Orexigen Therapeutics, Inc. ( OREX ) announced encouraging updates on its weight loss drug, Mysimba. The company said that last week it has received minutes from the December meeting with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the approval of Mysimba.
The CHMP provided a positive opinion on the approval of the drug with 31 out of 33 member states giving the nod. The company also said that the marketing authorization for Mysimba will be reviewed in a meeting of the Standing Committee in March this year.
We note that the drug is currently under review in the EU as an adjunct to a reduced-calorie diet and physical activity for chronic weight management in obese (Body Mass Index, or BMI, ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2) adults suffering from at least one weight-related co-morbid condition including type II diabetes, dyslipidaemia or controlled hypertension.
Mysimba is already available in the U.S. under the trade name Contrave from Oct 2014. The drug was approved in the U.S. in Sep 2014.
We note that the company has a collaboration agreement with Takeda Pharmaceutical Company Ltd. ( TKPYY ) for the development and commercialization of Contrave in North America.
We are encouraged by Orexigen's progress with Mysimba. With the drug already launched in the U.S., a EU approval will further boost its sales potential.
However, the obesity market already has products like Qsymia and Belviq. It will be interesting to see how Mysimba/Contrave competes with these products. We expect investor focus to remain on the drug going forward.
Orexigen carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Alnylam Pharmaceuticals, Inc. ( ALNY ) and Biogen Idec Inc. ( BIIB ). Both stocks hold a Zacks Rank #2 (Buy).
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