The pharmaceutical company consolidates its leadership position in the field of Cardio-metabolic diseases in Canada
LAVAL, QC, Aug. 30, 2016 /CNW Telbec/ - 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.
Valeant Canada is a subsidiary of Valeant Pharmaceuticals International Inc., a multinational specialty pharmaceutical company that develops, manufactures, and markets a broad range of pharmaceutical products, primarily in the areas of dermatology, eye health, cardio-metabolic, and neurology. More information about Valeant Canada can be found at www.valeantcanada.com.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen's first product, Contrave® (naltrexone HCl and bupropion HCl extended release), was approved in the United States in September 2014 and became the most prescribed branded obesity medication in the United States in June 2015. In Europe, the drug has been approved under the brand name Mysimba® (naltrexone HCl/ bupropion HCl prolonged release). Orexigen is undertaking a range of development and commercialization activities, both on its own and with strategic partners, to bring Contrave / Mysimba to patients around the world. Further information about Orexigen can be found at www.orexigen.com
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).
SOURCE Valeant Canada
For further information: Sebastien Beauchamp, Valeant Canada LP, 514-744-6792, firstname.lastname@example.org