Partnerships
Lux Biosciences
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux Biosciences, Inc. (Lux) of Jersey City, New Jersey granting Lux worldwide rights to develop and commercialize Isotechnika’s lead drug, voclosporin, referred to as LX211 by Lux, for the treatment and prophylaxis of all ophthalmic diseases.
Lux received permission from the regulatory agencies in the United States, Canada, the United Kingdom, Germany, France, Austria and India to proceed with three separate Phase 2/Phase 3 clinical trials investigating voclosporin for the treatment of active and control of quiescent non-infectious uveitis. Uveitis refers to immune mediated, chronic inflammation or swelling of the eye's structures. Patient treatment in these trials commenced in February 2007. Lux expects to complete enrollment in the summer of 2008.
Official notification from the European Medicines Agency granting orphan medicinal product designation for voclosporin for the treatment of chronic, non-infectious uveitis was received on September 14, 2007. This designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, fee reductions and free scientific advice. Previously in January 2007, Lux was granted orphan drug status for voclosporin for non-infectious, intermediate and pan uveitis from the FDA in the United States.
Lux recieved "Fast-Track" designation from the FDA for voclosporin for the treatment of uveitis in August 2007. "Fast-track" designation will provide various means to expedite the development and review of voclosporin. The process could be facilitated through meetings and other correspondence with the FDA reviewers, consideration for priority review, and the ability to submit portions of a New Drug Application (NDA) early for review as part of a "rolling" submission.
Lux initiated pivotal trials of voclosporin in uveitis in February, 2007. The pivotal trial program, which consists of three controlled, double masked studies, is investigating the use of voclosporin in different forms of active uveitis in addition to maintenance of quiescent disease. Results from the LUMINATE trial are expected in the first half of 2009. Lux also expects to submit an NDA in the first half of 2009.
Dry eye syndrome is the second ophthalmic indication that Lux intends to investigate. It is one of the most common conditions treated by eye physicians and is usually caused by a problem with the quality and quantity of the tear film that lubricates the eyes resulting from chronic inflammation of the tear-producing lacrimal gland. Lux expects to commence clinical trials with LX214, a proprietary mixed micellar topical formulation of voclosporin for dry eye syndrome in the second half of 2008>