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Study Results Emerge; Arena Shares Dip, Kick Up

Arena Pharmaceuticals said Sept. 18 its weight loss drug candidate lorcaserin succeeded in a final trial that sets the stage for its upcoming FDA application, although the drug’s effectiveness appeared to trail the competition.

Shares of Arena, traded under the symbol ARNA on the Nasdaq, fell 12 percent to $4.30 in early trading Sept. 18. Its stock quickly reversed midday, however, after Arena executives said they felt the results would be enough to gain FDA approval. Shares were up 14 percent at $5.59.

Arena’s year-long trial of 4,000 patients found that those taking lorcaserin twice a day lost an average of 5.9 percent of their body weight, compared with 2.8 percent for patients taking a placebo , a difference of 3.1 percentage points.

Given those results, Arena did not appear to meet one of two FDA recommended goals for obesity drugs: that patients taking a drug experience average weight loss of at least 5 percentage points higher than placebo.

Alternatively, the FDA says a study can demonstrate that at least 35 percent of those taking the drug lose at least 5 percent of their body weight, but that group must be approximately double the percentage of patients with similar weight loss on the placebo.

Arena’s study showed that 47 percent on the twice-daily drug lost at least 5 percent of their body weight, compared with 25 percent in the placebo group.

Earlier this month, Bay Area biotech Vivus impressed investors when it reported results from a 3,750-patient trial showing it met both of the FDA’s benchmarks. Its shares soared 70 percent on the news to close at $11.90 Sept. 9.

Arena is racing Vivus to file an FDA application at the end of the year. Orexigen Therapeutics, also of San Diego, said earlier this year it doesn’t expect to file an application until next year.

, Heather Chambers

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