European authorities accept voclosporin for regulatory review
Trades on Toronto Stock Exchange - (TSX: ISA)
EDMONTON, March 2 /CNW/ - 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."
About Isotechnika Pharma ------------------------
Edmonton-based Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will be $2.95 billion annually in sales for calcineurin inhibitors such as voclosporin in 2010.
Voclosporin, Isotechnika Pharma's lead drug candidate, is a next generation calcineurin inhibitor. It has completed a Phase 2b study for the prevention of kidney rejection following transplantation and a Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis. Our partner, Lux Biosciences, has filed dossiers for approval of voclosporin in the U.S. and in Europe for the treatment of non-infectious uveitis. In the U.S., Lux has been granted Fast Track designation. Lux Biosciences has also conducted a Phase 1 trial using their proprietary voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome.
Forward-Looking Statements --------------------------
This News Release contains forward-looking statements which may not be based on historical fact. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the Company's belief as to the potential of its products, its ability to protect its intellectual property rights, securing and maintaining corporate alliances and partnerships, the need for additional capital and the effect of capital market conditions and other factors on capital availability, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, and the Company's and its partners' ability to successfully obtain regulatory approvals and commercialize voclosporin. Investors should consult the Company's quarterly and annual filings for additional information on risks and uncertainties relating to the forward-looking statements. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements.
%SEDAR: 00028600EFor further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 ext. 247, (780) 484-4105 (fax), firstname.lastname@example.org; Dr. Launa J Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., (780) 487-1600 ext. 225, (780) 484-4105 (fax), email@example.com