Orexigen Therapeutics Submits Contrave Marketing Authorization Application to European Medicines Agency - Company is seeking approval for Contrave for the management of obesity -

SAN DIEGO, Oct. 3, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced that the company has submitted the Marketing Authorization Application (MAA) for Contrave® to the European Medicines Agency (EMA) utilizing the EMA's Centralized Procedure. Orexigen is seeking approval for Contrave (32 mg naltrexone sustained release (SR) / 360 mg bupropion SR) for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with lifestyle modification.

Assuming successful completion of the review process and potential approval in the second half of 2014, Orexigen would expect Contrave to be available to physicians and their patients in Europe in early 2015.

"Obesity is one of Europe's great health care challenges, with the prevalence of obesity tripling in many European countries in the past few decades," said Michael Narachi, CEO of Orexigen. "We believe, if approved, a medicine with Contrave's safety and efficacy profile, including safety information derived from the ongoing cardiovascular outcomes trial, can be an important part of the solution for the management of obesity in Europe."

Orexigen is currently evaluating Contrave in the Light Study, a cardiovascular outcomes trial with more than 8,900 patients randomized to Contrave or placebo. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave.

Earlier this year, Orexigen met with the European rapporteurs to discuss the filing strategy of the Contrave MAA, and both were supportive of the company's plan to submit the MAA in advance of the Light Study interim analysis and to have cardiovascular outcomes data from the Light Study available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions. The Company and the EMA have also agreed upon a pediatric investigation plan in children and adolescents.

By early December, Orexigen expects to conduct a planned interim analysis after at least 87 major adverse cardiovascular events have occurred in the Light Study. The company also plans to resubmit the Contrave New Drug Application to the United States Food and Drug Administration by year-end.

Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories. Orexigen has licensed North American commercial rights to Takeda Pharmaceuticals.

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 3 clinical trials and for which a NDA has been submitted and reviewed by the FDA. The company has also reached agreement with the FDA on a SPA for the Light Study, the Contrave cardiovascular outcomes trial. The company's other product candidate, Empatic, has completed Phase 2 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," "will," "should," "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 MAA approval by the EMEA; the potential to submit the MAA in advance of the Light Study interim analysis; the potential to have cardiovascular outcomes data from the Light Study available for the CHMP Day 120 List of Questions; the potential for, and timing of, the interim analysis and submission of a Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE; the expected retention rate for patients in the Light Study; the probability of success of the Light Study; the possibility of resubmitting the Contrave NDA with the independent 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 safety and effectiveness of Contrave; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the SPA and the protocol for the Contrave® cardiovascular outcomes trial, or Light Study; and the potential to license commercial rights to Contrave outside North America. 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 materially from those expressed or implied 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 and retaining 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 patients treated with Contrave does not adversely affect Contrave'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 data; the potential for the Light Study to cost more than what is projected; the potential for early termination of Orexigen's North American collaboration agreement with Takeda Pharmaceutical Company Limited; the costs and time required to complete additional clinical, non‐clinical or other requirements prior to any resubmission of the Contrave NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital to fund our operations through potential approval of Contrave in 2014; Orexigen's ability to enter into a collaborative partnership for Contrave outside North America on acceptable terms, if at all; and other risks described in Orexigen'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 Annual Report on Form 10‐K filed with the Securities and Exchange Commission March 14, 2013 and its other reports, which are 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.

Orexigen Contact:

Media Contact: 

McDavid Stilwell

Denise Powell

VP, Corporate Communications and Business Development

BrewLife

(858) 875-8629

(510) 703-9491

SOURCE Orexigen Therapeutics, Inc.



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