Biotech Stock News: Orexigen’s Obesity Drug Contrave Approved, Stock Set to Rise High

Biotech Finance News

Orexigen Therapeutics, Inc. finally gained FDA approval for its weight loss drug, Contrave (NB32, naltrexone hydrochloride and bupropion hydrochloride extended-release tablets). We expect investors to react positively to the news.

The FDA cleared Contrave as an adjunct to a healthy diet (low on calories) and physical activity for chronic weight management in obese (Body Mass Index, or BMI, ≥ 30) or overweight (BMI ≥ 27) adults suffering from at least one weight-related co-morbid condition including high blood pressure, type II diabetes and high cholesterol.

The FDA stated that patients receiving the maintenance dose of Contrave should be evaluated after 12 weeks and the drug should be discontinued in those patients who have failed to lose at least 5% of baseline body weight. Contrave will carry a boxed warning related to increased risk of suicidal thoughts and behavior associated with antidepressants like bupropion.

Biotech Stock News

Orexigen is also looking to get Contrave approved in Europe. A recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use is expected after the review of the Day 180 List of Questions.

We note that the company has a collaboration agreement with Takeda Pharmaceutical Company Limited for the development and commercialization of Contrave in North America. Takeda has experience in the metabolic disorder market, which should be beneficial. The companies have started preparations for the launch of Contrave with approximately 900 sales representatives.

Orexigen has rights to Contrave outside North America and is looking for a partner to commercialize Contrave in ex-North America territories.

Biotech Financial News

Contrave, once launched, will enter a highly crowded obesity market with products like Qsymia and Belviq. However, given the Light study data on Contrave, expectations remain high that the product will most likely be more successful than currently available obesity treatments.

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