Lux gets priority reviewNew drug application for voclosporin accepted for priority review by FDA
EDMONTON, March 30/CNW/ - Isotechnika Pharma Inc. (TSX: ISA) today announced that the NewDrug Application (NDA) for the Company's next generation calcineurininhibitor, voclosporin, has been accepted for priority review as filedby the U.S. Food and Drug Administration (FDA). The application wassubmitted by Isotechnika's partner, Lux Biosciences, Inc.
The FDA granted voclosporin with a priority review status whichaccelerates the review period to six months. The FDA grants a priorityreview designation to drugs that are considered to have the potentialto provide an important advancement in treatment or provide a treatmentfor which there is no adequate therapy available. The target date underthe Prescription Drug User Fee Act (PDUFA) is August 3, 2010.
"With an active regulatory review process by both the FDA and the EMA, a PDUFA date of August 3rd,and potential EMA approval in the first quarter of 2011, we now haveadditional validation to the technology, as well as two very importantmilestones over the next eleven months to drive value in Isotechnika,"said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "FDA approval would result in a milestone payment of $7.04 million USD followed by royalty payments on sales from our partner, Lux. On the back of that we can expect an additional $3.52 million milestone payment from Lux for approval by the EMA, followed by royalty payments."
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