Isotechnika Partner Files for Approval of Voclosporin in US and Europe

By Isotechnika Inc., PRNE
Wednesday, February 3, 2010

Trades on Toronto Stock Exchange - (TSX: ISA)

EDMONTON, Canada, February 4 - Isotechnika Pharma Inc. (TSX: ISA) today announced that its partner, Lux
Biosciences, Inc., has filed a New Drug Application (NDA) with the U.S. Food
and Drug Administration (FDA) and a Market Authorization Application (MAA)
with the European Medicines Agency (EMA) for voclosporin, under the proposed
brand name, LUVENIQ(TM). Voclosporin, a next generation calcineurin
inhibitor, is proposed for the treatment of non-infectious uveitis involving
the posterior segment of the eye, a leading cause of vision loss and
long-term disability and the fourth leading cause of legal blindness in the
industrialized world.

"Following years of hard work at Isotechnika and Lux Biosciences,
voclosporin is one step closer to approval in the United States and Europe. I
am very proud that a drug discovered in our Edmonton laboratories, almost 13
years ago, is getting closer to becoming an important new treatment for
uveitis patients," said Dr. Robert Foster, President and CEO of Isotechnika
Pharma. "The expected next step in the approval process is to receive
notification of acceptance of the dossier from the FDA and the EMA which
typically occurs within sixty days. If granted priority review by the FDA,
their objective is to complete the entire review within six months. The
review process with the EMA is typically completed in twelve months. If the
submissions are approved in the U.S. and Europe, we will receive milestone
payments of $7.04 million USD and $3.52 million USD, respectively, from Lux.
Isotechnika Pharma will also receive royalty payments on sales of voclosporin
for uveitis."

"The results seen in the LUMINATE clinical trial program, the largest
completed to date in non-infectious uveitis, support our belief that
voclosporin has the potential to significantly advance the treatment of this
blinding disease," said Dr. Ulrich Grau, Lux Biosciences' President and CEO.
"This is the first regulatory filing of voclosporin in any indication, in any
country, which made this submission a complex task. It incorporates the
research and development undertaken by Isotechnika over more than a decade,
and that of Lux Biosciences over the last 3 1/2 years."

About Isotechnika Pharma

————————

Edmonton-based Isotechnika Pharma Inc. is a 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 2011.

Voclosporin, Isotechnika Pharma's lead drug candidate, is a next
generation calcineurin inhibitor. It has completed a Phase 2b study for the
prevention of kidney rejection following transplantation and a Phase 3
European/Canadian trial for the treatment of moderate to severe psoriasis.
Our partner, Lux Biosciences, has filed dossiers for approval of voclosporin
in the U.S. and in Europe for the treatment of non-infectious uveitis. In the
U.S., Lux has been granted Fast Track designation. Lux Biosciences has also
conducted a Phase 1 trial using their proprietary voclosporin ophthalmic
solution (LX214) as a candidate for dry eye syndrome.

Isotechnika Pharma Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika Pharma can
be found at www.isotechnika.com or www.SEDAR.com.

Forward-Looking Statements

————————–

This News Release contains forward-looking statements which may not be
based on historical fact. Such forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause actual results,
events or developments to be materially different from any future results,
events or developments expressed or implied by such forward-looking
statements. Such risks and uncertainties include, among others, the Company's
belief as to the potential of its products, its ability to protect its
intellectual property rights, securing and maintaining corporate alliances
and partnerships, the need for additional capital and the effect of capital
market conditions and other factors on capital availability, the ability to
economically manufacture its products, the potential of its products, the
success and timely completion of clinical studies and trials, and the
Company's and its partners' ability to successfully obtain regulatory
approvals and commercialize voclosporin. Investors should consult the
Company's quarterly and annual filings for additional information on risks
and uncertainties relating to the forward-looking statements. These factors
should be considered carefully and readers are cautioned not to place undue
reliance on such forward-looking statements.

For further information: Dr. Robert Foster, President & CEO, Isotechnika
Pharma Inc., +1-780-487-1600-247, +1-780-484-4105 (fax),
rfoster@isotechnika.com; Dr. Launa Aspeslet, Chief Operating Officer,
Isotechnika Pharma Inc., +1-780-487-1600-225, +1-780-484-4105 (fax),
laspeslet@isotechnika.com

For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., +1-780-487-1600-247, +1-780-484-4105 (fax), rfoster at isotechnika.com; Dr. Launa Aspeslet, Chief Operating Officer, Isotechnika Pharma Inc., +1-780-487-1600-225, +1-780-484-4105 (fax),
laspeslet at isotechnika.com

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