Isotechnika Receives USAN Approval for Generic Name for Lead Immunosuppressive Drug
Edmonton, Canada (ots/PRNewswire)
Isotechnika Inc. announced today that the Company has received approval from United States Adopted Name (USAN) for naming of its lead immunosuppressive drug, ISA247.
The name, voclosporin, is now being reviewed by the International Nonproprietary Name (INN) expert committee. The INN is scheduled to publish the proposed list of approved names sometime in mid 2007. Official notification from the INN would allow Isotechnika to use the name voclosporin in labelling, publications, and on drug information. The name will serve to identify the active pharmaceutical substance during the drugs' life-time worldwide.
ISA247 (voclosporin) is a calcineurin inhibitor, currently being investigated in a Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis and a Phase 2b North American trial for the prevention of organ rejection in kidney transplant patients and as a treatment for uveitis in three separate pivotal Phase 2/Phase 3 trials. The latter trial is being coordinated by our partner, Lux Biosciences.
"Moving toward the name of voclosporin from the previous nomenclature of ISA247 should assist us in initiating our commercial branding process. The next step in the naming process is to request that the USAN approved name, voclosporin, be approved by the International Nonproprietary Name (INN) Programme of the World Health Organization (WHO). Pending receipt of this INN approval, ISA247 will, in all future materials, be referred to by its new generic name, voclosporin," commented Dr. Randall Yatscoff, Isotechnika's President & CEO.
About Isotechnika
Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world-class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 has successfully completed a Phase 3 Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a combined Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which successfully completed Phase 1 clinical trials.
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 voclosporine 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 voclosporine 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 voclosporine 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, voclosporine 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.
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Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc.,+1(780)-487-1600-(246), +1(780)-484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1(780)-487-1600-(243),
+1(780)-487-4105 (fax), sgillis-paulgaard@isotechnika.com (ISA.)