ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced that the European Patent Office (EPO) Opposition
Division has upheld amended claims covering a sustained release
formulation of fampridine (known under the trade name FAMPYRA®),
also known as dalfampridine or 4-aminopyridine, for increasing walking
speed in patients with MS through twice daily dosing at 10 mg. The
decision of the Opposition Division is open to appeal.
“We are pleased that the Opposition Division has recognized the validity
of our patent claims for FAMPYRA,” said Ron Cohen, M.D., Acorda’s
President and CEO.
This European patent (EP-1 732 548 B) is set to expire in 2025, absent
any additional exclusivity granted based on regulatory review timelines.
In addition, FAMPYRA received 10-year market exclusivity upon approval
by the European Commission that is set to expire in 2021.
FAMPYRA is exclusively developed and commercialized outside the United
States by Biogen Idec under a collaboration and licensing agreement with
Acorda. FAMPYRA is indicated in the European Union for the
improvement of walking in adult patients with multiple sclerosis (MS)
with walking disability (EDSS 4-7).
FAMPYRA is the ex-U.S. trade name for AMPYRA® (dalfampridine)
Extended Release Tablets, 10mg, which is being developed and marketed in
the United States by Acorda. AMPYRA is an oral medication approved by
the U.S. Food and Drug Administration as a treatment to improve walking
in patients with MS. This was demonstrated by an increase in walking
speed.
In the United States, AMPYRA is covered by multiple patents providing
coverage through 2027. In addition, AMPYRA has Orphan drug
status providing market exclusivity through January 22, 2017.
AMPYRA Important Safety Information
Do not take AMPYRA if you have ever had a seizure, or have certain types
of kidney problems, or are allergic to dalfampridine (4-aminopyridine),
the active ingredient in AMPYRA.
Take AMPYRA exactly as prescribed by your doctor.
You could have a seizure even if you never had a seizure before. Your
chance of having a seizure is higher if you take too much AMPYRA or if
your kidneys have a mild decrease of function, which is common after age
50.
Your doctor may do a blood test to check how well your kidneys are
working, if that is not known before you start taking AMPYRA.
AMPYRA may cause serious allergic reactions. Stop taking AMPYRA and call
your doctor right away or get emergency medical help if you have
shortness of breath or trouble breathing, swelling of your throat or
tongue, or hives.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.
The most common adverse events for AMPYRA in MS patients were urinary
tract infection, trouble sleeping, dizziness, headache, nausea,
weakness, back pain, and problems with balance.
Before taking AMPYRA tell your doctor if you are pregnant or plan to
become pregnant. It is not known if AMPYRA will harm your unborn baby.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is
not known if AMPYRA passes into your breast milk. You and your doctor
should decide if you will take AMPYRA or breast-feed. You should not do
both.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
About FAMPYRA
FAMPYRA® is a prolonged-release (sustained release) tablet
formulation of the drug fampridine (4-aminopyridine, 4-AP or
dalfampridine). FAMPYRA is indicated in the European Union for the
improvement of walking in adult patients with multiple sclerosis (MS)
with walking disability (EDSS 4-7). In clinical trials the highest
incidence of adverse reactions identified with FAMPYRA given at the
recommended dose was urinary tract infection, although infection was
often not proven by culture. Other adverse drug reactions identified
were mainly divided between neurological disorders, such as insomnia,
balance disorder, dizziness, paraesthesia, headache and gastrointestinal
disorders including nausea, dyspepsia and constipation. In
post-marketing experience, there have been reports of seizure.
Confounding factors may have contributed to the occurrence of seizure in
some patients.
For more information about FAMPYRA, please visit www.biogenidec.com.
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 conditions.
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.
Forward-Looking Statements
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 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
Diazepam Nasal Spray 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.