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FDA Advisory Panel OKs Arena Pharma Diet Pill Lorcaserin

Arena Pharmaceuticals, Inc. (ARNA) and Eisai Inc. announced that the US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee voted 18 to 4, with one abstention, that the available data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.

Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI greater than or equal to 30) or patients who are overweight (BMI greater than or equal to 27) and have at least one weight-related co-morbid condition.

The company said that although advisory committees provide recommendations to the FDA, the agency makes the final decisions. The Prescription Drug User Fee Act (PDUFA) date for the lorcaserin New Drug Application or NDA resubmission is June 27, 2012, which is the target date for the agency to complete its review.

In a separate press release, Arena Pharmaceuticals and Eisai announced the expansion of the lorcaserin marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc.

In addition to the United States, the territories in the expanded agreement now include most of North and South America, including Canada, Mexico and Brazil. This expansion builds on the agreement executed by Eisai and Arena in July 2010 for Eisai's exclusive rights to market and distribute lorcaserin in the United States, subject to lorcaserin's approval by the US Food and Drug Administration.

As per the original deal, Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution, subject to applicable regulatory approvals in the territories.

Under the expanded agreement, Arena is eligible to receive increased payments based upon Eisai's net sales of lorcaserin in the United States and expanded North and South American territories. Additionally, Arena will receive an upfront payment and is eligible to receive regulatory and development milestone payments.

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