0001008848-16-000116.txt : 20160803 0001008848-16-000116.hdr.sgml : 20160803 20160803073032 ACCESSION NUMBER: 0001008848-16-000116 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20160802 ITEM INFORMATION: Other Events FILED AS OF DATE: 20160803 DATE AS OF CHANGE: 20160803 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: 161802225 BUSINESS ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 BUSINESS PHONE: 914-347-4300 MAIL ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 8-K 1 report-anda-080116.htm 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):  August 2, 2016
 
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.)
 
 
 
 
 
   
420 Saw Mill River Road,
Ardsley, NY
 
10502
   
(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:
 
☐ 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))
 
 

Item 8.01 Other Events
On August 2, 2016, Acorda Therapeutics, Inc. (the "Company") entered into a settlement agreement with Alkem Laboratories Ltd. and Ascend Laboratories, LLC (collectively "Alkem") to resolve pending patent litigation brought by the Company against Alkem involving Ampyra® (dalfampridine) Extended-Release Tablets.  The pending patent litigation was filed by the Company in the U.S. District Court for the District of Delaware in response to Alkem's submission of an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA"), seeking marketing approval for a generic version of Ampyra.  As a result of the settlement agreement, Alkem will be permitted to market a generic version of Ampyra in the United States at a specified date in 2027, or potentially earlier under certain circumstances.  The parties will request that the Court enter a Consent Order, in which it will dismiss the Company's litigation against Alkem referred to above.  Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice, as required by federal law.  The settlement with Alkem does not resolve pending patent litigation brought by the Company against other parties who have submitted ANDAs to the FDA seeking marketing approval for generic versions of Ampyra.  The expiration date for the Company's latest expiring Ampyra patent listed in the FDA's Orange Book is May 2027.

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.
     
August 3, 2016
By:
/s/ Michael Rogers
   
Name: Michael Rogers
   
Title: Chief Financial Officer