FDA approves Celgene's Revlimid

FDA approved CELG's Revlimid lenalidomide to treat myelodysplastic syndromes (MDS) with 5q chromosomal deletion late on Tuesday, more than a week before the Jan. 7 PDUFA date. In October, the agency extended the PDUFA date by three months from Oct. 7 to review information on CELG's RevAssist risk management program. An MAA for the thalidomide analog is under review for the same indication. The company intends to submit an sNDA this week for Revlimid to treat multiple myeloma (MM) and plans to submit an MAA in Europe for MM in the first quarter. Revlimid has Orphan Drug designation for MDS in the U.S. and the EU and for MM in Europe.

CELG, which expects to launch Revlimid in 2006, reduced its 2005 EPS guidance to $0.36-$0.38 from $0.55 to account for pre-launch expenses. The Street was expecting 2005 EPS of $0.54. Also, CELG's board approved a 2-for-1 split of the company's 170 million shares outstanding for shareholders of record as of Feb. 17, 2006. CELG will begin trading on a split-adjusted basis on Feb. 27, 2006. ...