DEA classifies Belviq

Arena Pharmaceuticals Inc. (NASDAQ:ARNA) gained $0.82 (11%) to $8.34 on Tuesday after the U.S. Drug Enforcement Agency issued a final rule establishing twice-daily obesity drug Belviq lorcaserin as a class IV controlled substance -- in line with its proposed and FDA's requested classification. Class I indicates the highest potential for abuse and class V the lowest. U.S. marketing partner Eisai Co. Ltd. (Tokyo:4523; Osaka:4523) said it will launch the drug in the U.S. with wholesale acquisition cost (WAC) of $199.50 for a one-month supply on June 7, when DEA's final rule takes effect. The launch will trigger a $65 million milestone payment to Arena from Eisai, which had requested that DEA allow Belviq to be available immediately instead of 30 days after Belviq's final classification. DEA, however, said the 30-day delay is "both expeditious and sufficient" for class IV controlled substances. FDA approved Belviq last June (see BioCentury Extra, Dec. 26, 2012).

Last week, Arena disclosed in its 1Q13 financial results that it is withdrawing an MAA from EMA for Belviq after EMA's CHMP requested the company "further justify" the overall benefit-risk balance of the serotonin (5-HT2C) receptor agonist (see BioCentury Extra, May 2). ...