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EMEA Committee Recommends Orphan Medicinal Product Designation for ISA247 for the Treatment of Uveitis
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today that the European Agency for the Evaluation of Medicinal Products (EMEA) committee for Orphan Medicinal Products has adopted a positive opinion on orphan medicinal product designation for ISA247 for the treatment of chronic, non-infectious uveitis. The EMEA will now forward the opinion to the European Commission. The Decision will be adopted by the Commission within 30 days of its receipt. Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, fee reductions and free Scientific Advice.
Isotechnika's partner, Lux Biosciences, began enrolling patients in pivotal clinical trials for ISA247 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis.
Isotechnika's lead drug, ISA247, is a calcineurin inhibitor to which Lux Biosciences has an exclusive worldwide license for ophthalmic indications. ISA247 is currently being investigating in a combined European/Canadian Phase 3 psoriasis trial and in a North American Phase 2b kidney transplant trial. In addition to uveitis, Lux Biosciences plans to develop this molecule in other ophthalmic indications, including dry eye syndrome and age-related macular degeneration. Lux Biosciences was previously granted orphan drug status for ISA247 by the FDA in USA.
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments while offering therapeutic choices to clinicians. Isotechnika looks to become the market leader of drug therapies for indications such as transplantation of solid organs (with Hoffman La Roche) and treatment of autoimmune disorders such as uveitis (with Lux Biosciences) and psoriasis.
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 exceeds US$2 billion annually in sales for calcineurin inhibitors such as ISA247.
Isotechnika's lead drug, ISA247, has successfully completed a Phase 3 Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection subsequent to transplantation.
Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika can be found at www.isotechnika.com.
Partnerships with Isotechnika Inc.
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche on April 9, 2002, which licensed the worldwide rights to develop and commercialize ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into an exclusive worldwide licensing agreement with Atrium Medical Corporation for the use of ISA247 and TAFA93 specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular, target vessel and tissue disorders.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive license to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of ISA247 in patients suffering from mild to moderate psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.ch
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600-(247), Fax: +1-780-484-4105,
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Phone: +1-780-909-4661,
Fax: +1-780-484-4105, email@example.com; Lux
Biosciences, Inc., Ulrich Grau, Ph.D., Phone: +1-201-946-0221,