Lux Biosciences, Inc.

HISTORY

Lux Biosciences was founded in 2006 with a series A financing and the in-licensing of worldwide exclusive rights in all ophthalmic indications to intellectual property covering voclosporin--including LUVENIQ™ (LX211/voclosporin capsule) — from Isotechnika, Inc. (In 2009, Paladin Labs Inc. became the owner of these intellectual property rights. Lux’s rights were not affected by that transfer, and Lux continues to work closely with Paladin Labs and with the team that discovered voclosporin, who are now at Isotechnika Pharma Inc. and who continue to develop voclosporin in indications outside of ophthalmology). Based on regulatory interactions with the United States Food and Drug Administration (FDA) and European health authorities, the company was able to progress its development programs for LUVENIQ into Phase 3 clinical trials at the beginning of 2007. In early 2010, Lux Biosciences simultaneously submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for LUVENIQ for noninfectious uveitis to the FDA and to the European Medicines Agency (EMA), respectively. A Complete Response letter regarding the NDA for LUVENIQ was received from FDA in August 2010, in which the FDA requested an additional pivotal trial, which Lux Biosciences is actively planning and is expected to begin before the end of 2010. The review of the MAA by EMA is ongoing.

In addition, through collaboration with the University of Missouri at Kansas City, LX214, a proprietary topical product containing voclosporin for dry eye has been formulated and has completed Phase 1 clinical development. The company has also expanded its portfolio with an exclusive license to a proprietary bio-erodible polymer technology originally invented at Rutgers University. Animal studies for LX212, a bio-erodible ocular polymer implant containing voclosporin have been completed.