SAN DIEGO, Dec. 19, 2016 /PRNewswire/ -- Orexigen Therapeutics, Inc. (NASDAQ: OREX) today announced that its wholly owned subsidiary Orexigen Therapeutics Ireland Ltd. and Biologix FZCO, have executed a commercialization and distributorship agreement in the Middle East for Contrave® (naltrexone HCl / bupropion HCl prolonged release) monotherapy for weight management in overweight or obese adult patients.
This agreement covers ten countries in the Middle East: Saudi Arabia, the United Arab Emirates, Kuwait, Oman, Qatar, Bahrain, Lebanon, Jordan, Iraq and Iran. Under the terms of the agreement, Biologix will be responsible for obtaining regulatory approvals and local product registrations in each of the ten countries and for all commercialization activities. Orexigen will supply Contrave to Biologix at an agreed transfer price. Biologix expects Contrave to be available for patients in some countries starting in the third quarter of 2017.
"Biologix's strong commercial capabilities and their extensive experience in the cardio-metabolic therapeutic area makes them an ideal partner to bring Contrave to multiple countries in the Middle East as a differentiated new treatment option to address the significant and growing problem of obesity," said Michael Narachi, CEO of Orexigen. "We have significantly advanced our ex-U.S. commercial strategy by establishing relationships with seven local and regional partners covering 38 countries around the world to support the drug's commercialization. We look forward to progressing with these alliances in 2017."
"We are looking forward to our partnership with Orexigen and are dedicated to using our experience to help bring Contrave to patients struggling with weight loss and obesity," said Selim Ghorayeb, CEO of Biologix.
Obesity and related comorbidities are a significant health problem in the Middle East and North Africa (MENA) region. An estimated 58.5% of men and 65.5% of women in the MENA region are overweight or obese. Rates of overweight and obesity are particularly high in the Arabian Gulf States where, on average, 67% of men and 73% of women are overweight or obese.i Kuwait, Bahrain, Saudi Arabia and United Arab Emirates are on the World Health Organization's list of top ten countries worldwide in terms of obesity.ii
About Biologix FZCO
Biologix FZCO is a leading promoter and distributor of Biotech products in the MENA region, based in Dubai, UAE. It offers Regulatory, Medical, Marketing, Sales and Distribution support to its partners with a direct presence in 16 countries of the Middle East and North Africa including Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar, Yemen, Iran, Iraq, Lebanon, Jordan, Egypt, Libya, Tunisia, Algeria, and Morocco. Biologix focuses on the following therapeutics areas: Oncology-Hematology, Cardio-metabolic, Neurology and Rare Diseases. It owns and operates a logistics hub with cold chain capabilities in the Dubai Airport Free Zone.
CONTRAVE, approved by the United States Food and Drug Administration in September 2014, is indicated 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).
Please see Important Safety Information including boxed warnings for suicidal thoughts and behaviors and neuropsychiatric reactions for Contrave below. Access the full prescribing information and learn more about Contrave at www.contrave.com.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014 and became the most prescribed branded obesity medication in the United States in June 2015. In the European Union, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring Contrave / Mysimba to patients around the world. Further information about Orexigen can be found at www.orexigen.com
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 regulatory approvals and local product registrations for Contrave in the Middle East; the potential for and timing of commercialization of Contrave in the Middle East; and the expectation to progress with our ex-U.S. commercial alliances in 2017. 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.; 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 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.
Chief Financial Officer
Orexigen Therapeutics, Inc.
BrewLife (Media Contact for Orexigen)
i Ng, Marie et al. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014 Aug 30;384(9945):766-81.
ii Al Nohair, Sultan. Obesity in Gulf Countries. Int J Health Sci (Qassim). 2014 Jan; 8(1): 79–83.
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