ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced receipt of a Paragraph IV Certification Notice Letter
advising that Actavis Laboratories FL, Inc. submitted an Abbreviated New
Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA)
requesting permission to manufacture and market a generic version of
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
Acorda is reviewing the Notice Letter and has 45 days from the date of
receipt to commence a patent infringement lawsuit against Actavis
Laboratories FL, Inc. in order to trigger a statutory stay period under
the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA
until July 2017 at the earliest, unless a district court issues a
decision adverse to all of Acorda’s asserted Orange Book patents prior
to that date.
AMPYRA is currently protected by five patents listed in the FDA’s
Approved Drugs Product List (Orange Book), four of which extend into
2025, 2026 and 2027, respectively. AMPYRA also has Orphan Drug status,
which extends into January 2017. Acorda intends to vigorously defend its
intellectual property rights.
Acorda plans to update investors on any additional Paragraph IV
certification notices that it may receive and patent litigation against
ANDA filers in its quarterly and annual reports, including its Forms
10-Q and 10-K filed with the Securities and Exchange Commission.
The law firm of Kaye Scholer is advising Acorda on the ANDA filing.
About Acorda Therapeutics
Founded in 1995, Acorda
Therapeutics is a biotechnology company focused on developing
therapies that improve the lives of people with neurological disorders.
Acorda markets three FDA-approved therapies including: AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, a treatment
to improve walking in patients with multiple sclerosis (MS); ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity; and
Qutenza® (capsaicin) 8% Patch, for the management of
neuropathic pain associated with postherpetic neuralgia. AMPYRA is
marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda.
Acorda has one of the leading pipelines in the industry of novel
neurological therapies. The Company is currently developing six
clinical-stage therapies and one preclinical stage therapy that address
a range of disorders including post-stroke deficits, epilepsy, stroke,
peripheral nerve damage, spinal cord injury, neuropathic pain, and heart
failure. For more information, please visit the Company’s website at: www.acorda.com.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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 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 Plumiaz (our trade name for Diazepam
Nasal Spray), or any other acquired or in-licensed programs; we may not
be able to complete development of, obtain regulatory approval for, or
successfully market Plumiaz or other products under development; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain regulatory approval of or to successfully
market Fampyra outside of the U.S. and our dependence on our
collaboration partner Biogen Idec in connection therewith; competition,
including the impact of generic competition on Zanaflex Capsules
revenues; 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; failure to comply with regulatory requirements could
result in adverse action by regulatory agencies; and the ability to
obtain additional financing to support our operations. These and other
risks are described in greater detail in Acorda Therapeutics' filings
with the Securities & Exchange Commission. Acorda may not actually
achieve the goals or plans described in its 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 Acorda disclaims any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this release.
Source: Acorda Therapeutics, Inc.