Valeant Readies RESTORE2 Trial

Valeant Pharmaceuticals has reached full enrollment in RESTORE2, its second Phase III study of retigabine in the treatment of epilepsy. Retigabine is a first-in-class neuronal potassium channel opener demonstrated to be effective in a recently published Phase IIb epilepsy study. The two RESTORE trials (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) are designed to evaluate the efficacy and safety of retigabine as an adjunctive therapy in patients with refractory partial-onset seizures who are receiving one, two or three concomitant antiepileptic drugs (AEDs). RESTORE2 is investigating retigabine at 600 and 900 milligrams per day while RESTORE1 is investigating retigabine at 1,200 milligrams per day.

“More than 50 million people worldwide have epilepsy and the global market for AEDs is more than $13 billion and growing,” said Timothy C. Tyson, Valeant’s president and chief executive officer. “The development of retigabine, which will be the first and only potassium channel opener for the treatment of refractory epilepsy, is our highest R&D priority at Valeant. We are pleased to be leading the way in the research and development of potassium channel openers for the treatment of important neurological disorders such as epilepsy and neuropathic pain.”

Five hundred and thirty-nine patients have enrolled in RESTORE2, which is being conducted in 69 sites across Europe, Israel, Australia, South Africa and the United States. The RESTORE1 trial is being conducted in 49 sites across the United States, Argentina, Mexico, Brazil and Canada. To date, more than 85% of eligible patients involved in RESTORE trials have chosen to enter into ongoing open-label extension studies.

Following the anticipated completion of the RESTORE trials in 2Q08, Valeant plans to file an NDA and MAA for retigabine, with an anticipated launch in 2009.