- Published: 06 October 2008
- Written by Editor
Isotechnika announces first sale of commercial supply of voclosporin
Isotechnika Inc. (ISA:TSX) today announced the first sale of voclosporin API (active pharmaceutical ingredient) for commercial use to its partner, Lux Biosciences, Inc. Lux Biosciences has licensed the global rights to all ophthalmic indications from Isotechnika and has made an initial payment of US$2 million under a commercial supply agreement previously executed between the companies. Three separate clinical (LUMINATE) trials are currently investigating LUVENIQ(TM) as a corticosteroid-sparing agent for the treatment of patients with non-infectious uveitis, an autoimmune disease characterized by chronic inflammation of the eye and one of the leading causes of blindness. Lux Biosciences' plan is to launch LUVENIQ(TM) in 2010, subject to successful completion of the LUMINATE trials and regulatory approval.
"Our partner, Lux Biosciences, has significantly advanced the clinical development LUVENIQ(TM) for the eventual commercial launch in the treatment of uveitis," said Clemens Kaiser, Isotechnika's Chief Marketing Officer. "This is the first commercial supply of voclosporin to our partner and obviously a significant milestone event for Isotechnika. It is great to see that we are now measuring progress in material sales as well as clinical milestones."
<< About Isotechnika ----------------- >>
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. 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 2010.
Voclosporin is a next generation calcineurin inhibitor, which recently completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. An extension to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQ(TM) by Lux) for the treatment of uveitis. Voclosporin has also entered First-in-Man trials as the drug utilized in the CINATRA(TM) Drug Coated Coronary Stent system developed by the Company's partner, Atrium Medical Corporation.
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 or www.SEDAR.com.
<< About Uveitis ------------- >>
Uveitis is an autoimmune disease characterized by chronic inflammation of the eye. Uveitis is an under-diagnosed and under-recognized medical condition that causes vision impairment, ocular pain, and loss of vision. Experts estimate that 10% of new cases of blindness in the U.S. result from this disease. Approximately 300,000 people suffer from uveitis in the United States alone, the majority of whom are affected by anterior uveitis; Lux Biosciences is targeting roughly a third of the disease population for potential treatment. The only therapeutic class approved by the FDA for treatment of uveitis is corticosteroids, which are burdened with multiple side effects, such as osteoporosis, hyperglycemia, hypercholesterolemia, hypertension, mood disturbances, and if applied chronically to the eye, cataract formation and glaucoma.
<< Forward-Looking Statements -------------------------- >>
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.
%SEDAR: 00010508E
SOURCE: Isotechnika Inc.
Stephanie Gillis-Paulgaard, Director, Corporate Communications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780) 484-4105, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.