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.