0001564590-17-005755.txt : 20170331 0001564590-17-005755.hdr.sgml : 20170331 20170331132303 ACCESSION NUMBER: 0001564590-17-005755 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170331 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170331 DATE AS OF CHANGE: 20170331 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: 17729400 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 acor-8k_20170331.htm 8-K acor-8k_20170331.htm

 

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):  March 31, 2017

 

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 8.01Other Events

 

On March 31, 2017, Acorda Therapeutics, Inc. (the “Company”) announced that the United States District Court for the District of Delaware upheld U.S. Patent No. 5,540,938 (the ‘938 patent), which pertains to the formulation of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg and is set to expire in July 2018. The Court invalidated U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,007,826 (the ‘826 patent), 8,440,703 (the ‘703 patent), and 8,354,437 (the ‘437 patent) which pertain to AMPYRA. The Company will appeal the ruling on these patents. The Company has developed contingency plans to address its business needs and objectives in the event of a loss of AMPYRA exclusivity, and will provide an update after finalizing the implementation timeline. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item.

 

Item 9.01Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.

 

Description

 

99.1

Press Release dated March 31, 2017



 

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.

 

 

 

March 31, 2017

By:

/s/ David Lawrence

 

 

Name: David Lawrence

 

 

Title: Chief, Business Operations and Principal Accounting Officer

 

 



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

99.1

Press Release dated March 31, 2017

 

 

EX-99.1 2 acor-ex991_36.htm EX-99.1 acor-ex991_36.htm

EXHIBIT 99.1

CONTACT:

 

Felicia Vonella

Acorda Therapeutics

fvonella@acorda.com

(917) 826-3427

 

 

FOR IMMEDIATE RELEASE

 

U.S. District Court Issues Decision to Invalidate Four AMPYRA Patents; Company Will Appeal Ruling

 

 

ARDSLEY, N.Y. – March 31, 2017 – Acorda Therapeutics, Inc. (Nasdaq: ACOR ) today announced that the United States District Court for the District of Delaware upheld U.S. Patent No. 5,540,938 (the ‘938 patent), which pertains to the formulation of AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg and is set to expire in July 2018. The Court invalidated U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,007,826 (the ‘826 patent), 8,440,703 (the ‘703 patent), and 8,354,437 (the ‘437 patent) which pertain to AMPYRA. The Company will appeal the ruling on these patents.

 

“We are disappointed by the Court’s decision and are preparing our appeal,” said Ron Cohen, M.D., Acorda's President and CEO, “Medical innovation depends on the recognition of valid intellectual property claims. We believe that we demonstrated novel and unexpected findings in our AMPYRA development program that led to the issuance of valid patents.”

 

The Company has developed contingency plans to address its business needs and objectives in the event of a loss of AMPYRA exclusivity, and will provide an update after finalizing the implementation timeline.

 

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders.

 

Acorda has an industry leading pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease, migraine and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

 

For more information, please visit the Company’s website at: www.acorda.com.

 

 


Forward-Looking Statement

 

These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations and Civitas’ operations, respectively, into our operations; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the court decision in our litigation against filers of Abbreviated New Drug Applications (each, an “ANDA”) to market generic versions of Ampyra in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301 or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, any other products under development, or the products that we will acquire when we complete the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.​

 

###

 

 

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