ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR )
today announced that the United States District Court for the District
of Delaware upheld U.S. Patent No. 5,540,938 (the ‘938 patent), which
pertains to the formulation of AMPYRA® (dalfampridine)
Extended Release Tablets, 10 mg and is set to expire in July 2018. The
Court invalidated 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) which pertain to AMPYRA. The Company will appeal the
ruling on these patents.
“We are disappointed by the Court’s decision and are preparing our
appeal,” said Ron Cohen, M.D., Acorda's President and CEO, “Medical
innovation depends on the recognition of valid intellectual property
claims. We believe that we demonstrated novel and unexpected findings in
our AMPYRA development program that led to the issuance of valid
patents.”
The Company has developed contingency plans to address its business
needs and objectives in the event of a loss of AMPYRA exclusivity, and
will provide an update after finalizing the implementation timeline.
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
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., which will likely be
materially adversely affected by the court decision in our litigation
against filers of Abbreviated New Drug Applications (each, an “ANDA”) to
market generic versions of 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 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.
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Source: Acorda Therapeutics, Inc.