Orexigen Therapeutics, Inc. (OREX)
Company and Light Study Update Conference Call
October 22, 2012, 08:30 a.m. ET
Heather Turner - SVP, General Counsel and Secretary
Mike Narachi - President and CEO
Jay Hagan - CBO
Preston Klassen - SVP, Head, Global Development
McDavid Stilwell - VP, Corporate Communications and Business Development
Cory Kasimov - JPMorgan
Steve Byrne - Bank of America/Merrill Lynch
Marko Kozul - Leerink Swann
Simos Simeonidis - Cowen & Company
Jason Butler - JMP Securities
Lee Kalowski - Credit Suisse
Corey Davis - Jefferies
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I will now turn the presentation over to your host for today’s call, Heather Turner, Senior Vice President and General Counsel of Orexigen. Please proceed.
Hello and thank you for joining us this morning. I’m joined on this call by Mike Narachi, Chief Executive Officer; Jay Hagan, Chief Business Officer; Dr. Preston Klassen, Senior Vice President and Global Head of Development; McDavid Stilwell, Vice President of Corporate Communications and Business Development.
Please note that all of the information discussed on the call this morning is covered under the Safe Harbor provisions and Private Securities Litigation Reform Act. I caution listeners that during this call company’s management will be making forward-looking statements. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company’s business. These forward-looking statements are qualified in their entirety by the cautionary statements contained in today’s press release and the company’s SEC filings including the Form 10-Q company filed on August 9, 2012.
The content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast October 22, 2012. Orexigen undertakes 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 hand the call over to Mike Narachi, Orexigen’s Chief Executive Officer to provide an overview of today’s call. Mike?
Thanks Heather. This morning we issued a press release announcing that we have received a response to a formal dispute resolution request from the FDA Center for Drug Evaluation and Research. We also announced an update to enrollment in the Light Study. Each of these developments on its own has the potential to reduce the time to a resubmission of the Contrave NDA.
Given the recent regulatory progress with obesity therapeutics in the U.S. such as the general obesity at (inaudible) and two recent approvals of obesity therapeutics, Orexigen requested that Contrave be considered for approval on the basis on existing data together with a post marketing requirements to supply the interim cardiovascular outcomes status soon after approval. We either deny this request reaffirming that cardiovascular outcomes data from the interim analysis of the Light study is required part of the approval. However, CDER indicated that it was highly supportive of the exploration of the factor path to resubmission of the Contrave NDA. The procedural details have yet to be worked out. And we plan to engage with the agency as soon as possible to more fully define how this might be implemented.
I think it will be helpful if I read to you the relevant section of the brief letter from CDER that makes us optimistic that there may be a faster path to resubmission. This is from a section under the heading, “Recommendations for next steps. In the absence of an acceptable pathway to approval utilizing labeling, you have suggested another pathway for the review of Contrave in lieu of waiting for the interim results from the cardiovascular outcomes study to resubmit your application. You and OND have already begun important work to most efficiently use the data collected as part of the ongoing CVOT. The additional step You suggest it's a plan for a submission to be under review at the time of the interim analysis in order to be as prepared as possible to act soon afterwards represents a further refinement of that work. While there are procedural issues to be addressed, I’m highly supportive of discussions with CDER about this approach in this critical area of public health need”.
During the course of our engagement with FDA we have been impressed with the seriousness with which FDA is confronting the obesity epidemic as a public health problem and are pleased with ongoing dialogue we continue to have with FDA.
This morning’s press release also contained an update on the Light Study. As you know when we kicked off in Roman in June, we put in place numerous tactics designed to accelerate enrollment. Today we announced that we have enrolled more than 7,000 patients into the study after just 4.5 months. And we plan to enroll approximately 9,000 patients by the end of this year. With the resulting increase in observation time in the study the time to accrual of the 87 major adverse cardiovascular event that are needed to conduct the interim analysis should occur about two months sooner potentially as soon as the second quarter of 2013.
Of course, the actual timing of the 87th event will be dependent on the observed event rate in the study and at this time it's still too early to accurately estimate the event rate. We are happy that the FDA recognized the benefit of being prepared to act on contrary soon after the interim data are available so that we and our partner Takeda to bring what we believe is an important new medicine to patients as quickly as possible. And while we have much work ahead of us, I’m pleased with this amazing progress.