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Orexigen Therapeutics (OREX)
Credit Suisse Group AG Healthcare Conference
November 15, 2012 03:30 PM ET
Michael Narachi - President & CEO
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Thanks Lee. Thanks for your interest. Looks like we have a relatively small group here so assume that there are some familiarity with the story and move through quickly and then if people have questions that could be interesting during the breakout. I’ll be making the usual forward-looking statements. Things do change in our industry as you know quite a bit from time to time all of the filings about risk factors et cetera can be found on our website and in our SEC documents.
I feel that we’re poised right now to deliver with Contrave in the obesity space just a general broad view. We have gained incredible regulatory clarity on what it will take for Contrave to be approved by virtue of the Light Study which is currently been conducted. I’ll talk a bit about that in that presentation and we feel the probability of success of the Light Study is high and I will go through the specifics of why we think that’s true. It's a large safety outcomes trial. The market place we don’t need much background on how large it is and that it's growing. Unfortunately the unmet need is high; there is very limited competition or promotion in this space today. We believe Contrave has a favorable and differentiated product profile and probably most importantly in-light of recent events in this space. We do have already a large scale commercial partner for commercialization in North America and we would be seeking a similarly skilled partner for the rest of the world as a commercialization partner for Contrave.
We filed a complete application for approval with the FDA quite some time ago now, our PDUFA date was February of 2011, we received a CRL that identified a single approval deficiency. It was solely focused on theoretical cardiovascular risk and the need to rule out excess risk in a preapproval double-blind randomized outcomes trial. There were no approval deficiency cited, the rest of the CRL was more administrative some drug-drug interaction requirements, some small post-marketing requirement studies et cetera. So the really the only issue that we had to sort out was the exclusion of excess cardiovascular risk. It was ill-defined and ambiguous which led to trying time for the company where over a nine month period of time through a formal dispute resolution process where we escalated our appeal through the hierarchies at the FDA to get clarity on exactly what it would take to rule out that risk and as it turns out it's a very similar almost identical paradigm to all diabetes drugs where certain amount of risk needs to be excluded prior to approval then you can put an interim look at data and you complete the study and check for further decrease rolling out excess risk at the final analysis post approval.
Protocol that we got is based on guidance written guidance from the Director of the Office of New Drugs at FDA and then we gained top and bottom alignment by also agreeing to the specifics of the protocol and special protocol assessment with the review division. Basically what we need to do is rule out excess risk a doubling of risk to get on the market and rule out a 40% increase in risk in a post-approval setting at the conclusion of the trial.
The last point in the slide it points out something that recently occurred, we went back to the FDA and asked is there a further efficiency we can gain with the data and we ended up agreeing at the center level with Dr. Throckmorton that we could resubmit the NDA prior to getting the data from the Light Study and then supplement if you will or add the data during the typical six month resubmission Type 2 PDUFA clock. So we will submit an NDA sometime next year when we have confidence that we will have the data sometime during the review and then we will add that data.
The details of that are still getting worked out with the review division. We should expect further clarity on that same. The Light Study itself is study conduct that pace in enrollment is going excellent, far faster than we expected. We did many innovative things to rapidly enroll this trial and you can see from the expectations on the blue line versus the results that we delivered for the trial executions gone incredibly well. We now expect to have completed enrollment this year with some where close to 9000 patients randomized. Then those patients stay in the trial and as we observe them, we are observing them really up for only one thing cardiovascular events, heart attack, stroke and CV death. Those are the combined end points for the study.
But once they are in the trial events have already been accumulating but and then just go forward and we observe them in a double line randomized way. They entered the trial and enroll into a run-in period if you will for two weeks and in that two weeks the main thing that happens is we shake out people who really don’t want to be in a long term clinical trial.