Healthcare Industry News:  Uveitis 

Devices Licensing Ophthalmology

 News Release - November 7, 2006

Lux Biosciences Announces Exclusive Worldwide License Agreement with NIH for Late Stage Ophthalmic Product

LX201 is the Second Pivotal Stage Program in the Lux Biosciences Pipeline and Will Be Evaluated for Prevention of Rejection Following Corneal Transplantation

JERSEY CITY, N.J., Nov. 7 (HSMN NewsFeed) -- Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today the inclusion of a second pivotal stage project into its development pipeline, having entered into an exclusive world-wide license agreement with the National Institutes of Health (NIH) to acquire rights to intellectual property covering a cyclosporine A (CsA) eluting silicone matrix ocular implant, renamed LX201, based on work conducted at the National Eye Institute (NEI). In addition, the Commission of Orphan Medicinal Products (COMP) has recommended that LX201 receive European orphan drug designation for LX201. Following protocol approval by the U.S. Food and Drug Administration, the Company expects to initiate pivotal trials in early 2007, with an estimated New Drug Application (NDA) submission scheduled for early 2009. Financial terms of the agreement were not disclosed.

"This agreement is another significant milestone for Lux in our first year of operations. We now have two late-stage clinical compounds in our development pipeline LX201 and LX211, a next generation calcineurin inhibitor for the treatment of Uveitis, with both compounds targeted to meet significant unmet medical needs," said Ulrich Grau, Ph.D., President and Chief Executive Officer of Lux Biosciences. "We believe that LX201 will establish a new treatment paradigm for patients receiving cornea transplants and who are at increased immunological risk for rejection and graft loss."

LX201 is a silicone matrix ocular implant that steadily releases therapeutic doses of cyclosporine A locally to the eye over the course of at least 1 year. Cyclosporine A is used widely as systemic therapy (oral capsule) for the prevention of rejection following solid organ transplantation, such as kidney transplants, and it is also indicated for the treatment of various autoimmune conditions, such as rheumatoid arthritis. LX201 is implanted under the eyelid into the subconjuctiva (the area beneath the transparent membrane covering the white of the eye) in a minimally invasive procedure. The implant will be clinically evaluated for the prevention of rejection in corneal transplantation.

Local delivery of CsA through LX201 offers potentially significant benefits in the treatment of corneal transplantation due to: (i) increased safety resulting from the absence of systemic toxicity of CsA, in particular of renal toxicity, as LX201 (ocular implant) does not produce measurable systemic levels; (ii) increased efficacy as LX201 can establish continuous and relatively high therapeutic levels of CsA -- higher than could be established by tolerable oral doses -- at or near the transplanted cornea; and (iii) increased patient compliance as the implant is hardly perceptible by the patient and doses cannot be missed throughout the first year after transplantation.

About Corneal Transplantation

The cornea is one of the most frequently transplanted organs, in fact, according to the Eye Bank of America approximately 32,000 corneas are transplanted each year in the United States and some 22,000 in Europe. While the cornea is generally a tissue that is not vascularized -- does not contain blood vessels -- and is less prone to acute rejection, there are a substantial number of patients that are at increased risk of immune rejection. This group of patients is most likely to benefit from LX201, in particular those receiving a re- transplant after an earlier graft loss or those who previously have had a rejection episode.

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 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 a next-generation calcineurin inhibitor that has potential in several ophthalmic diseases and, as such, represents a pipeline of product opportunities. The initial one of these is planned to enter pivotal clinical testing by early 2007, and -- if successful -- Lux expects it will reach the market in 2009

-- A proprietary product enabling bio-erodable polymer technology that allows targeted delivery of Lux molecules to the eye

This strategy is being implemented by an experienced, execution-oriented management team that combines a history of achievement in drug development and commercialization with deep insight and scientific expertise in immunology and ophthalmology. More information on Lux Biosciences can be found at www.luxbio.com.


Source: Lux Biosciences

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