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Cipher Pharma's Novel Formulation Of Acne Medication Gets FDA Approval

Cipher Pharmaceuticals Inc. (DND.TO, CPHMF.PK) said the U.S. Food and Drug Administration 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 the fourth quarter of 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."

As a result of the FDA approval of Absorica, Cipher will receive a $9.0 million milestone from Ranbaxy, approximately $4.5 million of which will be shared with Galephar. This milestone will be reflected in Cipher's cash balance at the end of the second quarter, 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.

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