Japanese approval for Regnite and Ranmark

Japanese drug major Astellas Pharma (TYO: 4503) and USA-based XenoPort (Nasdaq: XNPT) revealed yesterday that their Regnite (gabapentin enacarbil; previously known as XP13512) has received marketing approval in Japan for the treatment of moderate-to-severe primary restless legs syndrome (RLS).

Astellas holds exclusive rights to develop and commercialize XP13512 in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. Under the terms of the Astellas collaboration agreement, XenoPort received an initial license payment of $25 million in December 2005 and, prior to the latest announcement, has received milestone payments of $23 million so far, and a further $10 million as a result of the Japanese approval. The drug is also licensed to the UK’s GlaxoSmithKline for the US market. GSK uses the trade name Horizant, which was approved by the Food and Drug Administration last spring (The Pharma Letter April 7, 2011).

Ronald Barrett, chief executive of XenoPort, stated, “We are very pleased that Regnite has been approved in Japan. We believe that Regnite can offer treatment benefits to RLS patients whose condition is severe enough to need medical treatment. We thank Astellas for all of its efforts to make Regnite available to RLS patients in Japan.”