NEW YORK – Shares of Orexigen Therapeutics Inc. jumped Monday after the company said a European Union review of its weight loss drug Contrave, which was approved in the U.S. in September, is progressing on schedule.
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Orexigen said it still having talks with an advisory committee about Contrave. It will send the committee more information about the drug in November and expects the group to give its opinion in December. Orexigen wants to market the drug in Europe under the name Mysimba.
Orexigen also reported better-than-expected quarterly results, and its shares picked up 69 cents, or 17.9 percent, to $4.54 in morning trading.
The U.S. Food and Drug Administration approved Contrave in September after more than two years of delays. Regulators were concerned about the effect of the drug on patients' cardiovascular systems, and asked Orexigen to do more research into the issue.
Contrave is a combination of two drugs that are already approved: naltrexone, which is used to treat alcohol and narcotic dependence, and bupropion, an antidepressant also used to help people quit smoking. The drug will be distributed in the U.S. by Japanese drugmaker Takeda Pharmaceuticals, which will pay Orexigen royalties on sales. Orexigen and Takeda plan to start selling the drug this fall.
Takeda paid Orexigen $30 million in the third quarter after approval as it got ready to launch Contrave, and Orexigen says it received another $70 million early in the fourth quarter.
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The La Jolla, California, company reported a profit of $11.3 million, or 9 cents per share, in the third quarter on revenue of $30.9 million.
Zacks Investment Research says analysts expected net income of 5 cents per share.
A year ago Orexigen posted a loss of $18.6 million, or 19 cents per share, on revenue of $857,000.
Contrave is the third weight loss drug to be approved in recent years. The FDA approved Vivus Inc.'s Qsymia and Arena Pharmaceuticals Inc.'s Belviq in 2012, but sales of both products have been far below expectations due to limited insurance coverage and high out-of-pocket costs for patients.
Elements of this story were generated by Automated Insights using data from Zacks Investment Research. OREX stock research report from Zacks.
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