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Isotechnika Inc.

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.
About ISA247
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.
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 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.
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.

Contact:

For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600-(247), Fax: +1-780-484-4105,
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Phone: +1-780-909-4661,
Fax: +1-780-484-4105, sgillis-paulgaard@isotechnika.com; Lux
Biosciences, Inc., Ulrich Grau, Ph.D., Phone: +1-201-946-0221,
ulrich.grau@luxbio.com

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