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Arena slips after lorcaserin data

November 10, 2010 12:27 AM UTC

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) was off $0.05 to $1.48 on Tuesday as investors weighed whether new data for obesity candidate lorcaserin in patients with Type II diabetes would satisfy requests made by FDA in an October complete response letter. In the Phase III BLOOM-DM trial, twice-daily lorcaserin met all three primary endpoints vs. placebo at week 52 (p<0.0001 for all): proportion of patients who lost at least 5% body weight from baseline (37.5% vs. 16.1%); mean weight loss (4.5% vs. 1.5%); and proportion of patients who lost at least 10% body weight from baseline (16.3% vs. 4.4%).

The serotonin (5-HT2C) receptor agonist also met the secondary endpoints of significantly reducing HbA1c and fasting glucose from baseline to week 52 vs. placebo. The data included 509 patients in a modified intent-to-treat (mITT) last observation carried forward (LOCF) analysis. Arena plans to meet with FDA by year end to discuss the complete response letter, in which the agency said that the efficacy of lorcaserin in patients without Type II diabetes is "marginal" and recommended that Arena submit the final report from the BLOOM-DM trial. The two Phase III trials upon which the lorcaserin NDA was based -- BLOSSOM and BLOOM -- excluded patients with Type II diabetes. Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) has marketing rights to lorcaserin in the U.S. ...