0001564590-17-003863.txt : 20170309 0001564590-17-003863.hdr.sgml : 20170309 20170309163040 ACCESSION NUMBER: 0001564590-17-003863 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170309 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170309 DATE AS OF CHANGE: 20170309 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: 17678894 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_20170309.htm 8-K acor-8k_20170309.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 9, 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 9, 2017, Acorda Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld all four patents challenged via the inter partes review (IPR) process. U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent) apply to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. These patents are set to expire in 2025, 2025, 2026 and 2027, respectively.

 

These patents, as well as U.S. Patent No. 5,540,938 that also pertains to AMPYRA, have also been challenged in the U.S. District Court for the District of Delaware. The Court has completed the trial of the case, but not yet issued its decision.

 

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 9, 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 9, 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 9, 2017

 

 

EX-99.1 2 acor-ex991_15.htm EX-99.1 acor-ex991_15.htm

 

EXHIBIT 99.1

 

 

CONTACT:

 

Jeff Macdonald

Acorda Therapeutics

(914) 326-5232

jmacdonald@acorda.com

 

FOR IMMEDIATE RELEASE

 

Patent Trials and Appeal Board (PTAB) Upholds Four AMPYRA® Patents

 

 

ARDSLEY, N.Y. – (March 9, 2017) – Acorda Therapeutics, Inc. (Nasdaq: ACOR ) today announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld all four patents challenged via the inter partes review (IPR) process. U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent) apply to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. These patents are set to expire in 2025, 2025, 2026 and 2027, respectively.

 

“The court decision reflects the merits of the case we presented and the validity and strength of our intellectual property for AMPYRA,” said Ron Cohen, M.D., Acorda's President and CEO. “Medical innovation depends on the recognition of valid intellectual property claims. Our in-house legal team and external counsel presented a compelling case, and will continue to defend the validity of our intellectual property rights for AMPYRA.”

 

Acorda was advised by Gerald Flattmann, Naveen Modi, Thomas Phalen, Michael Stamiello, Daniel Zeilberger, and Lucas Kressel of Paul Hastings LLP.

 

These patents, as well as U.S. Patent No. 5,540,938 that also pertains to AMPYRA, have also been challenged in the U.S. District Court for the District of Delaware. The Court has completed the trial of the case, but not yet issued its decision.

 

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

This press release includes forward-looking statements. 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: 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.; 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.

 

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

 

###

 

 

 

GRAPHIC 3 g2017030921181450930776.jpg GRAPHIC begin 644 g2017030921181450930776.jpg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end