Orexigen Therapeutics, Inc. announced that Valeant Canada, a subsidiary of Valeant Pharmaceuticals International, Inc., or its affiliates, will commercialize Contrave (naltrexone HCl / bupropion HCl extended release) in Canada. Under the terms of the agreement between Valeant and Orexigen's wholly owned subsidiary Orexigen Therapeutics Ireland Ltd., Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activity and expenses.
Orexigen will supply Contrave tablets to Valeant Canada or its affiliates for an agreed transfer price and certain potential regulatory and sales milestone payments. Orexigen expects Valeant to file with Health Canada for regulatory approval by January 2017.
"Valeant Canada has a growing portfolio of innovative medicines addressing cardiometabolic disease, as well as strong regulatory and commercial capabilities, and we believe they are an ideal partner for Contrave in Canada," said Mike Narachi, CEO of Orexigen. "Partnering with strong pharmaceutical companies outside the United States supports our global mission to improve the health and lives of patients struggling to lose weight and allows Orexigen to realize the global value of Contrave / Mysimba."
"Our agreement with Orexigen will bring long-term value to one of our key growth platforms," said Richard Lajoie, vice-president of the Pharma Business Unit at Valeant Canada. "This addition to our portfolio helps us to offer an even broader range of innovative treatments to physicians and weight management specialists for patients suffering from obesity."
Obesity and related comorbidities are a growing problem in Canada, with almost two thirds of Canadian adults now either overweight or obese, according to recent data from Statistics Canada. Estimates of the economic burden of obesity in Canada range from $4.6 billion to $7.1 billion annually.
Orexigen and Valeant previously announced a commercialization agreement for Mysimba (naltrexone HCl / bupropion HCl prolonged release) in 19 countries in Central and Eastern Europe in March 2016. Orexigen and Valeant anticipate launching Mysimba in 11 countries in the fourth quarter of 2016, to be followed by two additional countries in the first quarter of 2017.
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 diarrhea.