EDMONTON, Canada, February 4 /PRNewswire/ -- Isotechnika Pharma Inc. 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
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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 http://www.isotechnika.com or http://www.SEDAR.com.
Forward-Looking Statements
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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.
For further information: Dr. Robert Foster, President CEO, Isotechnika Pharma Inc., +1-780-487-1600-247, +1-780-484-4105 (fax), rfoster@isotechnika.com; Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., +1-780-487-1600-225, +1-780-484-4105 (fax), laspeslet@isotechnika.com
SOURCE: Isotechnika Inc.
CONTACT: For further information: Dr. Robert Foster, President CEO,Isotechnika Pharma Inc., +1-780-487-1600-247, +1-780-484-4105 (fax),rfoster@isotechnika.com; Dr. Launa Aspeslet, Chief Operating Officer,Isotechnika Pharma Inc., +1-780-487-1600-225, +1-780-484-4105 (fax),laspeslet@isotechnika.com
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