Orexigen Therapeutics and Navamedic ASA to bring Mysimba to Nordic

Orexigen Therapeutics, Inc. announced that its wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., and Navamedic AB, an affiliate of Navamedic ASA, have executed a distributorship agreement covering Denmark, Finland, Iceland, Norway and Sweden for Mysimba® (naltrexone HCl / bupropion HCl prolonged release).  Navamedic ASA manufactures and markets pharmaceutical products and medical technology to patients, hospitals and pharmacies in the Nordic, Benelux and Baltic markets.

"Navamedic ASA is strongly embedded across the Nordic countries and uniquely positioned to bring Mysimba to patients in Denmark, Finland, Norway, Sweden and Iceland," said Dr. Thomas Cannell, Chief Operating Officer and President of Global Commercial Products of Orexigen.  "We have now successfully entered into partnerships covering 44 countries outside the U.S., and this latest agreement marks our fifth partnership in Europe.  With global obesity rates on the rise, we are committed to leveraging our extensive alliance management capabilities to make Mysimba available to patients who struggle to lose weight in the Nordics and around the world."

Under the partnership, Navamedic will be responsible for all commercialization activity and expenses.  Orexigen will supply Mysimba tablets to Navamedic for a negotiated transfer price and upfront milestone payments at signing and first commercialization sales.  Additional payments will be based on sales levels.  Navamedic ASA estimates that Mysimba will be available to patients in the Nordic markets by the fourth quarter of this year.

Obesity and related comorbidities are a significant health problem across the Nordic countries and the World Health Organization (WHO) predicts that obesity rates will continue to climb in this region.  According to data provided by the WHO, the percentage of the adult population struggling with obesity in these countries is: Denmark (19.3), Finland (20.4), Iceland (22.8), Norway (23.1), and Sweden (20.5).

Mysimba is approved in the European Union 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).  In the United States, the drug is approved as Contrave (naltrexone HCl / bupropion HCl extended release).

The exact neurochemical effects of Mysimba / Contrave leading to weight loss are not fully understood.  Mysimba / Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine.  Mysimba / Contrave is believed to work on two important areas of the brain – the hypothalamus (hunger center) to reduce hunger and the mesolimbic reward system to help control cravings.

Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Mysimba / Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Mysimba / Contrave or placebo.  In these studies, nearly half of patients taking Contrave lost 5% or more body weight and kept it off. (vs 23% of patients on placebo).  The most common adverse reactions (>5 percent) seen in patients taking Mysimba / Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

The clinical trial program also included a double-blind, placebo-controlled cardiovascular outcomes trial known as the Light Study.  The primary objective of this study was to evaluate the occurrence of major adverse cardiovascular events (MACE) in overweight and obese adults with cardiovascular risk factors receiving Contrave.  A second study, designed to address post-approval requirements in both Europe and the United States, is planned in order to further evaluate cardiovascular outcomes.