Isotechnika Inc.

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

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

Weitere Meldungen: Isotechnika Inc.

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