Data to be Presented at 2014 Joint ACTRIMS-ECTRIMS Meeting
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Results from a large-scale retrospective claims database study assessing
real-world use of AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg will be presented by Acorda Therapeutics, Inc. (Nasdaq:ACOR)
and HealthCore Inc. at the 2014 Joint ACTRIMS-ECTRIMS Meeting. The study
analyzed AMPYRA prescribing patterns, adherence, and budget impact in a
managed care setting.
“Since its approval in 2010, AMPYRA has been tried by more than 90,000
people in the United States with MS, and tens of thousands are
benefiting from therapy. It is the first and only medication to be
approved to improve walking in people with MS,” said
Ron Cohen
, M.D.,
Acorda Therapeutics’ President and CEO. “These data will help us better
understand AMPYRA treatment patterns, benefits for patients, and its
potential impact on reducing other healthcare costs in a real world
setting. This information is important as part of an overall discussion
about the benefits and appropriate use of this unique therapy.”
The analysis reviewed four years of pharmacy and medical claims
utilizing HealthCore’s Integrated Research Database (HIRDSM)
associated with a large U.S. managed care plan. The analysis included
patients with a diagnosis of multiple sclerosis who initiated therapy
with AMPYRA in early 2010 through February 2012, including a
pre-treatment period starting in January 2009 and follow up period until
February 2013.
These data will be featured in a poster entitled “Treatment Patterns and
Budget Impact of Dalfampridine in Multiple Sclerosis: A Retrospective
Claims Database Analysis” (Poster #010), to be presented on Thursday,
September 11 by Acorda and HealthCore. Acorda plans to conduct
additional research utilizing real world data to further assess
long-term health economics and outcomes data for AMPYRA to improve
patient care.
The triennial Joint ACTRIMS-ECTRIMS Meeting, being held September 10-13
in Boston, brings together two of world’s leading medical associations
focused on MS research. The Americas Committee for Treatment and
Research in Multiple Sclerosis (ACTRIMS) provides leadership in the
field of multiple sclerosis and other demyelinating diseases. The
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) is an independent representative European-wide organization
devoted to MS.
AMPYRA Important Safety Information
Do not take AMPYRA if you:
-
have ever had a seizure,
-
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.
Before taking AMPYRA, tell your doctor if you:
-
have kidney problems or any other medical conditions;
-
are taking compounded 4-aminopyridine;
-
are pregnant or plan to become pregnant. It is not known if AMPYRA
will harm your unborn baby;
-
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;
-
are taking any other medicines.
Stop taking AMPYRA and call your doctor right away if you have a seizure
while taking AMPYRA. 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 before you start AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.
AMPYRA may cause serious side effects, including:
-
severe 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;
-
kidney or bladder infections.
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.
Please see Patient
Medication Guide for full safety information.
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 FAMPRYA
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
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), as demonstrated by an
increase in walking speed; 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. This
pipeline addresses 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.
About HealthCore, Inc.
HealthCore, based in Wilmington, Del., is the clinical outcomes research
subsidiary of WellPoint, Inc. HealthCore has a team of highly
experienced researchers including physicians, biostatisticians,
pharmacists, epidemiologists, health economists and other scientists who
study the “real world” safety and effectiveness of drugs, medical
devices and care management interventions. HealthCore offers insight on
how to best use this data and communicates these findings to health care
decision-makers to support evidence-based medicine, product development
decisions, safety monitoring, coverage decisions, process improvement
and overall cost-effective health care. For more information, go to www.healthcore.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 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.