Lux Biosciences files NDA with FDA and MAA with EMA for approval of voclosporin

Feb 4 2010

Isotechnika Pharma Inc. (TSX: ISA) today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM). Voclosporin, a next generation calcineurin inhibitor, is proposed for the treatment of non-infectious uveitis involving the posterior segment of the eye, a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world.

"Following years of hard work at Isotechnika and Lux Biosciences, voclosporin is one step closer to approval in the United States and Europe. I am very proud that a drug discovered in our Edmonton laboratories, almost 13 years ago, is getting closer to becoming an important new treatment for uveitis patients," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "The expected next step in the approval process is to receive notification of acceptance of the dossier from the FDA and the EMA which typically occurs within sixty days. If granted priority review by the FDA, their objective is to complete the entire review within six months. The review process with the EMA is typically completed in twelve months. If the submissions are approved in the U.S. and Europe, we will receive milestone payments of $7.04 million USD and $3.52 million USD, respectively, from Lux. Isotechnika Pharma will also receive royalty payments on sales of voclosporin for uveitis."

"The results seen in the LUMINATE clinical trial program, the largest completed to date in non-infectious uveitis, support our belief that voclosporin has the potential to significantly advance the treatment of this blinding disease," said Dr. Ulrich Grau, Lux Biosciences' President and CEO. "This is the first regulatory filing of voclosporin in any indication, in any country, which made this submission a complex task. It incorporates the research and development undertaken by Isotechnika over more than a decade, and that of Lux Biosciences over the last 3 1/2 years."