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Re: biomaven0 post# 130192

Friday, 12/02/2011 7:46:12 PM

Friday, December 02, 2011 7:46:12 PM

Post# of 257262
XNPT - Horizant gets Japan approval recommendation

http://biz.yahoo.com/e/111202/xnpt8-k.html

Form 8-K for XENOPORT INC


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2-Dec-2011

Other Events



Item 8.01 Other Events.
XenoPort, Inc. ("XenoPort" or the "Company") has received confirmation from its partner, Astellas Pharma Inc., that, following a meeting on December 2, 2011 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 Restless Legs Syndrome. The MHLW will issue a final notification to Astellas regarding its decision, which the Company expects to occur in the first quarter of 2012.

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