Orexigen Therapeutics (OREX) Presentation at Morgan Stanley Healthcare Conference September 12, 2012 10:55 a.m. ET Executives Michael Narachi - President and CEO Analysts Marshall Urist - Morgan Stanley Presentation Marshall Urist - Morgan Stanley
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So there are many approaches that are being developed right now, many in earlier stages, lots of devices, surgical approaches, and a handful of therapeutics in the late stage, and a few in the earlier stages.And I think so far chronic disease in general has been a difficult area to really get a handle on and to create a care system than can tackle chronic disease. We’ve done a reasonable job with this dyslipidemia, hypertension, diabetes, where the therapeutic approaches have become integrated into primary care, at least in the United States. But even in those settings, there could be a lot more effective therapy compliance, persistence, and integration of care. So when we started with the obesity therapeutic, we thought how do we not only develop an effective therapeutic that can help a lot of people, but let’s think longer term when we commercialize this product with our partner, North America Takeda, and we are seeking a partnership for the rest of the world. How do we integrate the therapeutic into a robust, chronic care maintenance program? And so that’s something to keep in mind, and I’ll talk a little bit about a program that we’re piloting that we call Weight Mate, where we’ve got the weight loss pill, Contrave, plus a program that, together, in a hand in glove manner, can deliver a much more effective and long term change program. The therapeutics that I’ve seen so far, including Contrave, I think enable a higher level of success if a patient is committed to change, enter into some diet and exercise program, whether it’s personal or a commercial program, the therapies enable much higher levels of success. And so that’s the approach that we’re taking. Now, we submitted our Phase III data and our program data to the FDA for approval in early 2010. We had a positive advisory panel, the first positive panel in 13 years, but the FDA had concerns around drugs for cardiovascular safety after the results of the sibutramine large outcomes trial, which turned out negative, about a 16% increase in risk.
With the full NDA review they identified one approval deficiency, which is a large one for us, which was to rule out excess cardiovascular risk. We then took about 9 months to clearly identify with the FDA what the hurdle was, to rule out risk, and as it turns out it’s very similar to the diabetes guidance, where you can get on the market with an interim look, of a large outcomes database, and rule out a certain level of risk.For us, that risk capping is we have to rule out a doubling of risk at the interim, and then that would warrant approval, and then you move on to the final analysis, which would rule out about a 40% increase in risk. The absolute risk that we’re ruling out is identical to what’s ruled out in a diabetes patient population, in terms of number of excess cardiovascular events. So we went, then, and raised the capital and we’re lucky to have the institutions that put the money in to fund that large outcomes trial. That trial is about a 7,000 to 10,000 patient study, where we need about 90 events at the interim and about 370 events at the final. It’s an event-driven trial. And then we set out to rapidly enroll that trial, so that we could get the answer sooner, and pull forward the ultimate introduction of the product and the generation of the data. We have announced two times now since we started the trial in June that it’s going faster than expected. In our last announcement, which I believe was last week, we said we’ll actually fully enroll the trial in this calendar year. So it’s an unprecedentedly fast enrolling trial. And I think one of the reasons it’s enrolling so fast, first it’s a bit of a proxy for the pent up demand in the market. Because the value proposition for the study is weight loss, value proposition. Read the rest of this transcript for free on seekingalpha.com