Orexigen Therapeutics announces new drug submission for Contrave in Canada

Orexigen Therapeutics, Inc., a biopharmaceutical company helping to improve the health and lives of patients struggling with weight loss, announced that Health Canada has completed its screening phase and accepted for review a New Drug Submission for marketing approval of Contrave. The regulatory submission was filed by Valeant Canada, an affiliate of Valeant Pharmaceuticals International, Inc. If approved, Valeant will market and distribute Contrave in Canada as part of its distributorship agreement with Orexigen, executed in August 2016.

"We are excited about achieving this important step toward making Contrave available for patients in Canada," said Dr. Thomas Cannell, Chief Operating Officer and President of Global Commercial Products of Orexigen. "We look forward to leveraging our strong alliance management capabilities to support Valeant's commercialization in the Canadian market."

Under the terms of the agreement, Valeant is responsible for obtaining regulatory approval and for all commercialization activity and expenses. Valeant expects to begin marketing Contrave in the first half of 2018, if regulatory approval is obtained.

According to data from Statistics Canada, obesity and related comorbidities continue to be a growing problem in Canada, with almost two thirds of Canadian adults either overweight or struggling with obesity. Estimates of the economic burden of obesity in Canada range from $4.6 billion to $7.1 billion annually.1

Orexigen has partnerships to commercialize Contrave and Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in a total of 39 countries worldwide, including partnerships with Valeant in Canada, Australia, New Zealand, South Africa and 21 European countries.