U.S. District Court Issues Decision to Invalidate Four AMPYRA Patents; Company Will Appeal Ruling
March 31 2017 - 12:31PM
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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Acorda TherapeuticsFelicia Vonella,
917-826-3427fvonella@acorda.com
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