LUX RECEIVES ORPHAN DRUG DESIGNATION FOR TWO EYE PRODUCTS

The FDA has granted orphan drug designation to two of Lux Biosciences' investigational therapeutics, the company announced. The first, LX211, is a next-generation calcineurin inhibitor intended for the treatment of noninfectious uveitis. The second, LX201, is a cyclosporine A-eluting silicone matrix ocular implant for the prevention of rejection in corneal transplantation.

Orphan drug designation is a special status for diseases or conditions affecting fewer than 200,000 patients in the United States, according to Lux. Orphan drug designation qualifies the sponsor for exclusive U.S. marketing rights for seven years if the company is first to receive marketing approval. The designation also positions Lux Biosciences to benefit from certain tax credits and waives the company's obligation to pay FDA application user fees for these products.

"Both LX211 and LX201 have the potential of establishing new treatment paradigms in these two indications of high medical need," Ulrich Grau, president and CEO of Lux Biosciences, said. "The only drugs currently approved in uveitis are steroids, and no drug has been approved to prevent rejection in corneal transplantation."

Lux plans to begin enrolling patients in pivotal clinical trials for LX211 this month. The company is currently conducting three controlled, double-blind studies aimed at supporting the approval of that product as a treatment for uveitis, an autoimmune disease characterized by chronic inflammation of the eye. The company also expects to initiate pivotal trials of LX201 in the corneal transplant setting in the first quarter of 2007.