with a large outcomes trial that was a placebo controlled randomized trial. We took about nine months with the FDA, unfortunately, to clarify what ruling out excess risk meant, and that led to the design of the light study so it was confirmed through a formal dispute resolution process with the FDA, so we got a very high level commitment to the parameters that would guide approval from the Director of the Office of New Drugs. Dr. Don Jenkins led that reply to our appeal.And then with the review division, we worked out a special protocol agreement in very short order so that we had top-to-bottom alignment at the FDA of exactly what it’s going to take to drive this assessment of cardiovascular risk for an obesity therapeutic like Contrave, and that assessment essentially mirrored the diabetes guidance. We have to rule out a certain amount of risk to get approval with an interim analysis, and then you finish the study and rule out excess risk. And the risk that they’re asking people to rule out, and now the Europeans have actually adopted very, very similar guidance for diabetes drugs, where what they’re saying is the benefits that are presumed from lowering blood sugar for diabetes drugs or lowering weight with obesity drugs should outweigh at least 16 excess cardiovascular events – heart attack, stroke, cardiovascular death – to get approved. And then it should rule out at least six excess events per thousand years of exposure, so it’s a pretty tight hurdle for safety. We want to make sure there is not any more than 16 to get approved and 6 per thousand years of exposure, and the benefits clearly outweigh that in their mind. Now, that’s a subject decision.
Then you translate that into the statistics for the studies on where you need to rule it out on a hazard ratio basis, and I’ll go through that. But our trial essentially mirrored the diabetes guidance for absolute risk, the relative risk or the hazard ratio scores, then we need to rule out a doubling of risk for approval and a 40% increase in risk for the final analysis. An event-driven trial, so that means we need about 87 events to do that with high confidence for the interim analysis, and the trial is basically a very simple, straightforward study that’s tracking heart attack, stroke and cardiovascular death. That’s the primary and secondary endpoint, and an intent to treat basis.Read the rest of this transcript for free on seekingalpha.com