Orexigen Therapeutics, Inc. (NASDAQ: OREX) today announced Valeant Pharmaceuticals International, Inc. will commercialize Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Central and Eastern Europe. The distribution agreement between Valeant Holdings Ireland and Orexigen's wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., includes 12 countries where Mysimba has been approved for marketing in the European Union (EU): Greece, Slovenia, Slovakia, Czech Republic, Hungary, Croatia, Lithuania, Estonia, Poland, Latvia, Bulgaria, and Romania. The agreement also extends to several non-EU countries where Valeant will apply for marketing authorization: Serbia, Bosnia and Herzegovina, Albania, Macedonia, Montenegro, Kosovo and Turkey. Orexigen expects Valeant to launch in the 12 EU countries in the second half of this year.
Under the terms of the agreement, Valeant will be responsible for commercialization activities in all 19 countries and for obtaining regulatory approvals in the non-EU countries. Orexigen will retain regulatory affairs responsibilities in EU countries. Orexigen will supply Mysimba tablets to Valeant at an agreed transfer price.
"Earlier this year, we announced that our commercial strategy outside the United States is to partner with strong local and regional pharmaceutical companies with demonstrated capabilities and relevant relationships, who we believe will maximize sales of Contrave® / Mysimba," said Mike Narachi, CEO of Orexigen. "With a broad and growing regional franchise of primary care and specialty medicines, Valeant is an ideal distribution partner for Mysimba in Central and Eastern Europe."
"Obesity is a rapidly growing problem in Central and Eastern Europe, where the World Health Organization estimates the proportion of adults with a BMI greater than 30 now approaches 20%," said Graham Jackson, Vice President and General Manager of Valeant Holdings Ireland. "We believe that Mysimba is uniquely positioned to meet this significant medical need and will complement our existing portfolio of primary care offerings."
Orexigen today separately announced the strategic acquisition of all U.S. rights to Contrave (naltrexone HCl / bupropion HCl extended release), the leading market branded anti-obesity prescription medicine. The acquisition is subject to the parties' receipt of clearance under the Hart-Scott-Rodino Antitrust Improvement Act. Upon completion of the acquisition, Orexigen will own all rights to Contrave in nearly all global territories.