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): June 8, 2009
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 June 8, 2009, Acorda Therapeutics, Inc. (the “Registrant”) issued a press release announcing that, in response to its eligibility application to the European Medicines Agency (“EMEA”) for Fampridine-SR, the EMEA has notified the Registrant that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application (“MAA”) via the EMEA’s Centralized Procedure. The Centralized Procedure provides for a single, coordinated review that is conducted by the EMEA on behalf of all European Union (“EU”) member states.
The EMEA also designated Fampridine-SR as a New Active Substance (“NAS”); if approved, compounds designated as an NAS receive a 10-year market exclusivity period in EU member states.
A copy of the release is attached hereto as Exhibit 99.1 and is incorporated by reference into this item.
Item 9.01 Financial Statements and Exhibits
99.1 Press Release dated June 8, 2009
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. |
|
|
|
|
|
|
June 8, 2009 |
By: |
/s/ David Lawrence |
|
|
|
|
|
|
|
Name: David Lawrence |
|
|
|
Title: Chief Financial Officer |
2
Exhibit Index
|
Exhibit No. |
|
Description |
|
|
|
|
|
99.1 |
|
Press Release dated June 8, 2009. |