Orexigen® Therapeutics, Inc. (Nasdaq:OREX - News) announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss. Orexigen sought the meeting to gain clarity on the approval deficiency stated in the Complete Response letter the Company received on January 31, 2011. The Complete Response letter requested that the Company conduct a randomized, double-blind, placebo-controlled trial of sufficient size and duration to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the drug's benefit-risk profile.
Orexigen submitted a specific proposal to address the theoretical cardiovascular risk cited in the approval deficiency and also explored approval for a narrowed indication in patients with lower cardiovascular risk until data from the proposed outcomes trial could be reviewed for label expansion. The Division of Metabolic and Endocrinologic Products (DMEP) advised Orexigen that the proposed cardiovascular outcomes trial would not adequately address the approval deficiency and instead, requested a pre-approval cardiovascular outcomes trial that Orexigen believes is unprecedented and would generate significantly more information than is necessary or feasible. Additionally, DMEP stated that it would not consider approving Contrave for a narrowed population without first reviewing data from a cardiovascular outcomes trial. Finally, DMEP said that it intends to hold a general advisory committee early next year to discuss cardiovascular assessment for obesity therapeutics, and that any agreement reached on the design of a cardiovascular outcomes trial would be subject to change following DMEP's interpretation of the input received at the 2012 advisory committee.
Based on DMEP's feedback, Orexigen plans to:
* appeal DMEP's responses through the formal dispute resolution process;
* put on hold any further clinical development for its obesity programs in the United States until a clear and feasible path to regulatory approval is identified; and
* accelerate the exploration of opportunities for our product candidates outside of the United States.
"The Orexigen team has been working for the last several months with leading experts in the field of cardiovascular outcome trials to develop and submit a proposal to DMEP that we believe would more than adequately address the question of theoretical CV risk," said Michael Narachi, CEO of Orexigen. "We remain very disappointed in the stance of DMEP and the outcome of the recent meeting. We have serious concerns about the broader implications these actions may have on innovation in the obesity space and the availability of much needed treatment options for obese patients in the U.S."
Since receiving the Complete Response, Orexigen has been evaluating other opportunities where it can leverage its management team, cash and other resources. With the result of this recent meeting, Orexigen plans to advance its evaluation of new opportunities.
Orexigen management will host a call and webcast to discuss this update today at 8:00 a.m. Eastern time. The live call may be accessed by phone by calling (866) 730-5771 (domestic) or (857) 350-1595 (international), participant code 27244834. The webcast can be accessed live on the investor relations section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
Contrave, an investigational combination therapy of naltrexone HCl and bupropion HCl, was studied for its ability to help people with obesity initiate and sustain weight loss of at least 5 percent of their starting body weight in one year. Contrave was submitted for U.S. regulatory approval in March 2010. The original submission was based on multiple clinical trials that evaluated Contrave in more than 4500 patients. Orexigen received a Complete Response letter from FDA on January 31, 2011.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Further information about the Company can be found at www.orexigen.com.
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, the pursuit of additional assets, the potential for, and timing of, a submission to the FDA of a formal appeal, and the possible outcome of such an appeal, and the potential for, and timing of, approval for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: Orexigen's ability to appeal DMEP's decisions; the likelihood of success of the appeal; Orexigen's ability to agree with the FDA on the design and feasibility of a cardiovascular outcomes trial, Orexigen's ability to conduct such a cardiovascular outcomes trial, Orexigen's ability to demonstrate that the risk of major adverse cardiovascular events in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to acquire new assets; Orexigen's ability to attract and retain key personnel and the effect of the loss of key personnel; Orexigen's ability to maintain sufficient capital and implement expense reduction measures; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q, which we intend to file with the Securities Exchange Commission this week and will be available from the SEC's website (www.sec.gov) and on our website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.