Arena slips on lorcaserin update
Arena Pharmaceuticals Inc. (NASDAQ:ARNA) fell $0.24 (12%) to $1.80 on Wednesday after announcing plans to resubmit an NDA for obesity candidate lorcaserin by the end of 2011. Arena made the announcement after meeting with FDA to discuss issues outlined in an October complete response letter, including mammary tumors and brain astrocytomas seen in rats. On a conference call, Arena said it believes FDA will accept prolactin release as a viable mechanism for the cause of the mammary tumors and that prolactin-mediated mammary tumors are irrelevant to humans. The company plans to conduct studies in female rats to demonstrate persistent increases in serum prolactin. Arena will also conduct rat studies and a clinical trial in about 10 healthy volunteers to asses the risk for brain astrocytoma. Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) has rights to market the serotonin (5-HT2C) receptor agonist in the U.S. Pre-approval costs are split 50/50 between Eisai and Arena.
Among other companies developing compounds for obesity, Orexigen Therapeutics Inc. (NASDAQ:OREX) was off $0.16 to $8.24 on Wednesday, while Vivus Inc. (NASDAQ:VVUS) was off $0.16 to $9.59. Earlier this month, a panel voted 13-7 that the benefit-risk profile of Orexigen's Contrave supports approval as a long-term treatment for obesity. The fixed-dose combination of naltrexone and bupropion has a Jan. 31 PDUFA date. ...