BioCentury
ARTICLE | Clinical News

Cip-isotretinoin regulatory update

January 2, 2012 8:00 AM UTC

Cipher said FDA accepted an amendment to an NDA for Cip-isotretinoin to treat severe, nodular acne. The agency designated the amendment a Class 2 resubmission, with a PDUFA date of May 29. The amendment, submitted late last year, contains data from a Phase III trial designed to address safety concerns the agency raised in a 2007 approvable letter (see BioCentury, May 7, 2009 & Dec. 5, 2011).

The acceptance of the amendment triggered a $1 million milestone payment to Cipher from Ranbaxy Laboratories Ltd. (NSE:RANBAXY; BSE:500359, Gurgaon, India), which has an exclusive license from Cipher to market Cip-isotretinoin in the U.S. to treat acne (see BioCentury, Aug. 18, 2008). Cipher licensed Cip-isotretinoin from Galephar Pharmaceutical Research Inc. (Juncos, Puerto Rico), which is eligible to receive 50% of the milestone and royalty payments Cipher receives from Ranbaxy. ...