FDA Advisory Committee planned to review Lux Biosciences' NDA for voclosporin

May 13 2010

Isotechnika Pharma Inc. today announced that the Dermatology and Ophthalmology Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review partner, Lux Biosciences', New Drug Application (NDA) for voclosporin on June 28, 2010. Voclosporin is proposed for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye.

Lux submitted its NDA on February 4, 2010, seeking approval to market voclosporin in the United States. The FDA accepted the NDA filing for review and granted the NDA priority review on March 30, 2010. The target Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review is August 3, 2010. The FDA is not bound by the Advisory Committee's recommendation, but may take its advice into consideration when evaluating the NDA for voclosporin.

"With the meeting of the Dermatology and Ophthalmology Drugs Advisory Committee confirmed for June 28, 2010 and the PDUFA date of August 3, 2010, we look forward to value-driving news events in the third quarter, as well as a potential milestone payment of $7.04 million USD, followed by royalty payments on sales in the United States," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "The review process in Europe is also underway and expected to be completed by the end of February 2011. If approved, we also look forward to an additional milestone payment and royalty payments for sales of voclosporin in Europe."