Orphan drug designation is a special status for diseases or conditions affecting fewer than 200,000 patients in the US.
“Both LX211 and LX201 have the potential of establishing new treatment paradigms in these two indications of high medical need. The only drugs currently approved in uveitis are steroids, and no drug has been approved to prevent rejection in corneal transplantation,” said Ulrich Grau, president and CEO of Lux Biosciences.
Orphan drug designation qualifies the sponsor for exclusive US marketing rights for seven years. The designation also positions Lux Biosciences to benefit from certain tax credits and waives the company's obligation to pay user fees for these products.
Lux Biosciences plans to begin enrolling patients in trials for LX211 in early January 2007. The company is conducting three studies aimed at supporting the approval of that product as a treatment for uveitis, an autoimmune disease characterized by chronic inflammation of the eye. Lux Biosciences also expects to initiate trials of LX201 in the corneal transplant setting in the first quarter of 2007.