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/
Copyright Business Wire 2016