Cipher Pharmaceuticals enrolls first patient in Phase III study of CIP-ISOTRETINOIN

Cipher Pharmaceuticals Inc.Oct 7 2009

Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has enrolled the first patient in its Phase III safety study of CIP-ISOTRETINOIN, the Company's novel, patented formulation of isotretinoin, which is used in the treatment of severe, nodular acne.

The study is randomized, double-blinded trial comparing the safety profile of CIP-ISOTRETINOIN to an FDA-approved, commercially available isotretinoin product. The study will be conducted at 50 sites in the U.S. and Canada, and is expected to enroll more than 800 patients over an 18-month period. The study is being conducted under a Special Protocol Assessment ("SPA") that was granted by the U.S. Food and Drug Administration ("FDA").

In the clinical studies that formed the basis of its New Drug Application with the FDA, CIP-ISOTRETINOIN demonstrated significantly more consistent absorption under variable dietary conditions compared with existing isotretinoin products on the market. To achieve optimal absorption, current isotretinoin formulations are prescribed to be taken with meals, which proves to be a compliance challenge for many teenagers. CIP-ISOTRETINOIN uses the patent-protected Lidose(R) drug delivery system, which delivers super-bioavailability for relatively water-insoluble compounds. Cipher was issued a patent for CIP-ISOTRETINOIN by the United States Patent and Trademark Office in 2008.

"We are pleased to reach this clinical development milestone for our novel isotretinoin formulation," said Larry Andrews. "Isotretinoin is the most effective treatment for severe, nodular acne. We believe this product's unique attributes, particularly the more consistent absorption profile, would provide a significant advancement in the treatment of severe acne and offer dermatologists an excellent alternative. We look forward to working closely with our U.S. marketing partner, Ranbaxy Pharmaceuticals, as we advance this final clinical study and prepare for the commercialization of the product in the $700 million U.S. isotretinoin market."

As previously disclosed, Ranbaxy Pharmaceuticals is reimbursing Cipher for all costs associated with the clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally. Cipher is responsible for all product development activities, including management of the clinical studies required by the FDA to secure NDA approval.