Neurology Pipeline

Valeant's Neurology pipeline includes the late stage development compound, ezogabine/retigabine, a neuronal potassium channel opener for the adjunctive treatment of partial-onset seizures in adult patients with refractory epilepsy. Known as Potiga™ in the U.S. and Trobalt™ outside the U.S., we believe Potiga™ / Trobalt™ could offer an important adjunctive treatment option for partial onset seizures that are not well-controlled. In August 2010, Valeant, along with our partner, GlaxoSmithKline (GSK) announced that the U.S. Food and Drug Administration (FDA) advisory committee voted unanimously that clinical studies had provided substantial evidence of the effectiveness of Potiga™ as an adjunctive treatment for adults with partial-onset seizures. In April 2011, Valeant and GSK submitted a response to a Complete Response letter they received from the FDA for Potiga™ in November 2010. A Complete Response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of a file is completed and questions remain that preclude the approval of the NDA in its current form.

In January 2011, Valeant and GSK were notified that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion, recommending authorization for Trobalt™ as an adjunctive treatment of partial onset seizures and we received final marketing authorization in March 2011. In addition, Trobalt™ received preliminary approval from the Swiss Agency for Therapeutic products, Swissmedic, in December 2010. Valeant is hopeful that its partner, GSK, will be in a position to launch Trobalt™ in Europe shortly.