SAN DIEGO, July 26, 2017 /PRNewswire/ -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that its wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Biologix FZCO have amended the commercialization and distributorship agreement for Contrave® (naltrexone HCl / bupropion HCl extended release) in the Middle East to include Egypt.
With the addition of Egypt, the agreement now spans 11 countries in the Middle East: Egypt, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates. While Orexigen will continue to own marketing authorization, Biologix will represent Orexigen in local product registrations and will also be responsible for commercialization activities for all 11 countries. Orexigen will supply Contrave to Biologix at an agreed transfer price.
Orexigen also announced that regulatory applications have been submitted in Kuwait, Lebanon, Saudi Arabia and United Arab Emirates and expects Contrave to be available for patients in these four countries starting in the first quarter of 2018.
"As our existing partner with a well-established presence in the Middle East and North Africa, Biologix is uniquely positioned to also bring Contrave to patients in Egypt," said Dr. Thomas Cannell, Chief Operating Officer and President of Global Commercial Products of Orexigen. "With the addition of Egypt, we have successfully entered into partnerships covering 45 countries to support the worldwide commercialization of Contrave, and we are committed to leveraging our alliances management capabilities to help combat the global rise of obesity rates."
"We look forward to leveraging our expertise in Egypt to bring Contrave to patients struggling with weight loss and obesity," said Selim Ghorayeb, Chief Executive Officer of Biologix FZCO. "We are pleased that Orexigen continues to place its trust in us as its partner in the Middle East and North Africa."
Obesity and related comorbidities are a significant health problem in Egypt, which currently leads as the country with the highest prevalence of adults struggling with obesity in the world, and where an estimated 51% of women and 33% of men are struggling with obesity. [i],[ii]
About Biologix FZCO
Biologix FZCO is a leading promoter and distributor of Biotech products in the MENA region, which is based in Dubai, UAE. Biologix 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 Algeria, Egypt, Bahrain, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Qatar, Saudi Arabia, Tunisia, UAE and Yemen. 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 FDA 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).
Orexigen is committed to helping eligible patients learn about Contrave and recommends patients visit www.contrave.com for additional information.
For more information and full prescribing information please visit www.contrave.com.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of weight loss and obesity. The company's mission is to help improve the health and lives of patients struggling to lose weight. Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the U.S. in September 2014. In the European Union, the medicine has been approved under the brand name Mysimba™ (naltrexone HCl / bupropion HCl prolonged release). Millions around the globe continue to face challenges of weight loss. 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. As a patient-centric company, Orexigen continues to focus not only on innovating medicine for the treatment of obesity, but to also offer unique resources and healthcare delivery options to improve the patient experience. 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 Kuwait, Lebanon, Saudi Arabia and United Arab Emirates and other Middle East countries; and the expectation for additional ex-U.S. commercial alliances in the future. 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; 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; the therapeutic and commercial value of Contrave; our ability to retain ownership of Contrave and create value in certain markets outside of the United States; legal or regulatory proceedings against Orexigen; our ability to maintain sufficient capital to fund our operations for the foreseeable future; 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 May 12, 2017 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.
i Ibrahim et al. Cut off values of waist circumference and associated cardiovascular risk in Egyptians. BMC Cardiovasc Disord; 11:53. August 16, 2011.
ii GBD 2015 Obesity Collaborators. Health Effects of Overweight and Obesity in 195 Countries over 25 Years. N Engl J Med; 377:13-27. July 6, 2017.
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