Healthcare Industry News:  Age-related Macular Degeneration 

Biopharmaceuticals Ophthalmology Regulatory

 News Release - July 31, 2007

EMEA Committee for Orphan Medicinal Products Recommends Orphan Medicinal Product Designation for Lux Biosciences' LX211 for the Treatment of Uveitis

JERSEY CITY, N.J.--(HSMN NewsFeed)--Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that the EMEA committee for Orphan Medicinal Products has adopted a positive opinion on orphan medicinal product designation for the company's investigational therapeutic, LX211, for the treatment of chronic, non-infectious uveitis. LX211 is a next-generation calcineurin inhibitor intended for the treatment of non-infectious posterior, intermediate and panuveitis (an autoimmune disease characterized by chronic inflammation of the eye).

The EMEA will now forward the opinion to the European Commission. The Decision will be adopted by the Commission, within 30 days of its receipt of the opinion.

Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, fee reductions and free Scientific Advice.

Lux Biosciences began enrolling patients in pivotal clinical trials for LX211 earlier this year. The company is conducting three controlled, double-masked studies aimed at supporting the approval of that product as a treatment for uveitis, collectively designated the LUMINATE program. The LUMINATE program represents the largest and most comprehensive clinical program ever undertaken in the field of uveitis

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. Lux Biosciences was previously granted orphan drug status for LX211 by the FDA in USA.

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) LX211, a next-generation calcineurin inhibitor that has potential in several ophthalmic diseases and, as such, represents a pipeline of product opportunities; and ii) LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye. Both the LUMINATE pivotal clinical program for LX211 for the treatment of uveitis, as well as the LUCIDA pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007.
  • Proprietary product-enabling bio-erodible polymer technologies that facilitate targeted and sustained delivery of molecules to the eye.
For more information on Lux Biosciences, please visit the company's website at www.luxbio.com.


Source: Lux Biosciences

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