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FDA Sets Decision Date for Arena’s Obesity Drug

San Diego-based Arena Pharmaceuticals Inc. said on Jan. 10 that the Food and Drug Administration has accepted its resubmitted New Drug Application for its investigational obesity pill lorcaserin, with approval decision set for June 27.

The company also said it expects to raise $33 million through a stock offering of more than 10 million shares, which it will use mainly for working capital to bring lorcaserin to market. “All attention at Arena is focused on doing what is necessary to obtain approval in the U.S. and Europe,” a spokesman said.

Arena also said it plans to use $5 million of the sale proceeds to repay a portion of a loan to Deerfield Management Co., a New York-based health care investment group. The closing of the stock offering is expected to take place on or before Jan. 13, Arena said in a document filed Jan. 11 with the Securities and Exchange Commission.

The clinical-stage company will be selling 9.95 million shares of common stock at $1.66 per share and 9,953 shares of preferred stock priced at $1,657.75 per share.

Lorcaserin is Arena’s most advanced investigational drug candidate, having already gone through two phase 3 clinical trials. The weight-loss therapy targets the area of the brain believed to control appetite and metabolism. The FDA has rejected the drug in the past due to possible cancer risks.

Arena’s subsidiary Arena Pharmaceuticals GmbH has granted Woodcliff Lake, N.J.-based drug company Eisai Inc. exclusive rights to commercialize lorcaserin in the U.S. pending FDA approval.

There are limited drug options to help patients lose weight, yet obesity is a growing health problem. According to the Centers for Disease Control and Prevention, about one-third of U.S. adults are obese. Studies have shown that a weight loss of 5 percent to 10 percent of body weight can improve heart-risk factors and lower the incidence of type 2 diabetes, Arena said.

Arena trades on Nasdaq under the symbol ARNA. Shares were at $1.68 early on Jan. 11, down about 4 percent from the previous day’s closing price.

— Kelly Quigley


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