Lux Biosciences Announces European Medicines Agency Acceptance
of Its Pediatric Investigation Plan for LUVENIQ™

-- Acceptance of PIP is Pre-Requisite for European Approval --

JERSEY CITY, N.J. (November 26, 2008) – Lux Biosciences today announced that the Pediatric Committee of the European Medicines Agency (EMEA) has issued a positive opinion on Lux’s Pediatric Investigation Plan (PIP) for LUVENIQ™ (oral formulation of voclosporin), the company’s potential first-in-class product in Phase 3 development for sight-threatening non-infectious uveitis. The PIP covers children and young adults between the ages of 2 and 17 years who are affected with uveitis. An accepted PIP is a pre-requisite for European approval of new drugs according to legislation passed in January 2007. The aim of the legislation is to facilitate the development of new medicines for children without subjecting them to unnecessary clinical trials or delaying the authorization of those medicines for use in adults.

“Uveitis is a chronic inflammatory disease of the eye that affects relatively few children compared to adults,” commented Ulrich Grau, Ph.D., Lux Biosciences’ President and Chief Executive Officer. “However, children face an even greater risk of blindness from uveitis than do adults, as the rate and spectrum of sight-threatening complications are significant and persist over time. Physicians today rely on corticosteroids to help control uveitis, but the chronic use of corticosteroids at the doses required to hold the disease in check is burdened with serious side effects, such as bone loss, metabolic disturbances, weight gain, depression and many others. Thus, the need for new steroid-sparing therapies for this disease is as critical for children as it is for adults.”

Lux Biosciences completed patient enrollment in mid-2008 in its LUMINATE (Luveniq Uveitis Multicenter Investigation of a New Approach to TrEatment) pivotal clinical trial program, which is investigating the use of LUVENIQ in adult patients with non-infectious uveitis. Data from the LUMINATE program, which consists of three randomized, placebo-controlled, double-masked studies that together enrolled a total of about 560 patients at 58 sites in 7 countries, are expected in Q1 2009. Pending a positive outcome of the LUMINATE Phase 3 trials and subsequent approval by U.S. and European regulatory agencies, LUVENIQ will provide the first steroid-sparing therapy for uveitis.

About LUVENIQ

LUVENIQ is the oral form of a next-generation calcineurin inhibitor, voclosporin, to which Lux Biosciences has an exclusive worldwide license for ophthalmic indications from Isotechnika, Inc., of Edmonton, Canada. The clinical data gathered to date indicate that this molecule is a potent calcineurin inhibitor (a biological mechanism demonstrated to provide efficacy in prevention of organ graft rejection and in a range of autoimmune diseases) with a wide therapeutic window. In addition to its use in uveitis, Lux Biosciences is developing this next generation calcineurin inhibitor in proprietary topical formulations for other ophthalmic indications, including dry eye syndrome and other chronic inflammatory ocular surface diseases, and in age-related macular degeneration.


About Lux Biosciences

Lux Biosciences, Inc. is a privately held biotechnology company focused on ophthalmic diseases. The company has a staged product portfolio of potentially first-in-class therapies distinguished by their short-term path to commercialization and potential to generate high revenue growth. The portfolio includes:

• Two Phase 3 clinical-stage projects including: i) LUVENIQ™, the oral formulation of a next-generation calcineurin inhibitor (voclosporin) developed as steroid-sparing therapy for the treatment of sight-threatening non-infectious uveitis, and ii) LX201, a silicone matrix ocular (episcleral) implant that steadily releases therapeutic doses of cyclosporine A locally to the eye for the prevention of rejection in corneal transplant recipients. Both the LUMINATE pivotal clinical program for Luveniq™ for the treatment of uveitis, as well as the LUCIDA (Lux Corneal Transplant Implant Development and Advancement of Therapy) pivotal clinical program with LX201 for the prevention of corneal transplant rejection were initiated in early 2007 and include sites in North America, Europe and India. Enrollment in the LUMINATE program was completed in June 2008.

• LX214, a novel topical eye drop formulation currently in IND-enabling studies with a target date for entry into the clinic in early 2009. LX214 is based on Lux’s proprietary next-generation calcineurin inhibitor and is targeted towards other chronic inflammatory diseases of the eye, most notably dry eye syndrome, blepharitis and atopic keratoconjunctivitis.

• Several earlier stage projects based on 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.

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CONTACTS:

Lux Biosciences, Inc.
Ulrich Grau, Ph.D.
+1 201 946 0221
Ulrich.grau@luxbio.com

Kureczka/Martin Associates (media)
Joan Kureczka
+1 415-821-2413
Jkureczka@comcast.net