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news.Orexigen Therapeutics' wholly owned subsidiary Orexigen Therapeutics Ireland and Laboratorios Farmacéuticos Rovi, S.A. (ROVI) have executed a commercialization and distributorship agreement for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in Spain.
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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.