Lux Biosciences, Inc.

LUVENIQ™

LUVENIQ™ (LX211) is the oral form of a next-generation calcineurin inhibitor, voclosporin. Like other molecules of this class, the compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release.

LUVENIQ (oral voclosporin) was discovered by Isotechnika, Inc. in Edmonton, Alberta, Canada (now at Isotechnika Pharma Inc.) based on unique insights into the in vivo metabolism of calcineurin inhibitors. LUVENIQ is highly potent in various animal models of autoimmune diseases, including experimental uveitis. LUVENIQ is differentiated from the first-generation calcineurin inhibitors by its molecular structure and binding to its biologic target calcineurin phosphatase, and by its metabolic pathway and the associated pharmacokinetic and pharmacodynamic features, which may be linked to advantages in safety.

In early 2010, Lux Biosciences simultaneously submitted a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for LUVENIQ for noninfectious uveitis affecting the intermediate and posterior segments of the eye to the Food and Drug Administration (FDA) and to the European Medicines Agency (EMA), respectively. The review of the MAA by EMA is ongoing. 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. This new trial will be similar in design to the LX211-01 study, but will include key design improvements.

Lux Biosciences has exclusive worldwide rights to develop and commercialize voclosporin for ophthalmic use under its license with Paladin Labs Inc.