CIP-ISOTRETINOIN, which is based on the Lidose® drug delivery system, is used in the treatment of severe acne. In Phase I clinical studies, Cipher's innovative formulation demonstrated a significant competitive advantage in the treatment of severe, recalcitrant nodular acne. CIP-ISOTRETINOIN provides more consistent absorption under fed and fasted conditions compared with existing isotretinoin products on the market.
In May 2006, Cipher received an approvable letter from the U.S. Food and Drug Administration (FDA) pertaining to its New Drug Application (NDA) for CIP-ISOTRETINOIN. Cipher submitted its response in October 2006 and received a second approvable letter in April 2007. To obtain final FDA approval, Cipher is conducting a Phase III safety study. The 800-patient study is a double-blind, randomized trial comparing CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study began enrollment in the third quarter of 2009, and is being conducted in the U.S. and Canada over an 18-month period.
In August 2008, Cipher achieved a major milestone with the completion of a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. (“RPI”), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States.
