Under the terms of the agreement, Valeant will grant GlaxoSmithKline (GSK) worldwide development and commercialization rights to retigabine, VRX698 and the other back-up compounds from the potassium channel opener discovery program in exchange for an upfront payment of $125 million to Valeant.
Additionally, GSK will pay Valeant up to $545 million based on the achievement of certain regulatory, development and commercialization milestones and the development of additional indications for retigabine.
Valeant will co-commercialize with GSK and will share up to 50% of net profits within the US, Canada, Australia, New Zealand and Puerto Rico, and will receive up to a 20% royalty on net sales of retigabine outside those regions.
The two companies will jointly fund all global R&D expenses for retigabine, and GSK will completely fund the development of VRX698 and the other back-up compounds from the potassium channel opener discovery program. Valeant could receive up to an additional $150 million based on the achievement of certain regulatory, development and commercial milestones for VRX698 and the back-up compounds and double-digit royalties on worldwide sales.
Valeant and GSK plan to file a new drug application in the US and a marketing authorization application in Europe by early 2009. The retigabine program also includes an ongoing study in patients with post-herpetic neuralgia, a painful and common complication of shingles.