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business newsOrexigen Steps Out of the Shadows in Obesity Race
The biotech's Contrave has a better safety profile than Vivus's Qnexa and is more effective than Arena's lorcaserin.
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Orexigen Therapeutics (OREX) announced Friday at the 70th annual American Diabetes Association meeting results from a late-stage study of its obesity drug Contrave in patients with type 2 diabetes. The data presented at the ADA conference is included in the company’s submission to the FDA.
Contrave, like Vivus’s Qnexa, is a combination of two therapies that have been on the market for years. It's made up of a sustained-release version of bupropion, also known as the anti-depressant Wellbutrin, and a sustained-release version of naltrexone, which is primarily used in the management of alcohol and drug dependence. Contrave will be scrutinized by an advisory committee to the FDA on December 7. It will face a decision for approval at the end of January 2011.
Previous mid-stage studies showed that Contrave is fairly effective (although maybe not quite as efficacious as Qnexa) and that it has a good safety profile. The results reported at the ADA meeting on Friday confirmed this. The presentation showed results from the phase III double-blind 56-week placebo-controlled study called COR-Diabetes. The trial includes 505 patients with type 2 diabetes, whose A1c levels were between 7% and 10%. A person is usually considered diabetic if their A1c level is above 6.5%, with a non-diabetic having a range of 4.5% to 6%. The ideal treatment would bring these levels down to about 7%.
COR-Diabetes was designed to help patients lose weight as well as control or improve glycemic levels. During the trial, 44% of Contrave patients reached levels of glycemic control below the 7% threshold, with 26% of placebo patients reaching these same levels. Average baseline A1c of approximately 8.0% was reduced by 0.6% for Contrave patients compared to 0.1% for placebo patients. More than twice as many patients lost at least 5% of their body weight on Contrave, 44.5%, versus patients achieving the same goal on placebo, 18.9%. Some patients went on to achieve weightloss of 10% of their bodyweight or more, with 18.5% of Contrave patients achieving this goal and only 5.7% of placebo patients getting to that point.
“We view broader improvements in metabolic health, including improved glycemic control, as compelling to the overall benefit profile of new weight loss pharmacotherapies,” wrote JMP Securities analyst Charles Duncan in a recent note to investors. “In our view, these positive data are important both in the regulatory approval process and commercial development of Contrave.”
Side effects experienced during the study were nausea, constipation, and vomiting. The completion rate of the study for Contrave patients was 52% versus 59% for placebo patients.
“It is well understood that weight loss is beneficial for glycemic control and slows disease progression in patients with type 2 diabetes,” said Dr. Hollander, a lead investigator on COR-Diabetes. “The COR-Diabetes study demonstrated the potential utility of Contrave for obese patients with diabetes, where weight loss and weight management, coupled with a clinically meaningful improvement in glycemic control, improves overall health.”
These tiny companies (none has a market cap of more than $805 million) could all benefit from the oversized market obesity presents. There are more than 72 million obese or overweight people in the US. About 20 million of those people are also diabetic -- a disease commonly associated with being overweight -- and another 1.6 million are expected to be diagnosed each year, according to the American Diabetes Association. According to a recent report by the Centers for Disease Control and Prevention, obesity-related health-care costs totaled $117 billion in 2000.
While Contrave might not be the first of these diet drugs to hit the market, it could become best in class because it shows a better safety profile than Qnexa, while being more effective than Arena’s lorcaserin.
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