-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WpijXDxARDg8Iad1fK5QRS+MXDsIIH76Z5clYtucIflpqwwlVwSl3+hH9saLC613 S1MeuDbftbFRm3HMYelcSw== 0001104659-07-086282.txt : 20071130 0001104659-07-086282.hdr.sgml : 20071130 20071130140759 ACCESSION NUMBER: 0001104659-07-086282 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071130 ITEM INFORMATION: Other Events FILED AS OF DATE: 20071130 DATE AS OF CHANGE: 20071130 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACORDA THERAPEUTICS INC CENTRAL INDEX KEY: 0001008848 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50513 FILM NUMBER: 071277375 BUSINESS ADDRESS: STREET 1: 15 SKYLINE DRIVE CITY: HAWTHORNE STATE: NY ZIP: 10532 BUSINESS PHONE: 914-347-4300 8-K 1 a07-30294_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

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):  November 30, 2007

 

Acorda Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

000-50513

13-3831168

(State or other jurisdiction

(Commission

(I.R.S. Employer

of incorporation)

File Number)

Identification No.)

 

15 Skyline Drive, Hawthorne, NY

10532

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code:  (914) 347-4300

 

Not Applicable

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:

 

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

 

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

 

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

 

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

 

 



 

 Item 8.01 Other Events.

 

On November 30, 2007, Acorda Therapeutics, Inc. issued a press release announcing the completion of enrollment for its MS-F204 Phase 3 clinical study of Fampridine-SR in multiple sclerosis.  A copy of the release is attached hereto as Exhibit 99.1 and incorporated by reference into this Item.

The information in this Item 8.01 of Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

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.

 

 

 

 

Acorda Therapeutics, Inc.

 

 

 

 

 

 

 

 

 

 

 

November 30, 2007

 

By:

/s/ David Lawrence

 

 

 

 

 

 

 

 

 

Name: David Lawrence, M.B.A.

 

 

 

 

Title: Chief Financial Officer

 

 

2



 

Exhibit Index

 

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated November 30, 2007

 

3


EX-99.1 2 a07-30294_1ex99d1.htm EX-99.1

 

Exhibit 99.1

 

 

CONTACTS:

Tierney Saccavino

Acorda Therapeutics

(914) 347-4300 ext. 104

tsaccavino@acorda.com

 

 

FOR IMMEDIATE RELEASE

 

Acorda Therapeutics Completes Enrollment of Phase 3 Clinical Trial of Fampridine-SR

 

HAWTHORNE, N.Y, November 30, 2007— Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced today that it has completed enrollment for its Phase 3 clinical trial of Fampridine-SR in multiple sclerosis (MS). The trial is designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. 240 patients were enrolled at 39 clinical trial sites in the United States and Canada. The Company expects data from the trial in the second quarter of 2008.

 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for spinal cord injury, multiple sclerosis and related nervous system disorders.  The Company’s marketed products include Zanaflex Capsules™ (tizanidine hydrochloride), a short-acting drug for the management of spasticity. Acorda’s lead clinical product, Fampridine-SR, is in a Phase 3 clinical trial to evaluate its safety and efficacy in improving walking ability in people with MS. The Company’s pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking.  These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics’ ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, failure to protect its intellectual property or to defend against the intellectual property claims of others, the ability to obtain additional financing to support Acorda Therapeutics’ operations, and unfavorable results from its preclinical programs.  These and other risks are described in greater detail in Acorda Therapeutics’ filings with the Securities and Exchange Commission.  Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

 

 


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