Valeant, GSK Enter Retigabine Pact

Valeant Pharmaceuticals and GlaxoSmithKline have entered into an exclusive worldwide collaboration for the investigational drug retigabine, a neuronal potassium channel opener for treatment of adult epilepsy patients with refractory partial onset seizures. Retigabine has shown efficacy and safety in two Phase III trials in patients with refractory epilepsy receiving treatment with as many as three antiepileptic drugs (AEDs). The two companies plan to file a NDA in the U.S. and a MAA in Europe by early 2009. The drug is also being studied in patients with post-herpetic neuralgia (PHN), a painful and common complication of shingles.
   
Under the terms of the agreement, Valeant will grant GSK worldwide development and commercialization rights to retigabine, VRX698 and the other compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million. Valeant is eligible to receive as much as $545 million based on certain regulatory, development and commercialization milestones, as well as the development of additional indications for retigabine. Valeant will co-commercialize and share as much as half of the profits in the U.S., Canada, Australia, New Zealand and PR, and will receive as much as a 20% royalty on sales outside those regions. The two companies will share global R&D expenses for retigabine, and GSK will fund the development of VRX698 and the other back-up compounds from the program. Valeant could receive an additional $150 million based on the achievement of certain milestones for VRX698 and the back-up compounds, and double-digit royalties on worldwide sales.
   
“We were pleased with the significant interest shown in retigabine and we have selected GSK as a collaborator because we believe they are ideally suited and strongly committed to the continued development of this important compound,” stated J. Michael Pearson, chairman and chief executive officer of Valeant. “GSK’s development expertise and strong commercial infrastructure will be critical to maximizing the worldwide potential of retigabine. We believe this collaboration will strengthen our ability to bring this medicine to patients suffering from epilepsy and a variety of other conditions.”
   
“GSK is looking forward to working with Valeant to provide important medicines like retigabine to the medical community and to the patients we serve,” commented Steve Stefano, senior vice president, GSK U.S. NeuroHealth Division. “There is a significant need for novel anti-epileptic drugs, as almost one-third of patients with epilepsy continue to experience seizures despite treatment with currently available medications. We believe that retigabine could potentially play a significant role in improving the management of epilepsy and is a welcome addition to GSK’s portfolio.”