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Positive Data from Arena Pharmaceuticals' Pivotal BLOOM Trial Demonstrate that Lorcaserin Significantly Improved Markers of Cardiovascular Risk and Glycemic Parameters and was not Associated with Depression or Suicidal Ideation
Date:10/25/2009

on or suicidal ideation. Lorcaserin's selective activation of an important receptor associated with reduced food intake avoids these liabilities. We believe the data presented at Obesity 2009 will support our new drug application and we look forward to working with the FDA to provide physicians and patients with lorcaserin."

Previously announced BLOOM data demonstrate that lorcaserin helped patients achieve clinically meaningful weight loss and maintenance of weight loss over two years of treatment. In the per protocol population, nearly two-thirds (66.4%) of lorcaserin patients lost at least 5% of their weight, compared to 32.1% of patients on placebo, and over one-third (36.2%) of lorcaserin patients lost at least 10% of their weight, compared to 13.6% for placebo. The average weight loss in this population was 17.9 pounds in the lorcaserin group, compared to 7.4 pounds in the placebo group. Using ITT-LOCF analysis, 67.9% of Year 1 lorcaserin responders maintained at least 5% weight loss during Year 2, compared to 50.3% for those patients re-randomized from lorcaserin treatment in Year 1 to placebo in Year 2.

Lorcaserin improved patients' lipid profiles, insulin resistance and markers of inflammation, with the greatest improvements observed in those with abnormal values at the start of the study. Treatment with lorcaserin was well tolerated, resulting in very few adverse events with greater frequency than the placebo group, and did not increase cardiac valvulopathy. Lorcaserin's tolerability profile eliminates the need for titration; patients began treatment on the full dose and achieved rapid weight loss. Almost one-third of lorcaserin patients lost at least 5% of their body weight by Week 8.

Patient Disposition

BLOOM evaluated 3,182 patients with an average BMI of 36.2 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin (55.4%) compared to patients on placebo (45
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SOURCE Arena Pharmaceuticals, Inc.
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