Isotechnika's Uveitis Treatment Gets FDA Fast Track
EDMONTON, Aug. 7 - Isotechnika announced today that the Food and Drug Administration (FDA) of the United States granted fast track designation for the Company's lead drug, ISA247 under section 506 of the Federal Food, Drug and Cosmetic Act. The FDA based its decision on the following reasons:
- ISA247 is intended for the treatment of a serious or life-threatening condition, namely non-infectious posterior, intermediate and panuveitis, and - ISA247 demonstrates the potential to address medical needs unmet by available treatments for non-infectious posterior, intermediate and panuveitis.
Fast Track designation will provide various means to expedite the development and review of ISA247. The process could be facilitated through meetings and other correspondence with the FDA reviewers, consideration for priority review, and the ability to submit portions of the New Drug Application (NDA) early for review as part of a "rolling" submission. "Thanks to the FDA's approval for Fast-Track designation, we have the potential to more rapidly deliver to patients a much needed drug for uveitis," comments Ulrich Grau, PhD, president and chief executive officer of Lux Biosciences. "If successful, LX211 (referred to as ISA247 by Isotechnika) would be the first thoroughly tested and approved steroid-sparing therapy for the treatment of uveitis.""We are extremely excited that Lux received Fast-Track designation for ISA247 for the treatment of uveitis," stated Dr. Randall Yatscoff, Isotechnika's president & chief executive officer. "We are continually encouraged by the broad potential use of ISA247 in transplantation, psoriasis, and uveitis."
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. Enrollment for the LUMINATE trial program is expected to be completed by early 2008 and, if successful, Lux plans to seek regulatory approval for LX211 in late 2008. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis.
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 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 $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.
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.