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Isotechnika Pharma announced that its partner, Lux Biosciences has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market Authorization Application (MAA) with the European Medicines Agency (EMA) for voclosporin, under the proposed brand name, LUVENIQ(TM)
EDMONTON, AB, CANADA | February 4, 2010 | Isotechnika Pharma Inc. (TSX: ISA) today announced that its partner, Lux Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and a Market 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 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.
"Following years of hard work at Isotechnika and Lux Biosciences, voclosporin is one step closer to approval in the United States and Europe. I am very proud that a drug discovered in our Edmonton laboratories, almost 13 years ago, is getting closer to becoming an important new treatment for uveitis patients," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "The expected next step in the approval process is to receive notification of acceptance of the dossier from the FDA and the EMA which typically occurs within sixty days. If granted priority review by the FDA, their objective is to complete the entire review within six months. The review process with the EMA is typically completed in twelve months. If the submissions are approved in the U.S. and Europe, we will receive milestone payments of $7.04 million USD and $3.52 million USD, respectively, from Lux. Isotechnika Pharma will also receive royalty payments on sales of voclosporin for uveitis."
"The results seen in the LUMINATE clinical trial program, the largest completed to date in non-infectious uveitis, support our belief that voclosporin has the potential to significantly advance the treatment of this blinding disease," said Dr. Ulrich Grau, Lux Biosciences' President and CEO. "This is the first regulatory filing of voclosporin in any indication, in any country, which made this submission a complex task. It incorporates the research and development undertaken by Isotechnika over more than a decade, and that of Lux Biosciences over the last 3 1/2 years."
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 exceed $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2011.
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.
Isotechnika Pharma Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.SEDAR.com.
SOURCE: Isotechnika Pharma Inc. |
