Orexigen Therapeutics, Inc. announced that Valeant Pharmaceuticals International, Inc. (Valeant), through a wholly owned subsidiary, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Australia and New Zealand.

Under the terms of the agreement between Valeant and Orexigen's wholly owned subsidiary, Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining regulatory approvals and for all commercialization activities. Orexigen will supply Contrave tablets to Valeant for an agreed transfer price and certain potential sales milestone payments. Orexigen expects Valeant to file for regulatory approvals in both countries in the first half of 2017.

"We are pleased to work with Valeant to bring Contrave to Australia and New Zealand, where treatment options for patients struggling to lose weight are currently limited," said Mike Narachi, chief executive officer of Orexigen. "Our commercial strategy outside the United States is to realize the global value of Contrave / Mysimba through partnerships with strong local and regional pharmaceutical companies. Valeant's capabilities in consumer marketing and prescription medicine distribution make them a strong partner for Orexigen in Australia and New Zealand."

"Obesity is a rapidly growing problem in Australia and New Zealand," said Scott Hirsch, Senior Vice President of Strategy of Valeant. "The Australian Institute for Health and Welfare estimates nearly two in three adults are overweight or obese. We believe that Contrave is uniquely positioned to meet this significant medical need and will complement our existing portfolio of prescription medicines."

Orexigen and Valeant Pharmaceuticals International, Inc. previously announced commercialization agreements for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in 20 countries in Central and Eastern Europe and for Contrave in Canada and South Africa.

Contrave, approved by the United States Food and Drug Administration 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).

The exact neurochemical effects of Contrave leading to weight loss are not fully understood. Contrave has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).

Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of Contrave in conjunction with lifestyle modification in 4,536 subjects randomized to Contrave or placebo. In these studies, the most common adverse reactions (>5 percent) seen in patients taking Contrave included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth and diarrhoea.

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity.