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Lux Biosciences Receives Acceptance of Luveniq™ MAA Filing from European Medicines Agency

JERSEY CITY, N.J., March 2, 2010 -- Lux Biosciences, Inc. today announced that the European Medicines Agency (EMA) has accepted the filing of the company’s Marketing Authorization Application (MAA) for the company’s lead product, Luveniq™ (LX211; oral voclosporin) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye. Lux previously announced the filing of both the MAA and U.S. New Drug Application (NDA) for LX211, which has received Orphan Drug designation in both regions, on February 4, 2010.

“We are very pleased that our European marketing application for LX211 has been formally accepted for review,” said Eddy Anglade, M.D., Lux Biosciences’ Chief Medical Officer. “We now look forward to hearing from the U.S. Food and Drug Administration on our NDA filing, for which we have also requested priority review.”

The US FDA has up to 60 days to formally accept the completed application. Upon acceptance, the FDA will determine if the application will be granted priority review, which would allow for a six month review of the NDA.

About LUVENIQ™
LUVENIQ (LX211) is the oral form of a next-generation calcineurin inhibitor, voclosporin. Like other molecules of this class, the compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release. Lux Biosciences has exclusive worldwide rights to voclosporin for ophthalmic use and is cooperating with the team at Isotechnika Pharma who discovered the molecule and develop it in psoriasis and organ transplantation.

About Uveitis
Uveitis, which represents a group of serious inflammatory eye conditions, is inevitably associated with either severe vision loss or substantial morbidity from steroid use. Non-infectious uveitis involving the posterior segment of the eye is a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world. As the majority of uveitis patients are first diagnosed at ages under 40 years, the socio-economic burden of this disease is higher than that of other serious ocular conditions such as AMD and diabetic macular edema.

About Lux Biosciences
Lux Biosciences, Inc. is a privately held biotechnology company focused on the treatment of ophthalmic diseases. Its submission stage project LUVENIQ (LX211) is the oral formulation of a next-generation calcineurin inhibitor (voclosporin) for which positive phase 3 data have been obtained for the treatment of sight-threatening non-infectious uveitis. The company has several earlier stage projects based on its mixed nanomicellar ocular formulation technology, and based on its 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.

Lux Biosciences cautionary statement regarding forward-looking statements
This press release may contain forward-looking statements, including Lux Bioscience's belief as to the medical and commercial potential of its product candidates, Lux Bioscience's plans to pursue business and regulatory strategy, and Lux Bioscience’s expectations regarding actions and decisions solely within the control and purview of other parties. These forward-looking statements involve important known and unknown risks and uncertainties, which could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the exercise of discretion by regulatory agencies and other parties, the availability to Lux Biosciences of funds and resources to pursue research and development projects, the performance of activities and generation of scientific data by parties other than Lux Biosciences, the ability of Lux Biosciences to economically manufacture and commercialize its products once approved, acceptance by the medical community of Lux Biosciences’ products once approved and the availability of alternative therapeutic agents, approval for reimbursement by third-party payors of Lux Biosciences’ products once approved, the success and timely completion of clinical trials and other scientific studies, the ability of Lux Biosciences and its licensors to defend its and their patents from infringement by third parties, and the risk that such patents may be subsequently shown to be invalid or that the practice of such patents may infringe the patents of others. Further, Lux Biosciences disclaims any undertaking to issue further press releases or otherwise advice about changes to these beliefs, plans and expectations.

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CONTACT:
Joan Kureczka
+1 415 821 2413
+1 415 690 0210 Mobile
Kureczka/Martin Associates
Jkureczka@comcast.net

 

   
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