Acorda to Present New Research on Novel Multiple Sclerosis and Epilepsy Therapies at American Academy of Neurology 65th Annual Meeting
Acorda Therapeutics, Inc. (Nasdaq: ACOR)
will present new research data at the 65th American Academy
of Neurology Annual Meeting on AMPYRA® (dalfampridine)
Extended Release Tablets, 10 mg, an FDA-approved therapy indicated to
improve walking in people with multiple sclerosis, and Diazepam Nasal
Spray, an investigational therapy for the treatment of cluster seizures,
also known as acute repetitive seizures, in people with epilepsy.
“Acorda is focused on improving the lives of people with neurological
disorders. We currently are developing seven therapies for a range of
conditions, including multiple sclerosis, epilepsy and spinal cord
injury,” said Ron Cohen, M.D., Acorda Therapeutics’ President and CEO.
“Our presentations at AAN include new studies on AMPYRA and the first
clinical data presented on Diazepam Nasal Spray. These studies have
increased our understanding of the potential roles these therapies could
have in addressing the urgent needs of patients with these conditions.”
Data being presented on Acorda-developed therapies at the AAN annual
meeting include:
-
Changes in Gait, Walking, and Balance Parameters After Withdrawal and
Re-initiation of Dalfampridine Extended Release Tablets in Patients
with Multiple Sclerosis: Results from the STEADY Study – P04.103 being
presented Wednesday, March 20th, 7:30am – 12:00pm
-
Safety and Efficacy of 5mg and 10mg Dalfampridine Extended Release
Tablets in Patients with Multiple Sclerosis: First Results from a
Double-Blind, Placebo-Controlled Trial – P04.096 being presented
Wednesday, March 20th, 7:30am – 12:00pm
-
Effects of 5mg and 10mg Dalfampridine Extended Release Tablets on
6-Minute Walk Distance in People with Multiple Sclerosis: A Subgroup
Analysis of a Double-Blind, Placebo-Controlled Trial – S01.007 being
presented Tuesday, March 19th at 2:30pm
-
Assessment of Pharmacokinetic Linearity and Relative Bioavailability
of a Nasal Diazepam Formulation Compared with Diazepam Rectal Gel In
Healthy Adult Subjects – P02.214 being presented Tuesday, March 19th,
7:30am – 12:00pm
More detailed information on scientific sessions and data presentations
at the AAN annual meeting can be found on the conference website (http://www.aan.com/go/am13).
Important Safety Information
Do not take AMPYRA if you have ever had a seizure or have certain types
of kidney problems.
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, including rare occurrence
of anaphylaxis.
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 AMPYRA
(dalfampridine)
AMPYRA is a potassium channel blocker approved as a treatment to improve
walking in patients with multiple sclerosis (MS). This was demonstrated
by an increase in walking speed. AMPYRA, which was previously referred
to as Fampridine-SR, is an extended release tablet formulation of
dalfampridine (4-aminopyridine, 4-AP), and is known as prolonged-,
modified, or sustained-release fampridine (FAMPYRA®) in some
countries outside the United States (U.S.).
In laboratory studies, dalfampridine extended release tablets has been
found to improve impulse conduction in nerve fibers in which the
insulating layer, called myelin, has been damaged.
AMPYRA is being developed and commercialized in the U.S. by Acorda
Therapeutics; FAMPYRA is being developed and commercialized by Biogen
Idec in markets outside the U.S. based on a licensing agreement with
Acorda. AMPYRA and FAMPYRA are manufactured globally by Alkermes Pharma
Ireland Limited, a subsidiary of Alkermes plc, based on a supply
agreement with Acorda.
AMPYRA is available by prescription in the United States. For more
information about AMPYRA, including patient assistance and co-pay
programs, healthcare professionals and people with MS can contact AMPYRA
Patient Support Services at 888-881-1918.
AMPYRA Patient Support Services is available Monday through Friday, from
8:00 a.m. to 8:00 p.m. Eastern Time. For full U.S. Prescribing
Information and Medication Guide, please visit: www.AMPYRA.com.
About Acorda
Therapeutics
Acorda Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people with MS,
spinal cord injury and other neurological conditions.
Acorda markets AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, in the United
States as a treatment to improve walking in patients with multiple
sclerosis (MS). This was demonstrated by an improvement in walking
speed. AMPYRA is marketed outside the United States as FAMPYRA®
(prolonged-release fampridine tablets) by Biogen Idec under a licensing
agreement from Acorda. AMPYRA and FAMPYRA are manufactured under license
from Alkermes Pharma Ireland Limited.
The Company also markets ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity. Acorda
also receives sales royalties on tizanidine hydrochloride capsules, an
authorized generic version of ZANAFLEX CAPSULES, distributed by Actavis,
Inc. under its agreement with Acorda.
Acorda has an industry-leading pipeline of novel neurological therapies.
The Company is developing Diazepam Nasal Spray for treatment of certain
epileptic seizures. It is also studying AMPYRA to improve a range of
functional impairments caused by MS, as well as its potential for use in
other neurological conditions, including cerebral palsy and post-stroke
deficits. In addition, Acorda is developing clinical stage compounds
AC105 for acute treatment of spinal cord injury, GGF2 for treatment of
heart failure and rHIgM22, a remyelinating monoclonal antibody, for the
treatment of MS. GGF2 is also being investigated in preclinical studies
as a treatment for neurological conditions such as stroke and spinal
cord injury. Chondroitinase, an enzyme that encourages nerve plasticity
in spinal cord injury, is in preclinical development.
Acorda 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.