Valeant Canada together with its Affiliates today announced that it is entering into a commercialization and distribution agreement with Orexigen Therapeutics, Inc. for Contrave (naltrexone HCl / bupropion HCl extended release) in Canada.
Under the terms of the agreement Valeant will be responsible for obtaining Canadian regulatory approval and for all commercialization activities and expenses. Valeant expects to file with Health Canada for regulatory approval by January 2017.
“Obesity is associated with a number of health conditions” said Dr. Sean Wharton, Medical Director of the Wharton Medical Clinic in Burlington, Ontario, a community-based internal medicine weight management clinic. “In adults, abdominal obesity is associated with an increased risk of type 2 diabetes and cardiovascular disease. There is clear evidence that treating obesity leads to improvements in diabetes and risk factors for heart disease.”
Contrave was approved by the United States Food and Drug Administration in September 2014 and is indicated for use (along with restricted diet and increased exercise) in chronic weight management for persons who are obese or overweight with at least one weight-related comorbid condition.
“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.”
The strategic transaction strengthens Valeant’s Cardio-metabolic franchise in Canada and builds on its portfolio of innovative medicines, which currently includes Lodalis, Glumetza, Tiazac XC, Edarbi and Edarbyclor.
Orexigen and Valeant previously announced a commercialization agreement for Mysimba® (naltrexone HCl / bupropion HCl prolonged release) in 19 countries in Central and Easter 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.
Filed Under: Drug Discovery