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Orexigen Therapeutics CEO Discusses Q2 2012 Results - Earnings Call Transcript

Stocks in this article: OREX

The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, August 7th, 2012. Orexigen takes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

I will now had the call over to Mike Narachi, Orexigen's Chief Executive Officer to provide an overview of today's call. Mike.

Mike Narachi

Thanks, Heather. For the call today, I'll first provide a brief update on the progress we're making in the Contrave cardiovascular outcome study or what we call the Light Study. I'll also want to discuss the recent FDA approvals of two new obesity therapeutics and the implications of these approvals on an hour two late stage obesity product candidates, Contrave and Empatic. I'll then ask Preston to provide an update on the Empatic program. And finally, Jay will wrap up with the financial results for the second quarter, 2012. After that, we'll be pleased to take questions.

I'm very pleased with the progress our team has made in enrolling patients into the Light Study. As many of you know when we originally began planning this clinical trial, we were cautioned that industry experience would indicate that enrolling a large cardiovascular outcomes trial of 7,000 to 10,000 patients could take up to three years and may require international recruitment. When we closely examined historic reasons for such a protracted timeline, we felt we could do much better and focused our efforts on strategy to enroll the trial as expeditiously as possible.

We saw enrollment as something that was in our control and could speed the time to the interim analysis and potential approval of Contrave. Once we established our plans, we believed a reasonable estimate for enrolling this study would be 18 to 20 months. I'm pleased with the progress we've made. Early last month, we announced that more than 1,500 patients have already enrolled into the Light Study only five and a half weeks from the start of the trial with only 100 sites activated. Because of this incredible early progress, we updated our guidance for enrollment if 7,000 patients to be complete in the first quarter of 2013, as much as one year earlier than the original projections.

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