Acorda Announces Patent Trials and Appeal Board (PTAB) Institutes IPRs of AMPYRA Patents
March 11 2016 - 3:47PM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq:ACOR ) today announced
that the United States Patent and Trademark Office (USPTO) Patent
Trials and Appeal Board (PTAB) has instituted the inter partes
review (IPR) of 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”). A ruling on the IPR petition is
expected within one year.
The PTAB has not yet ruled on the on the petitioner’s previously
filed motion of reconsideration of the two initial IPR petitions
that were denied in August 2015.
“We believe that the findings from our extensive clinical
development program resulted in new and important discoveries
relating to the use of AMPYRA in treating multiple sclerosis,” said
Ron Cohen, M.D., president and CEO, Acorda. “We have an outstanding
internal and external legal team, and will continue to vigorously
defend our intellectual property.”
These patents are four 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. These
patents are set to expire between 2025 and 2027.
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, epilepsy, post-stroke walking deficits, migraine, and
multiple sclerosis. Acorda markets three FDA-approved therapies,
including AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
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 complete the Biotie
transaction on a timely basis or at all; 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 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, any other
products under development, or the products that we would acquire
if 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 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
release.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160311005983/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Mar 2024 to Apr 2024
Acorda Therapeutics (NASDAQ:ACOR)
Historical Stock Chart
From Apr 2023 to Apr 2024