Healthcare Industry News:  calcineurin inhibitor 

Biopharmaceuticals Ophthalmology FDA

 News Release - January 15, 2007

Lux Biosciences Receives Orphan Drug Designation from the FDA for Two Ophthalmic Products

LX211 for the treatment of uveitis
LX201 for the prevention of corneal transplant rejection

JERSEY CITY, N.J., Jan. 15 (HSMN NewsFeed) -- Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to two of the company's investigational therapeutics. The first, LX211, is a next-generation calcineurin inhibitor intended for the treatment of noninfectious posterior, intermediate and panuveitis. The second, LX201, is a cyclosporine A (CsA)-eluting silicone matrix ocular implant for the prevention of rejection in corneal transplantation.

Orphan drug designation is a special status for diseases or conditions affecting fewer than 200,000 patients in the United States, granted by FDA upon request by a sponsor. Orphan drug designation qualifies the sponsor for exclusive U.S. marketing rights 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 these two late-stage products in our pipeline," said Ulrich Grau, president and chief executive officer of Lux Biosciences. "Both LX211 and LX201 have the potential of establishing new treatment paradigms in these two indications of high medical need. The only drugs currently approved in uveitis are steroids, and no drug has been approved to prevent rejection in corneal transplantation."

Lux Biosciences plans to begin enrolling patients in pivotal clinical trials for LX211 in early January 2007. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, an autoimmune disease characterized by chronic inflammation of the eye. Lux Biosciences also expects to initiate pivotal trials of LX201 in the corneal transplant setting in the first quarter of 2007.

About LX211

LX211 is a next-generation calcineurin inhibitor to which Lux Biosciences has an exclusive worldwide license for ophthalmic indications from Isotechnika, Inc., of Edmonton, Canada (Isotechnika's code ISA247). Isotechnika is currently investigating ISA247 in phase 3 clinical trials in psoriasis patients, and in a phase 2b clinical trial in solid organ transplant recipients. The clinical data gathered to date indicate that LX211 is a potent calcineurin inhibitor -- a biological mechanism demonstrated to provide efficacy in a range of autoimmune diseases such as noninfectious uveitis -- and also appears to be well-tolerated. In addition to uveitis, Lux Biosciences plans to develop this molecule in other ophthalmic indications, including dry eye syndrome and age-related macular degeneration.

About LX201

LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for one year. Cyclosporine A is used widely as systemic therapy for the prevention of rejection following kidney and other solid organ transplantation, LX201 is implanted under the eyelid into the subconjunctival space (the area beneath the transparent tissue covering the white of the eye) in a minimally invasive procedure. Lux Biosciences plans to clinically evaluate the implant for the prevention of rejection in corneal transplantation.

Lux Biosciences was previously granted orphan drug status for LX201 in Europe.

About Lux Biosciences

Lux Biosciences is a privately held biotechnology company dedicated to the identification, optimization, development and commercialization of products for the treatment of ophthalmic diseases. The company's business strategy is characterized by:
* A focus on compounds already marketed or with clinical proof-of-concept
in non-ophthalmic indications that Lux Biosciences will develop as
unique, targeted therapies for corresponding ophthalmic diseases, with
potentially greater efficacy and safety than existing treatments.

* A clinical-stage portfolio of projects including: i) a next-generation
calcineurin inhibitor that has potential in several ophthalmic diseases
and, as such, represents a pipeline of product opportunities; and ii) a
silicone matrix ocular implant that steadily releases therapeutic doses
of cyclosporine A locally to the eye. Pivotal clinical studies of Lux
Biosciences's most advanced products, LX211 for the treatment of
uveitis and LX201 for the prevention of corneal transplant rejection,
are expected to initiate in Q1 2007.

* A proprietary product-enabling bio-erodable polymer technology that
potentially allows targeted and controlled delivery of Lux Biosciences
molecules to the eye and that has achieved FDA regulatory validation as
a device for another indication.

For more information on Lux Biosciences, please visit the company's website at

Source: Lux Biosciences

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