Arena Pharmaceuticals Inc., the maker of weight-loss drug Belviq, is looking for partners to sell the medicine abroad once it clears regulatory hurdles, Jack Lief, Arena’s president and CEO, said.
Belviq, approved in the United States in June as the first new obesity drug in 13 years, is being promoted in North America by Tokyo-based Eisai Co. Lief said San Diego-based Arena is in talks with other companies to promote the therapy in Europe if it gains clearance there, with a decision expected in the first half of this year.
"Europe is not partnered yet -- we’re waiting for approval," Lief said in an interview at the annual health-care conference sponsored by JPMorgan Chase & Co. in San Francisco. "We’re talking to partners presently, even at this meeting."
Lief said the biggest market outside the United States for the drug is China, and the company is looking for partners there as well.
The pill works in a similar way to fenfluramine, part of the fen-phen appetite-suppression drug combination pulled from pharmacies in 1997 when it was linked to heart valve abnormalities.
Belviq is indicated for people who have at least one coexisting condition such as high blood pressure or Type 2 diabetes. The drug will be available in the U.S. after the Drug Enforcement Administration completes a review to classify Belviq based on its potential for abuse, Arena said in an earlier statement.
Arena gained 2.2 percent to $9.20 at the close in New York. The shares have increased more than fivefold in the past 12 months.
Craig Audet, Arena’s senior vice president of operations, said the company doesn’t want the drug to be promoted just for cosmetic purposes.
"Another thing we’re really looking for is someone who looks at Belviq for medical management of obesity, and not just as a weight-loss drug," Audet said in an interview. "We don’t want someone marketing this as a cosmetic drug."
Arena turned down a company offering to promote the drug in Korea for this reason, choosing instead a less lucrative partnership with Ildong Pharmaceutical Co., Audet said.
"You can’t talk out of both sides of your mouth," Audet said.
Arena’s drug, previously known by its chemical name as lorcaserin, was rejected by the FDA in 2010 because the agency had concerns about cancer. Advisers to the agency determined the benefits of the drug outweighed the risks.
The FDA has said Arena’s pill shouldn’t be used by pregnant women. Belviq may cause serious side effects, including a fatal increase in the chemical serotonin produced by the body that can cause muscle rigidity, fever and seizures, especially when used with drugs that treat migraines and depression, the agency said. Belviq may also cause memory or attention disturbances, the FDA said.
The medication’s label also instructs patients to discontinue use if 5 percent of weight loss is not achieved by the 12th week of treatment.
Arena and Eisai agreed to conduct six post-market studies to analyst the safety and efficacy of the medicine.
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