Deal valued at $945 million covers a late-stage epilepsy drug and other neuronal potassium channel openers.
Valeant Pharmaceuticals granted GlaxoSmithKline (GSK) rights to its pipeline of neuronal potassium channel openers, which includes a Phase III compound for epilepsy, for $125 million upfront. Valeant could earn up to $820 million upon achieving certain milestones as well as royalties and profits from sales.
The exclusive, worldwide agreement covers epilepsy drug candidate retigabine, VRX698, and the other back-up compounds. Retigabine is reportedly the first potassium channel opener to reach late-stage clinical development. Valeant and GSK plan to file an NDA and an MAA by early 2009.
GSK will pay up to $545 million based on regulatory, development, and commercialization milestones and the development of additional indications for retigabine. Valeant will co-commercialize the drug, sharing up to 50% of net profits within the U.S., Canada, Australia, New Zealand, and Puerto Rico. The firm will receive up to a 20% royalty on net sales outside these areas. The two companies will jointly cover global R&D expenses for retigabine.
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 $150 million in milestones related to regulatory, development, and commercial successes for all of these compounds. GSK will pay double-digit royalties on worldwide sales.
Retigabine has shown efficacy and safety in two completed Phase III trials conducted in patients with refractory epilepsy receiving treatment with up to three antiepileptic drugs. Retigabine is also in a Phase I trial involving patients with post-herpetic neuralgia, a painful and common complication of shingles.