ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the United
States Court of Appeals for the Federal Circuit, by a 2-1 vote, has
upheld the United States District Court for the District of Delaware’s
decision to invalidate four AMPYRA patents. This decision affirms the
District Court’s ruling on March 31, 2017 invalidating 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) pertaining to AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg. Acorda’s U.S. Patent
No. 5,540,938 (the ‘938 patent), previously upheld by the District
Court, expired on July 30, 2018.
“We are disappointed by the Court’s decision, as we continue to believe
that our AMPYRA patents reflected true invention and were valid. We are
reviewing the decision and will consider future options, including the
possibility of a further appeal,” said Ron Cohen, M.D., Acorda's
President and CEO. “Following the Court’s original decision in 2017, we
prepared a contingency plan that we could face generic competition,
implementing a comprehensive corporate restructuring and bolstering our
balance sheet. As a result, we are well-capitalized and fully focused on
the potential launch of INBRIJA for Parkinson’s disease.”
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical company
focused on developing therapies that restore function and improve the
lives of people with neurological disorders. Acorda has a pipeline of
novel neurological therapies addressing a range of disorders, including
Parkinson’s disease and multiple sclerosis. Acorda markets two
FDA-approved therapies, including AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg.
About INBRIJA™ (levodopa inhalation powder)
INBRIJA is a self-administered, orally inhaled levodopa (L-dopa) therapy
in development for the treatment of symptoms of OFF periods in people
with Parkinson’s disease taking a carbidopa/levodopa regimen. A New Drug
Application (NDA) for INBRIJA was accepted for review by U.S. Food and
Drug Administration in February 2018. FDA has set a target PDUFA date of
October 5, 2018.
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 acquisitions, 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; we may need to raise additional funds to
finance our 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 March 2017 court decision in our
litigation against filers of Abbreviated New Drug Applications to market
generic versions of Ampyra in the U.S.; the risk of unfavorable results
from future studies of Inbrija (levodopa inhalation powder) or from our
other research and development programs, or any other acquired or
in-licensed programs; we may not be able to complete development of,
obtain regulatory approval for, or successfully market Inbrija, or any
other products under development; risks associated with complex,
regulated manufacturing processes for pharmaceuticals, which could
affect whether we have sufficient commercial supply of Inbrija to meet
market demand, if it receives regulatory approval; third party payers
(including governmental agencies) may not reimburse for the use of
Ampyra, Inbrija or our other products at acceptable rates or at all and
may impose restrictive prior authorization requirements that limit or
block prescriptions; the occurrence of adverse safety events with our
products; the outcome (by judgment or settlement) and costs of legal,
administrative or regulatory proceedings, investigations or inspections,
including, without limitation, collective, representative or class
action litigation; 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.
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Acorda Therapeutics, Inc.
Felicia Vonella, 914-326-5146
fvonella@acorda.com
Source: Acorda Therapeutics, Inc.