Backing for Japanese approval of Regnite, Ranmark and Cancidas

5 December 2011

USA-based XenoPort (Nasdaq: XNPT) saw its shares rise 3% to $4.73 on Friday, when the company said it has received confirmation from its partner, Astellas Pharma (TYO: 4503) that, following a meeting that day in Japan, the drug evaluation committee of the Japanese Ministry of Health, Labor and Welfare (MHLW) recommended approval of gabapentin enacarbil, which will be known by the trade name Regnite in Japan, for the treatment of Restless Legs Syndrome.

This positive recommendation will be reviewed by the MHLW prior to its final decision on authorizing the marketing of Regnite in Japan for the treatment of RLS. The MHLW will issue a final notification to Astellas regarding its decision, which the company expects to occur in the first quarter of 2012.

Earlier this year, XenoPort received US Food and Drug Administration approval for the drug, which is sold in the USA as Horizant by its marketing partner GlaxoSmithKline (The Pharma Letter April 7).

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