Recently Orexigen Therapeutics, Inc. (OREX) received a boost when the US Food and Drug Administration (FDA) accepted the New Drug Application for its candidate Contrave (naltrexone SR/bupropion SR). The candidate, a combination therapy, aims to address physiological and behavioral causes of obesity.
The substantial amount of evidence gathered through the Contrave Obesity Research (COR) clinical program formed the basis of the application filed by the company in March 2010. The COR program studied more than 4,500 patients.
The COR late-stage program had four randomized, double-blind, placebo-controlled studies. The proportion of patients who achieved at least 5% weight loss and percent change in body weight compared to placebo formed the co-primary endpoints. Multiple measures of cardiometabolic risk, life quality, diet and glycemic control were included as secondary endpoints.
In March 2010, Orexigen and Patheon Inc. not only agreed to commercially manufacture Contrave but also develop future formulations of Orexigen products.
However, we note that Orexigen is not the only company seeking to develop a treatment for obesity. Companies like Amylin Pharmaceuticals, Inc. (AMLN), Arena Pharmaceuticals (ARNA) and VIVUS, Inc. (VVUS) are all striving to bring obesity treatments to market. Arena’s Lorcaserin, VIVUS’ Qnexa as well as Contrave work by affecting the patient’s central nervous system thereby dampening the appetite.
Recently, Amylin Pharmaceuticals and partner Takeda Pharmaceutical Co. Ltd. announced that they intend to advance their obesity combination treatment of pramlintide and metreleptin into late-stage studies.
Obesity is an attractive market that could be worth many billions of dollars. It is estimated that obesity affects over 400 million people globally. Moreover, obesity is linked to increased health risk of several medical conditions. Given the huge unmet need in this market, the successful development of the obesity pipeline would help drive growth at Orexigen.
Read the full analyst report on “OREX”
Read the full analyst report on “VVUS”
Read the full analyst report on “AMLN”
Read the full analyst report on “ARNA”
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