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Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results for Weight Management; NDA Submission on Track for December
Date:9/17/2009

36.2% 13.6% 35.1% 26.3% 16.1% ---------------- ---- ---- ---- ---- ---- >/=10% weight loss (ITT-LOCF) 22.6% 7.7% 22.6% 17.4% 9.7% ---------------- ---- --- ---- ---- --- Mean weight loss (Per protocol) 8.2% 3.4% 7.9% 6.5% 3.9% ------------- --- --- --- --- --- Mean weight loss (ITT-LOCF) 5.8% 2.2% 5.9% 4.8% 2.8% --------- --- --- --- --- --- * p<0.0001 compared to placebo

"Lorcaserin demonstrated consistent results in the BLOOM and BLOSSOM trials, which together evaluated nearly 7,200 patients for up to two years," said William R. Shanahan, M.D., Arena's Vice President and Chief Medical Officer. "These results support lorcaserin's potential to meet the need for a safe, effective and well-tolerated weight loss medication. There are only two drugs that are approved by the FDA for long-term treatment, and new mechanistic and better tolerated approaches could greatly improve the treatment of patients who are obese or significantly overweight."

Safety and Tolerability Profile

Lorcaserin was very well tolerated. No adverse event rate in the lorcaserin group exceeded the placebo group by more than 4%. The most frequent adverse events and their rates for patients who took lorcaserin twice daily, lorcaserin once daily or placebo, respectively, were as follows: upper respiratory infection (12.7%, 14.5%, 12.6%); nasopharyngitis (12.5%, 11.7%, 11.8%) and headache (10.0%, 10.5%, 7.6%).

Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group. Serious adverse events, or SAEs, occurred infrequently: one deat
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SOURCE Arena Pharmaceuticals, Inc.
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