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Orexigen Therapeutics, Inc. (OREX) Announces Progress With FDA on a Faster Path to Resubmission of the Contrave NDA  
1/7/2013 10:44:59 AM

SAN DIEGO, Jan. 7, 2013/PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced progress with the United States Food and Drug Administration (FDA) on a faster path to resubmission of the Contrave® (naltrexone SR / bupropion SR) New Drug Application (NDA).

Consistent with the spirit of the formal dispute resolution request (FDRR) response letter issued to the Company in October by the FDA's Center for Drug Evaluation and Research, the Division of Metabolism and Endocrinology Products (DMEP) has proposed a resubmission procedure that allows the independent Data Monitoring Committee's summary report of the Light Study interim analysis to form the basis of the resubmission of the Contrave NDA. The complete clinical study report (CSR) for the interim analysis, which would ordinarily form the basis for the NDA resubmission filing, would be supplied to the FDA during the review within 60 days of the NDA resubmission.

The Data Monitoring Committee will conduct the interim analysis after at least 87 major adverse cardiovascular events (MACE) are adjudicated in the Light Study. The timing of the interim analysis is dependent upon the rate of MACE in the Light Study. Although the annual MACE rate is still too early to predict, if it is close to the target of 1.5%, Orexigen anticipates conducting the interim analysis and resubmitting the Contrave NDA in the second half of 2013 with potential approval in early 2014.

"We are pleased that our continuing discussions with the FDA have resulted in a proposal by DMEP which expedites resubmission while also allowing the Agency the time it needs to review the Contrave NDA resubmission," said Michael Narachi, CEO of Orexigen.

Orexigen also announced continued preparation for commercialization of Contrave, if approved, with plans to initiate the Ignite Study, a randomized open-label clinical trial designed to provide additional information regarding the real world weight loss potential of Contrave therapy with a commercially available comprehensive lifestyle intervention program versus usual care. Orexigen plans to initiate randomization of approximately 200 patients into the Ignite Study later this quarter.

"2013 promises to be a pivotal year for Orexigen," Narachi continued. "We expect to receive cardiovascular data from the Light Study, to file for approval in the U.S. and Europe, and to provide additional information about Contrave's real world potential with the Ignite Study."

About Orexigen Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave®, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The Company's other product candidate, Empatic, has completed Phase II clinical trials. Further information about the Company can be found at www.orexigen.com.

Forward-Looking Statements

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," "should," "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 possibility of resubmitting the Contrave NDA with the DMC report on the interim analysis and without the clinical study report for the interim analysis; the potential to accelerate the timing of the review of the Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE and the potential resubmission of the Contrave NDA; the safety and effectiveness of Contrave; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the potential to demonstrate the real world weight loss potential of Contrave with a commercially available comprehensive lifestyle intervention program; 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: the possibility that the FDA determines not to initiate review of the Contrave NDA until it has received the complete study report for the interim analysis; the SPA is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with enrolling the appropriate patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE event data; the potential for the Light Study to cost more than what is projected; 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 maintain sufficient capital; 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 filed with the Securities and Exchange Commission November 9, 2012 and which is available from the SEC's website (www.sec.gov) and on Orexigen's 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.

Source:
Orexigen Therapeutics
McDavid Stilwell
Vice President, Corporate Communications & Business Development
858-875-8600

SOURCE Orexigen Therapeutics, Inc.


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