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EMEA
Committee for Orphan Medicinal Products Recommends Orphan Medicinal
Product Designation for
Lux
Biosciences’ |
|
|
JERSEY CITY,
N.J. (July 31, 2007)
--
Lux Biosciences, Inc., a privately held biotechnology
company specialized in the field of ophthalmic diseases, announced today
that the EMEA committee 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 BiosciencesLux 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:
For more information on Lux Biosciences, please visit the company’s website at www.luxbio.com. ### CONTACTS:
Lux Biosciences,
Inc.
Linnden Communications
(media)
© 2008 Lux Biosciences, Inc. All rights reserved. Web Terms
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