Item 8.01 Other Events.
On November 19, 2009, XenoPort, Inc. and Astellas Pharma Inc. announced that a
new drug application ("NDA") has been filed with the Pharmaceuticals and Medical
Device Agency in Japan for XP13512/ASP8825 (gabapentin enacarbil) as a potential
treatment for restless legs syndrome ("RLS"). The data supporting safety and
efficacy in the NDA filing comes from the successful Phase 2 study in RLS
patients and long-term safety study conducted by Astellas in Japan and the RLS
clinical program conducted by XenoPort in the United States. The acceptance of
filing of the NDA triggers a $5 million milestone payment from Astellas to
XenoPort.
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