Orexigen Therapeutics Announces Commercialization and Distributorship Agreement with Bruno Farmaceutici S.p.A.

Orexigen Therapeutics, Inc. announced that its wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Bruno Farmaceutici S.p.A. (Bruno) have executed a distributorship agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in Italy.  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).  Bruno manufactures and markets pharmaceutical products including drugs for treatment of diabetes.

“Bruno Farmaceutici S.p.A. is an outstanding partner to bring Mysimba to the Italian market,” said Mike Narachi, CEO of Orexigen.  “This agreement, our fourth partnership in Europe, brings us into another major European market.  As we continue to advance our ex-U.S. commercialization strategy, we now have partnerships in a total of 39 countries worldwide and strong alliance management capabilities to support our partners in bringing Contrave® and Mysimba to patients who struggle to lose weight.”

Under the terms of the agreement, Bruno will be responsible for all commercialization activity and expenses.  Orexigen will supply Mysimba to Bruno for a negotiated transfer price and upfront milestone payments at signing and first commercial sale.  Additional payments will be based on sales levels.  Bruno expects that Mysimba will be available for patients in Italy in the fourth quarter of this year.

Obesity and related comorbidities are a significant health problem in Italy, where over 40% of adults are overweight or struggle with obesity, according to the Organisation of Economic Co?operation and Development (OECD)1.  The World Health Organization2 predicts that obesity rates will continue to climb in Italy.