Orexigen Provides Progress Update on Mysimba European Marketing Authorization

SAN DIEGO, Feb. 9, 2015 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced an update on the European marketing authorization application (MAA) for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) which is being reviewed for use as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to ˂ 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).

In December 2014, the Committee for Medicinal Products for Human Use (CHMP), the centralized expert advisory committee of the European Medicines Agency, adopted a positive opinion and recommended that the European Commission (EC) grant a centralized marketing authorization through a binding EC decision.  The CHMP last week released minutes from their December meeting stating that the positive opinion for Mysimba was adopted by a majority vote with 31 member states in favor and two opposed.

Procedurally, a positive opinion and recommendation of the CHMP is then referred to the EC's Standing Committee for Medicinal Products, which is composed of representatives from each member state. In a process that occurs either through a written procedure or in a meeting, the Standing Committee reviews the draft EC decision to grant marketing authorization. Draft decisions are adopted by majority vote.

The EC has recently informed Orexigen that at the request of one member state, the draft EC decision granting marketing authorization for Mysimba will be reviewed during a meeting of the Standing Committee being held in March.

"We are pleased with the progress we have made and the strong positive vote from the CHMP, and we look forward to the outcome of the European Commission procedures," said Mike Narachi, CEO of Orexigen. "We are confident Mysimba will become an important new treatment option for the many patients in the European community who struggle with obesity."

Orexigen retains Mysimba/Contrave® rights for all territories outside North America and plans to secure partnerships and marketing authorizations in order to commercialize the medicine globally.

About Mysimba
Mysimba is a centrally acting anti-obesity product composed of a fixed dose combination of the active substances naltrexone and bupropion. Naltrexone is a mu-opioid antagonist and bupropion is a norepinephrine and dopamine reuptake inhibitor. Both compounds affect key circuitry in two areas of the brain. The first is the arcuate nucleus of the hypothalamus, an area of the brain that plays a critical role in the control of food intake and energy expenditure. The second is the mesolimbic dopaminergic reward system, a region of the brain that is important for processing the rewarding aspects of food and food related stimuli. Both bupropion and naltrexone act in the mesolimbic reward system to influence eating behavior.

About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) for weight management. Orexigen owns all rights to Mysimba outside of North America, and the Company's strategy is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. In the United States, the drug has been approved by the United States Food and Drug Administration and is marketed as Contrave® by Orexigen's partner for North America, Takeda Pharmaceuticals. Further information about the Company can be found at http://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 review of the draft EC decision to grant marketing authorization for Mysimba in March; Orexigen's confidence that Mysimba will receive marketing authorization in Europe; plans to secure marketing authorizations and partnerships for commercialization of Contrave and Mysimba across the globe; and the potential for Contrave and Mysimba to achieve commercial success and Orexigen's confidence that Mysimba will become an important treatment in the global obesity market. Inclusion of forward looking statements should not be regarded as a representation by the company 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 business, including, without limitation: the ability for Mysimba to obtain marketing authorization in Europe; the ability to obtain partnerships and marketing authorizations globally; competition in the global obesity market, particularly from existing therapies; the ability to obtain and maintain intellectual property protection for Contrave and Mysimba; additional analysis of the interim results of the LIGHT study or new data from the continuing LIGHT study and the additional cardiovascular outcomes trial, including safety-related data, may produce negative or inconclusive results; the therapeutic and commercial value of Contrave and Mysimba; and other risks described in Orexigen's filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen does not undertake any 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 SEC on November 10, 2014 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 "Investors." 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, Inc.

Related Links

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