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Arena Submits Response to FDA Complete Response Letter for Lorcaserin
Date:1/3/2012

ed 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 the original NDA for lorcaserin in December 2009, and the FDA issued a CRL in October 2010. Arena submitted a response to the lorcaserin CRL in December 2011, and it expects that in January 2012 the FDA will assign a new PDUFA date. 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, and enrolled approximately 7,800 patients. BLOOM and BLOSSOM evaluated lorcaserin versus placebo in patients who are obese or patients who are overweight and have 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 therapeutic areas: cardiovascular, central nervous system, inflammator
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