Current Report Filing (8-k)
August 25 2015 - 5:04AM
Edgar (US Regulatory)
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 24, 2015
Acorda Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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000-50513 |
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13-3831168 |
(State or other jurisdiction |
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(Commission |
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(I.R.S. Employer |
of incorporation) |
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File Number) |
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Identification No.) |
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420 Saw Mill River Road,
Ardsley, NY |
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10502 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On August 24, 2015, Acorda Therapeutics, Inc. (the
Company) issued a press release announcing that the United States Patent and Trademark Office Patent Trials and Appeals Board will not institute inter partes review of U.S. Patent Nos. 8,663,685 and 8,007,826. A copy of the press release
is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference into this Item.
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated August 24, 2015 |
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.
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Acorda Therapeutics, Inc. |
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August 25, 2015 |
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By: |
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/s/ Michael Rogers |
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Name: |
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Michael Rogers |
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Title: |
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Chief Financial Officer |
EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press Release dated August 24, 2015 |
Exhibit 99.1
Acorda Announces Patent Trials and Appeal Board (PTAB) Denies Both IPRs of AMPYRA Patents
8/24/2015
ARDSLEY, N.Y.(BUSINESS WIRE) Acorda
Therapeutics, Inc. (Nasdaq:ACOR) today announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) will not institute the inter partes review (IPR) of U.S. Patent Nos. 8,663,685 (the
685 patent) and 8,007,826 (the 826 patent).
The 685 and 826 patents are two of five Orange Book-listed patents
that apply to AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, a novel treatment for multiple sclerosis (MS) developed by Acorda. AMPYRA is a standard of care for improving walking in MS. The 685 and 826 patents
are set to expire in 2025 and 2027, respectively.
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 markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda is currently developing a number of clinical and preclinical stage therapies. This pipeline addresses a range of disorders including post-stroke
walking deficits, Parkinsons disease, epilepsy, heart failure, MS and spinal cord injury.
For more information, please visit the Companys
website at: www.acorda.com.
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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 managements 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 Civitas transaction and to successfully integrate Civitas operations into our operations; our ability to successfully market and sell 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, Plumiaz, 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, Plumiaz, or any other products under development; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; the occurrence of adverse
safety events with our products; delays in obtaining or failure to obtain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaboration partner 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 Acorda
Therapeutics filings with the Securities and Exchange Commission. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements.
Forward-looking statements made in this release are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150824005968/en/
Source: Acorda Therapeutics, Inc.
Acorda Therapeutics
Jeff Macdonald, 914-326-5232
jmacdonald@acorda.com
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