Orexigen's Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) Receives Positive CHMP Opinion Recommending Approval for Weight Management in the European Union

Dec 19, 2014, 07:19 ET from Orexigen Therapeutics, Inc.

LA JOLLA, Calif., Dec. 19, 2014 /PRNewswire/ -- Orexigen Therapeutics (NASDAQ: OREX) announced today that the Committee for Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a centralized marketing authorization for Mysimba™ (naltrexone HCI / bupropion HCI prolonged release), 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).

"The prevalence of obesity has more than tripled in many European countries in recent decades, and this rise in obesity has been accompanied with an increase in comorbid conditions including diabetes, cardiovascular complications, and fatty liver disease," said Nicholas Finer, BSc (Hons), MBBS, FRCP, Honorary Professor, National Centre for Cardiovascular Prevention and Outcomes, University College London Institute of Cardiovascular Science. "New treatment options are sorely needed in Europe where there is currently only one prescription drug available for weight management, a lipase inhibitor, which was approved in 1998. I am pleased the CHMP adopted a positive opinion for Mysimba after a careful assessment of its benefits and risks."

The CHMP opinion was based on the results of four Phase 3 clinical trials evaluating Mysimba in more than 4,500 overweight and obese patients including a dedicated clinical trial in obese patients with diabetes. The CHMP also reviewed the interim analysis of the Light Study, a cardiovascular outcomes safety trial with more than 8,900 patients evaluating the effects of Mysimba on heart attack, stroke and cardiovascular death.

The CHMP is responsible for scientific assessment of medicinal products seeking centralized marketing authorization throughout the European Union (EU) and EEA (European Economic Area). The CHMP's positive opinion is now referred to the European Commission for a binding decision to be adopted to grant a centralized marketing authorization for Mysimba. A positive decision will allow Mysimba to be placed on the market in all EU member states, and Iceland, Liechtenstein and Norway.  

"We are delighted with the CHMP opinion and look forward to the completion of the European Commission's review in early 2015," said Michael Narachi, CEO of Orexigen. "With both the US approval and this positive endorsement by the CHMP, we will advance our plans for partnership and commercialization of Contrave and Mysimba across the globe."

About obesity in Europe

According to the World Health Organization (WHO), the epidemic of obesity poses one of the most serious public health challenges in the European Region. The prevalence of obesity has risen up to three-fold in the last two decades, and WHO estimates that over 20% of the adult European population is obese (BMI≥30). Overweight and obesity contribute to a large proportion of non-communicable diseases, shortening life expectancy and adversely affecting the quality of life. More than one million deaths in the region annually are due to diseases related to excess body weight. Adult obesity and overweight are responsible for up to 6% of health care expenditure in the European Region; in addition, they impose indirect costs (due to the loss of lives, productivity and related income) that are at least two times higher. Overweight and obesity most affect people in lower socioeconomic groups, and this in turn contributes to a widening of health and other inequalities.

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 behaviour.

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 Europe, the European Commission is expected to issue a binding decision on granting of a marketing authorization in early 2015.  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 issuance of the European Commission's binding decision on granting of a marketing authorization in early 2015; the potential for further marketing authorizations and partnerships for commercialization of Contrave and Mysimba across the globe; and the potential for Contrave and Mysimba to achieve commercial success in the global obesity market. Inclusion of forward‐looking statements should not be regarded as a representation by 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: Orexigen's dependence on Takeda to carry out the commercial launch of Contrave in North America; 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. 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 Securities and Exchange Commission 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.

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SOURCE Orexigen Therapeutics, Inc.



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