Isotechnika's Partner, Lux Biosciences, Receives Orphan Drug Designation for Ophthalmic Indications of ISA247

Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA)
announced today that its partner, Lux Biosciences, has been granted
orphan drug designation from the U.S. Food and Drug Administration
(FDA) for ISA247, referred to as LX211 by Lux, for the treatment of
non-infectious posterior, intermediate and panuveitis.

Orphan drug designation is a special status for diseases or
conditions affecting fewer than 200,000 patients in the United
States, granted by the FDA upon request by a sponsor. Orphan drug
designation qualifies the sponsor for exclusive marketing rights in
the United States for seven years if the Company is first to receive
marketing approval. The designation also positions Lux Biosciences
to benefit from certain tax credits and waives the company's
obligation to pay FDA application user fees for these products as
required by the Prescription Drug User Fee Act (PDUFA).

"We are pleased to receive Orphan Drug designation from the FDA
for LX211 (ISA247), a late-stage product in our pipeline," said
Ulrich Grau, President and CEO of Lux Biosciences. "LX211 has the
potential of establishing new treatment paradigms in these an
indication of high medical need. The only drugs currently approved
in uveitis are steroids."

Dr. Randall Yatscoff, Isotechnika's President & CEO stated, "The
receipt of Orphan Drug designation for non-infectious uveitis may
facilitate the introduction of ISA247 (LX211) for treatment of these
serious disorders."

About Uveitis

-------------

Uveitis is an autoimmune disease characterized by chronic
inflammation of the eye. There is substantial evidence implicating
T-lymphocytes, key cells involved in inflammatory processes, in the
development of the disease . Uveitis is an under-diagnosed and
under-recognized medical condition that causes vision impairment,
ocular pain, and loss of vision. Experts estimate that 10% of new
U.S. cases of blindness result from this disease. Approximately
300,000 people suffer from uveitis in the United States alone , the
majority of whom are affected by anterior uveitis. The only
therapeutic class approved by the FDA for treatment of uveitis is
corticosteroids, which are burdened with multiple side effects, such
as hypertension, hyperglycemia, hypercholesterolemia, and in the
eye, cataract formation and glaucoma.

About Isotechnika Inc.

----------------------

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 III Canadian trial for the treatment of moderate to severe
psoriasis. ISA247 is currently being investigated in a combined
Phase III European/Canadian psoriasis trial and a Phase IIb 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 I 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 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.

ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., +1-(780)-909-5042, +1-(780)-484-4105,
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1-(780)-909-4661,
+1-(780)-484-4105 (fax), sgillis-paulgaard@isotechnika.com; Lux
Biosciences, Inc. Contact Information: Ulrich Grau, Ph.D.,
+1-(201)-946-0221, ulrich.grau@luxbio.com; Kureczka/Martin Associates
(media), Joan Kureczka, +1-(415)-821-2413 jkureczka@comcast.net


	hier anmelden...