Form 8-K

0001193125-12-015727.txt : 20120118 0001193125-12-015727.hdr.sgml : 20120118 20120118173006 ACCESSION NUMBER: 0001193125-12-015727 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20120117 ITEM INFORMATION: Other Events FILED AS OF DATE: 20120118 DATE AS OF CHANGE: 20120118 FILER: COMPANY DATA: COMPANY CONFORMED NAME: XENOPORT INC CENTRAL INDEX KEY: 0001130591 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943330837 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51329 FILM NUMBER: 12532898 BUSINESS ADDRESS: STREET 1: 3410 CENTRAL EXPRESSWAY CITY: SANTA CLARA STATE: CA ZIP: 95051 BUSINESS PHONE: 4086167200 MAIL ADDRESS: STREET 1: 3410 CENTRAL EXPRESSWAY CITY: SANTA CLARA STATE: CA ZIP: 95051 8-K 1 d284855d8k.htm FORM 8-K Form 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 17, 2012

XENOPORT, INC.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)


000-51329		94-3330837
(Commission File No.)		(IRS Employer Identification No.)

3410 Central Expressway

Santa Clara, California 95051

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (408) 616-7200

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Section 8 – Other Events.

Item 8.01

Other Events.

On January 17, 2012, XenoPort, Inc. (“XenoPort” or the “Company”) and Astellas Pharma Inc. (“Astellas”) announced that Regnite^® (gabapentin enacarbil) has received marketing approval in Japan for the treatment of moderate-to-severe primary restless legs syndrome (“RLS”).

The New Drug Application filing for Regnite employed a bridging strategy based on data supporting safety and efficacy from the successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan, as well as the RLS clinical program conducted by XenoPort in the United States and supporting pharmacokinetic studies conducted by XenoPort in Japanese subjects. Each of the efficacy studies showed that treatment with Regnite was associated with improvement in the International Restless Legs Syndrome rating scale score compared to placebo. Improvement over placebo was also observed on the investigator-rated clinical global impression of improvement scale. The most commonly reported adverse events for Regnite were somnolence and dizziness, which were generally transient and mild to moderate in severity.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


		XENO PORT, INC.
		(Registrant)

Dated: January 18, 2012	By:	/s/ William G. Harris
		William G. Harris
		Senior Vice President of Finance and Chief Financial Officer