Cipher Pharmaceuticals Inc. (TSX: DND; OTC: CPHMF.PK) announced today that the U.S. Food and Drug Administration (FDA) has approved Absorica™, Cipher's novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne. Absorica is expected to be launched in the U.S. in Q4 2012.
"Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our Scientific Affairs team at Cipher and our partner, Galephar Pharmaceutical Research," said Larry Andrews, President and CEO of Cipher. "We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force."
"We are thrilled to make Absorica available as a valuable option for the dermatologist and patients who need treatment for severe recalcitrant nodular acne. Absorica is a critical milestone in our commitment to serve the dermatology community and will be the flagship brand for Ranbaxy's specialized dermatology sales force," said Venkat Krishnan, Senior Vice President and Regional Director, Americas.
As a result of the FDA approval of Absorica, Cipher will receive a US$9.0 million milestone from Ranbaxy, approximately US$4.5 million of which will be shared with Galephar. This milestone will be reflected in Cipher's cash balance at the end of Q2 2012. Going forward, Cipher will also receive royalties on net U.S. sales and is eligible for future milestone payments based on sales targets. Under the agreement with Ranbaxy, Cipher is responsible for product supply and manufacturing.
Cipher Pharmaceuticals Inc.