NDA filed, at lastEDMONTON, Feb. 4 /CNW/ - Isotechnika Pharma Inc. (TSX:
ISA -
News) todayannounced that its partner, Lux Biosciences, Inc., has filed a New DrugApplication (NDA) with the U.S. Food and Drug Administration (FDA) and aMarket 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 thetreatment of non-infectious uveitis involving the posterior segment of theeye, a leading cause of vision loss and long-term disability and the fourthleading 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. Iam very proud that a drug discovered in our Edmonton laboratories, almost 13years ago, is getting closer to becoming an important new treatment foruveitis patients," said Dr. Robert Foster, President and CEO of IsotechnikaPharma. "The expected next step in the approval process is to receivenotification of acceptance of the dossier from the FDA and the EMA whichtypically occurs within sixty days. If granted priority review by the FDA,their objective is to complete the entire review within six months. The reviewprocess with the EMA is typically completed in twelve months. If thesubmissions are approved in the U.S. and Europe, we will receive milestonepayments of $7.04 million USD and $3.52 million USD, respectively, from Lux.Isotechnika Pharma will also receive royalty payments on sales of voclosporinfor uveitis."
"The results seen in the LUMINATE clinical trial program, the largestcompleted to date in non-infectious uveitis, support our belief thatvoclosporin has the potential to significantly advance the treatment of thisblinding disease," said Dr. Ulrich Grau, Lux Biosciences' President and CEO."This is the first regulatory filing of voclosporin in any indication, in anycountry, which made this submission a complex task. It incorporates theresearch and development undertaken by Isotechnika over more than a decade,and that of Lux Biosciences over the last 3 1/2 years."