SAN DIEGO, Aug. 1, 2016 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ:OREX) today announced that wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Laboratorios Farmacéuticos Rovi, S.A. (ROVI) have executed a commercialization and distributorship agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Spain. Mysimba is approved by the European Medicines Agency 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). Founded in 1946 and headquartered in Madrid, Spain, ROVI has a diversified pharmaceutical portfolio.
"We are excited to work with ROVI to bring Mysimba to the Spanish market as a differentiated new treatment option to address the significant and growing problem of obesity there," said Michael Narachi, CEO of Orexigen. "With this agreement, Orexigen's first in Western Europe, we are continuing to execute on the company's ex-U.S. commercial strategy to expand the availability of Contrave® and Mysimba for patients and physicians by establishing agreements that support the drug's commercialization in additional territories worldwide."
Juan López-Belmonte Encina, Chief Executive Officer of ROVI, commented: "We are very excited to offer specialist physicians this new pharmacological alternative for treating obesity. Obesity is a modern disease which is becoming increasingly prevalent among the adult population. This new partnership advances our long-term objective to improve patients' quality of life. In addition, we expect Mysimba to contribute to the Group's revenue in the next few years, strengthening our specialty pharmaceutical product portfolio."
Orexigen's ex-U.S. strategy is to establish commercial and distribution partnerships in which Orexigen and the local partner share value equally. Under the terms of the ROVI agreement, ROVI will be responsible for all commercialization activity and expenses. Orexigen will supply Mysimba tablets to ROVI for an upfront fee, a transfer price, and various potential commercial milestone payments. ROVI expects to begin marketing Mysimba by year-end 2016.
Obesity and related comorbidities are a significant health problem in Spain, where approximately 53% of adults are overweight or obese, according to recent statistics from the National Health Institute.
About Pharmaceutical Laboratories ROVI, SA
Laboratorios Farmacéuticos Rovi, S.A. is an integrated and specialized Spanish pharmaceutical company engaged in the research, development, manufacturing and commercialization of small molecules and biological medical specialties, both its own pharmaceutical products and products licensed externally from companies including Servier, Novartis and Merck. ROVI has commercial expertise across therapeutic areas including endocrinology, cardiology and respiratory, among others. ROVI was founded in 1946 and reported revenues exceeding €246M in 2015.
Mysimba is approved in the European Union for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia). In the United States, the drug is approved as Contrave (naltrexone HCl / bupropion HCl extended release).
The exact neurochemical effects of Mysimba / Contrave® leading to weight loss are not fully understood. Mysimba / Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).
Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Mysimba / Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Mysimba / Contrave or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking Mysimba / Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
The clinical trial program also included a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study. The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave. A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.
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 our current beliefs and expectations. These forward-looking statements include statements regarding: the potential for the growth of the obesity problem in Spain; the potential for Mysimba to contribute to the Group's revenue in the next few years; the potential for ROVI to begin marketing Mysimba in Spain by year-end 2016. 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 potential that the marketing and commercialization of Contrave will not be successful, particularly in the U.S. following the transition from Takeda; the capabilities of our existing distribution partners and the ability to obtain partnerships and marketing authorizations globally; competition in the global obesity market, particularly from existing therapies; additional analysis of the interim results or the final data from the terminated Light Study, including safety-related data, and the additional CVOT may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; our ability to retain ownership of Contrave and Mysimba and create value in certain markets outside of the United States; our ability to adequately inform consumers about Contrave; our ability to successfully commercialize Contrave with a specialty sales force in the United States; our ability to obtain and maintain global intellectual property protection for Contrave and Mysimba; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; the therapeutic and commercial value of Contrave; our ability to successfully acquire, develop and market additional product candidates or approved products; our ability to maintain sufficient capital to fund our operations for the foreseeable future; estimates of the capacity of manufacturing and other facilities to support Contrave; the potential for a Delaware court to determine that one or more of the patents are not valid or that Actavis' proposed generic product is not infringing each of the patents at issue; 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, except as required by law. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Annual Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2016 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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