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.
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