-----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, THDGv47bUTHiwDRrSneCS2eh/NNkedv0mpdwJN1jLPgVUz+4anzvpxbPBDZlQ0eR nbRtfffPLwO0PtXKjZLG3A== 0001104659-06-080276.txt : 20061208 0001104659-06-080276.hdr.sgml : 20061208 20061208060918 ACCESSION NUMBER: 0001104659-06-080276 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061207 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061208 DATE AS OF CHANGE: 20061208 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 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50513 FILM NUMBER: 061264133 BUSINESS ADDRESS: STREET 1: 15 SKYLINE DRIVE CITY: HAWTHORNE STATE: NY ZIP: 10532 BUSINESS PHONE: 914-347-4300 8-K 1 a06-24093_58k.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):  December 7, 2006

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 December 8, 2006, Acorda Therapeutics, Inc. (“Acorda”) issued a press release providing an update on its clinical development of Fampridine-SR pursuant to a meeting with the U.S. Food and Drug Administration.

A copy of the press release is attached hereto as Exhibit 99.1 and incorporated by reference into this Item.

Item 9.01 Financial Statements and Exhibits

99.1         Press Release dated December 8, 2006

2




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.

 

 

 

 

 

 

 

 

 

 

 

 

December 8, 2006

By:

/s/ David Lawrence

 

 

 

 

Name: David Lawrence

 

 

 

 

Title: Chief Financial Officer

 

 

 

 

3




Exhibit Index

Exhibit No.

 

Description

 

 

 

 

99.1

 

Press Release dated December 8, 2006

 

4



EX-99.1 2 a06-24093_5ex99d1.htm EX-99

Exhibit 99.1

CONTACTS:

 

Tierney Saccavino

Acorda Therapeutics

(914) 347-4300 ext. 104

tsaccavino@acorda.com

 

FOR IMMEDIATE RELEASE

 

Acorda Therapeutics Provides Update on Clinical Development of Fampridine-SR

 

HAWTHORNE, NY, December 8, 2006 – Acorda Therapeutics, Inc.® (Nasdaq: ACOR) today confirmed that, based on feedback it received in a meeting with the U.S. Food and Drug Administration (FDA), it will design and conduct an additional Phase 3 trial of Fampridine-SR in people with MS. Consistent with that meeting, the company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the Timed 25 Foot Walk.

 

In September 2006, the Company announced the results of its recent Phase 3 study, MS-F203, which was based on a Special Protocol Assessment (SPA) from the FDA. The FDA indicated that, while this would require confirmation in a New Drug Application (NDA) filing, the criteria for the SPA appear to have been met. Typically, the FDA requires two adequate and well-controlled studies, each convincing on its own, to establish substantial evidence of effectiveness.

 

Based on the discussion, Acorda also plans to execute a QT study in accordance with the FDA’s October 2005 guidance, “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs”. The Company will continue to consult with the FDA on protocol development for both of these studies and any additional requirements that might be needed.

 

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsulesä (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda’s lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study 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, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. 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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