New drug application for voclosporin accepted for priority review by FDA
EDMONTON, March 30 /CNW/ - Isotechnika Pharma Inc. (TSX: ISA) today announced that the New Drug Application (NDA) for the Company's next generation calcineurin inhibitor, voclosporin, has been accepted for priority review as filed by the U.S. Food and Drug Administration (FDA). The application was submitted by Isotechnika's partner, Lux Biosciences, Inc.
The FDA granted voclosporin with a priority review status which accelerates the review period to six months. The FDA grants a priority review designation to drugs that are considered to have the potential to provide an important advancement in treatment or provide a treatment for which there is no adequate therapy available. The target date under the 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 have additional validation to the technology, as well as two very important milestones 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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%SEDAR: 00028600EFor further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 (247), (780) 484-4105 (fax), firstname.lastname@example.org; Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., (780) 487-1600 (225), (780) 484-4105 (fax), email@example.com