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Arena Pharmaceuticals Initiates Second and Third Pivotal Trials Evaluating Lorcaserin for the Treatment of Obesity

Patients with FDA-defined Valvulopathy Permitted to Enroll in 2nd and 3rd Pivotal Trials – Echocardiogram Screening Requirement Eliminated

SAN DIEGO, Dec. 13 /PRNewswire-FirstCall/ — Arena Pharmaceuticals, Inc. today announced the initiation of patient screening in the second and third Phase 3 pivotal trials evaluating the efficacy and safety of its lead drug candidate, lorcaserin hydrochloride, for weight management in overweight and obese patients. Known as 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), these one-year, double-blind, randomized and placebo-controlled trials are expected to collectively enroll approximately 3,750 overweight and obese patients. Consistent with Arena’s proposal, the Food and Drug Administration, or FDA, is allowing patients with FDA-defined valvulopathy to enroll in both BLOSSOM and BLOOM-DM. This is different from the design of the initial lorcaserin pivotal study known as BLOOM, in which echocardiography was used to screen for patients with FDA-defined valvulopathy and exclude those patients from enrolling in the trial. Instead, in BLOSSOM and BLOOM-DM, there are no such echocardiographically defined exclusion criteria, although serial echocardiograms will be obtained to extend the lorcaserin safety database. BLOOM, BLOSSOM and BLOOM-DM comprise the entire planned pivotal trial program for lorcaserin.

“Eliminating the requirement of screening echoes, and receiving permission from the FDA to expand the patient population of the lorcaserin pivotal trial program to include patients with FDA-defined valvulopathy, is a significant and positive variation in the protocol for the second two pivotal trials,” commented Steven R. Smith, M.D., principal investigator in the study and Professor at the Pennington Biomedical Research Center. “This change will allow the pivotal trial program to more fully explore, and develop a more complete understanding of, lorcaserin’s selective mechanism and its safety profile.”

“Given the prevalence and impact of obesity, patients and their physicians need new treatment options,” commented Lee M. Kaplan, M.D., Ph.D., an investigator in the BLOOM, BLOOM-DM and BLOSSOM pivotal trials, Director of the Massachusetts General Hospital Weight Center and Associate Professor of Medicine at Harvard Medical School. “Including a broader representation of overweight patients and patients with obesity as part of the pivotal trial program for lorcaserin, including individuals with more significant valvulopathy and type 2 diabetes, is important for providing a more complete assessment of the safety and efficacy of this agent,” concluded Dr. Kaplan.

The BLOSSOM trial will evaluate 10 mg and 20 mg daily doses (10 mg dosed once or twice daily) of lorcaserin versus placebo over a one-year treatment period in obese patients (Body Mass Index, or BMI, 30 to 45) with or without co-morbid conditions and overweight patients (BMI 27 to 29.9) with at least one co-morbid condition at about 100 sites in the United States. The BLOOM-DM trial will evaluate 10 mg and 20 mg daily doses of lorcaserin versus placebo over a one-year treatment period in obese and overweight patients with type 2 diabetes mellitus at about 45 sites in the United States.

Consistent with the BLOOM trial, diet and exercise will also be included in the BLOSSOM and BLOOM-DM trials in accordance with current FDA guidelines, and the proportion of patients with a 5% or greater weight reduction from baseline at week 52 will be the primary efficacy endpoint. Secondary endpoints include changes in serum lipids 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.