EDMONTON, Aug. 1 /CNW/ - 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)
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
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
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
For further information:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: (780) 487-1600 (247), Fax: (780) 484-4105,
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780) 484-4105,
email@example.com; Lux Biosciences, Inc., Ulrich Grau, Ph.D.,
Phone: (201) 946-0221, firstname.lastname@example.org