Orexigen Revives Obesity Drug Development With FDA Agreement
Orexigen Therapeutics Inc. (OREX) is renewing development of the experimental obesity drug Contrave after reaching an agreement with U.S. regulators to further study heart risks. The company’s shares jumped more than 85 percent in extended trading after its announcement.
Orexigen, one of three companies with rival obesity treatments competing for approval, will start a two-year clinical trial of about 10,000 patients in the first half of next year, aiming to receive clearance for Contrave from the Food and Drug Administration in 2014, the La Jolla, California- based company said today in a statement.
“It’s very positive news,” Michael Narachi, Orexigen president and chief executive officer, said in an interview. “This drug, which we always believed could benefit patients, has a clear path to market.”
Orexigen announced June 3 it would halt U.S. development of Contrave after the FDA said a large study on heart risks would be required before the drug could be approved -- a move the company called “unprecedented.”
Orexigen and partner Takeda Pharmaceutical Co. of Osaka, Japan, has been vying with Mountain View, California-based Vivus Inc. (VVUS) and Arena Pharmaceuticals Inc. (ARNA) of San Diego to introduce the first new obesity medicine in the U.S. in more than a decade.
Shares Rise
Orexigen gained $1.27, or 86 percent, to $2.74 at 5:56 p.m. New York time in extended trading after the company’s shares were unchanged at $1.47 at the close of Nasdaq Stock Market composite trading. Arena rose as much as 17 percent to $1.69 and Vivus increased as much as 5.5 percent to $9.10 in extended trading.
Orexigen’s shares had declined 75 percent in the past 12 months.
Last week, the FDA agreed to reconsider Vivus’s drug, Qnexa, for the treatment of obese men and women who don’t have the potential for having children. Under the agreement, Vivus will resubmit Qnexa by the end of next month, with the FDA scheduling an advisory panel in the first quarter of next year. A final decision on whether the drug is approved would come in the second quarter of 2012, Vivus said.
Arena’s medicine, lorcaserin, was rejected by the FDA last October. The agency requested more data after a rat study showed a possible link to brain tumors. The company and its development partner Tokyo-based Eisai Co. said in August that a study showed concentrations of their weight-loss pill were lower in human brains than in rat models.
Seeking Partner
Contrave’s study won’t have the same patient restrictions as Vivus’s Qnexa, Narachi said. The company, which had $70 million in cash at the end of the last quarter, will look for a partner to help shoulder the cost of the new trial, in exchange for commercial rights outside of North America.
Previous studies showed that two Contrave tablets taken two times a day helped twice as many patients in studies lose at least 5 percent of their weight compared with a placebo after 56 weeks, meeting one of two FDA guidelines for approval of diet pills. The product is a combination of two marketed drugs that target different parts of the brain influencing appetite and cravings.
Contrave increases blood pressure, a risk seen with Abbott Laboratories pill Meridia. The agency pulled Meridia from the market last year after it was tied to heart attacks and strokes.
While the FDA is planning to ask an advisory committee to review the general requirements for heart safety and diet bills, any recommendations won’t affect the agency’s agreement with Orexigen on Contrave, the company said in its statement.
“Assuming success of this cardiovascular outcomes trial, I can’t think of a stronger way to launch a product into this space,” Mark Booth, chief commercial officer, said today during a conference call with analysts. “The efficacy of Contrave would be supported by a significant safety trial that would provide patients and physicians with a great deal of confidence.”
To contact the reporter on this story: Ryan Flinn in San Francisco at rflinn@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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