Chicago, IL 3/30/12 (StreetBeat) – Arena Pharmaceuticals Inc. (Nasdaq: ARNA) and Vivus Inc. (Nasdaq: VVUS), competing to win U.S. regulatory approval for weight-loss treatments, probably won’t be affected by an advisory panel’s recommendation for heart-risk studies, a Food and Drug Administration spokeswoman said.The panel voted 17-6 yesterday in Silver Spring, Maryland, to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes. The panel’s goal was to help the agency update guidelines for bringing obesity treatments to market, Erica Jefferson, a spokeswoman for the FDA, said in an e-mail today.
“It’s unlikely that the discussions over the past couple days will impact any existing applications,” Jefferson said.
Vivus, Arena and a third California-based company, Orexigen Therapeutics Inc. (Nasdaq: OREX), are racing to bring the first weight-loss pill to market in 13 years. The fen-phen appetite-suppression drug combination was pulled from pharmacies 15 years ago when it was linked to heart-valve abnormalities.
Vivus rose 7.5 percent to $22.88 at 9:43 a.m. New York time. Arena increased 1.6 percent to $3.09 and Orexigen fell 3.5 percent to $4.38.
The FDA is set to make a decision on Mountain View, California-based Vivus’s drug Qnexa by April 17. San Diego-based Arena’s treatment lorcaserin faces an advisory panel May 10, with the agency expected to make a decision by June 27.
Orexigen agreed in September with the FDA to conduct a two- year study of heart risks for the drug Contrave. The La Jolla, California-based company is a partner with Takeda Pharmaceutical Co. (4502), based in Osaka, Japan.
Two-Tiered Studies
Panel members agreed studies should be two tiered: pre- and post-approval. Companies should rule out a certain degree of risk during pre-approval and further prove the drugs don’t cause excessive heart harm after the medicines are on the market, advisers said during discussion. The FDA isn’t required to follow the panel’s guidance.
The panel voted Feb. 22 that Qnexa’s benefits outweigh its risks. Sanjay Kaul, a professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member, said the treatment works the best to help patients lose weight, giving it a good chance of the FDA requiring post-approval studies on heart risk instead of additional ones before.
The last obesity drug the FDA approved was Roche Holding AG (Pinksheets: RHHBY)’s Xenical in 1999.Abbott Laboratories (NYSE: ABT) withdrew its obesity treatment Meridia in 2010 after a post-market trial revealed a 16 percent increase in risk of heart attack or stroke in those taking the product over those using a placebo and little difference in weight loss.
Arena is studying its compound lorcaserin to assess cancer risks. The company is in a partnership with Tokyo’s Eisai Co. (4523)
The FDA previously has rejected all three drugs, asking for more data on safety risks, including the likelihood of birth defects associated with Qnexa.
More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.
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Chicago, IL 3/30/12 (