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Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity
Date:12/13/2007

ids and HbA1c and, in the BLOOM-DM trial, other indicators of glycemic control will also be evaluated. In both of these additional studies, all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the ongoing BLOOM trial, however, there will be no independent monitoring by an Echocardiographic Safety Monitoring Board. The complete lorcaserin Phase 3 pivotal program is planned to enroll a total of approximately 7,000 patients in these three trials. In addition to the planned pivotal trial program, several additional small studies, such as drug interaction and abuse potential studies, will be conducted.

"As we continue advancing our lorcaserin clinical program, we are looking forward to March 2008 when we expect the BLOOM Echocardiographic Safety Monitoring Board's review of echocardiograms for patients completing 12 months of treatment. We will continue to work with the FDA as we implement the final non-pivotal trial elements of the complete Phase 3 program," stated William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer.

An earlier estimate of the total external clinical costs of the Phase 3 trial program was updated from approximately $125 million to approximately $160 million. The increased estimate is primarily due to the increased number of patients Arena plans to enroll, and to Arena's initiative to expand the echocardiographic monitoring program by including patients with FDA-defined valvulopathy in the BLOSSOM and BLOOM-DM trials.

About Lorcaserin

Lorcaserin, Arena's internally discovered oral drug candidate for the treatment of obesity, is in an ongoing Phase 3 program. The compound stimulates the 5-HT2C serotonin receptor, located in the hypothalamus, an area of the brain associated with the control of satiety and metabolism. Results from Phase 2 studies demonstrated that treatment with lorcaserin produced highly sta
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SOURCE Arena Pharmaceuticals, Inc.
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