Mar 2 2010
Isotechnika Pharma Inc. (TSX: ISA) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) filed by its partner, Lux Biosciences, Inc., for voclosporin. Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review, which is expected to take one year.
In this application, 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.
"With the EMA acceptance of the dossier we now expect the review process to be completed by the end of February 2011. With approval, this will result in a milestone payment of $3.52 million USD and royalty payments on sales from our partner, Lux," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "We also expect to hear about the acceptance of our dossier by the FDA by April. If, based on its orphan drug status and the request of Lux, it is granted priority review, the objective of the FDA is to complete the review within six months. With approval, we would receive another milestone of $7.04 million USD followed by royalty payments."
Source:
ISOTECHNIKA PHARMA INC.