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New Data Analyses from Lorcaserin Phase 3 Clinical Trials to be Presented at Obesity 2011
Date:9/26/2011

in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover lorcaserin in the United States and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.

Arena submitted a New Drug Application (NDA) for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010. Arena's wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.

Lorcaserin Phase 3 Clinical Trial Program OverviewThe lorcaserin Phase 3 clinical trial program consists of three double-blind, randomized, placebo-controlled trials – BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) and BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) – that together enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in obese patients or overweight patients with at least one weight-related co-morbid condition. BLOOM evaluated 3,182 patients over a two-year treatment period, and BLOSSOM evaluated 4,008 patients over a one-year treatment period. BLOOM-DM evaluated 604 obese and overweight patients with type 2 diabetes over a one-year treatment period. The trials included a standardized program of moderate diet and exercise guidance.

About Arena PharmaceuticalsArena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major th
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SOURCE Arena Pharmaceuticals, Inc.
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