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Orexigen Therapeutics, Inc. (OREX)
Lazard Capital Markets 9th Annual Healthcare Conference Call
November 13, 2012 1:30 PM ET
Unidentified Company Representative
Previous Statements by OREX
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In general, we like to think of Orexigen and our first drug Contrave as poised to deliver, our regulatory path is very, very clear. We have the Light Study that's running incredibly well from an execution standpoint, which will yield interim data sometime next year that we can use for approval from the FDA.
We also think the probability of success with these non-inferiority trials is extremely high, and I'll go through some of that in the area that I'll focus on today. And then the past commercial success has some of the chief elements that you would look for in kind of a dream market large and growing, unmet need, limited competition, the differentiated product profile that conserves the needs of important segments of the population.
And then really importantly for small companies, we have a large skilled partner that owns almost all the commercialization expenses, so we don't have to bear the burden of building a market or commercializing and trending away to success in this market. I will talk about that as well in the focus area.
The Light Study, it's a large outcome study that we're after run to rule out of doubling a risk, prior to getting on the market. The paradigm that we have for approval is very similar to the diabetes drug paradigm, where you have to collect enough cardiovascular safety data to rule out risk at a certain level through approval based on an interim analysis or meta analysis, in our case an interim, and then you continue to squeeze out risk as we go forward in the marketplace.
Our complete response letter from the FDA identified this is the single approval deficiency. Everything else in the application was fine and we're heavily focused on giving the data for the study for the interim analysis, so that we can bring Contrave to patients.
The protocol for the study was based on a formal dispute resolution process with the FDA where we escalated that process up to a several levels above the review division with the Office of New Drugs, that with Dr. Jenkins sharing that meeting, who is the Director of the Office of New Drugs. We got agreement on a paradigm that's substantially the same as the diabetes drug paradigm in terms of excess risk to exclude. We must exclude the 95% confidence interval, up 2.0 or doubling of risk, with an interim analysis of this study, which will take about 90 major adverse cardiovascular events. And then we submit that with resubmission, as part of the resubmission to go forward for approval.
The study continues and once we gather about 370 events, there is the final analysis of the study, and there the hurdle is to rule out a 40% increase in risk. We've talked a lot about this paradigm for about a year, since we achieved this agreement with the FDA. We then bolstered that agreement with the special protocol assessment which was agreed toward the review division. So we've got top to bottom alignment of what is going to take for Contrave approval hurdles.
We began enrolling the clinical trial in June. A blue line is our projected enrollment which was already fast. We thought in the U.S. 300 centers we can enroll the study 7,000 or 8,000 patients in about 18 months. We've actually been able to enroll the study beyond those numbers already. We think by the end of the year, just six or seven months from starting the trial, we'll probably enroll in randomized 9,000 subjects.
The cost are front end loaded, so what we're doing is we're taking some of the cost from 2013 and putting them into the 2012, but the overall cost actually is reduced by enrolling it heavier upfront. And if you think about it this is an event driven trial. So we really need a lot of observation time of on-label patients.
We picked the higher risk subset of on-label patients. And if we observe them for about 70,000 months of our total observation time, we should get 70,000 months total. So that's 7,000 patients times 10 months or 10,000 patients into seven months, to accrue enough events, so that we can get 90 events to look at the difference between the two groups and make a resubmission.
So well on our way, the trial has some unique features that I think are not only important to understand for Orexigen, but maybe generally applicable in the overall drug development space. The most important being, that we wanted the trial to be generalizable, we did not want to do a canary in the coalmine experiment, we take the highest risk people that would never be truly eligible for the drug anyway, and stress the system to see if there is risk.
So we wanted to do is, let's work with the largest emphasize, lower rent rates, on-label population and tested in a real world way. So here the most real word element of the study is that if you don't respond to the drug, you don't continue which is a way most drugs get used.