Acorda Therapeutics, Inc. (Nasdaq:ACOR) will present new analyses of
pharmacokinetic data from a Phase 1 clinical trial of rHIgM22, a
remyelinating antibody being studied for the treatment of multiple
sclerosis (MS), and five-year post-marketing safety data on AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg at the 31st
Congress of the European Committee for Treatment and Research in
Multiple Sclerosis (ECTRIMS). The meeting is being held in Barcelona,
Spain, October 7 - 10.
“Acorda is committed to researching novel therapies that can improve the
lives of people with multiple sclerosis. The scientific data being
presented at ECTRIMS feature new information about our investigational
and marketed MS therapies,” said Enrique Carrazana, M.D., Chief Medical
Officer of Acorda. “Our investigational compound rHIgM22 potentially
represents a completely new approach to the treatment of MS. An analysis
of pharmacokinetic data of rHIgM22 showed the drug is present in the
cerebrospinal fluid, and thus readily available to the brain. This is
one of the most promising areas of MS research.”
AMPYRA is the first and only medication approved to improve walking in
people with MS. This was demonstrated by an increase in walking speed.
AMPYRA has been used by more than 100,000 people since its approval in
2010. Long-term safety data being presented at ECTRIMS demonstrate that
the clinical profile of AMPYRA is consistent with the product label and
findings in Phase 3 studies.
“Safety Profile of Dalfampridine Extended Release in Multiple Sclerosis:
5-Year Post-Marketing Experience in the United States,” (Poster #EP1461)
will be exhibited on Friday, October 9, from 3:30 – 5:00pm. Michele
Jara, PhD, study author and Senior Director, Drug Safety and Risk
Management for Acorda, will present the poster.
“Pharmacokinetics of a CNS-Penetrating, Putative Remyelinating Human
Monoclonal Antibody, rHIgM22, in a Phase 1 Clinical Trial in Patients
with Stable Multiple Sclerosis (MS),” (Poster #661) will be exhibited on
Thursday, October 8, from 3:45 – 5:00pm. Andrew Eisen, MD, PhD, study
author and Senior Director, Translational Medicine for Acorda, will
present the poster.
More detailed information on the meeting can be found on the conference
website: http://www.ectrims-congress.eu/2015/ectrims-2015.html.
Other data from the rHIgM22 study were first presented at the 67th American
Academy of Neurology Annual Meeting.
AMPYRA (dalfampridine) Important Safety Information
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AMPYRA is contraindicated in patients with history of seizures,
moderate or severe renal impairment (CrCl ≤ 50 mL/min), or
history of hypersensitivity to AMPYRA or 4-aminopyridine.
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AMPYRA can cause seizures. The risk of seizures increases with
increasing doses. Discontinue AMPYRA and do not restart if seizure
occurs. In the post-marketing period seizures have been reported. The
majority of seizures occurred at the recommended dose, in patients
without a history of seizures, and generally within days to weeks of
starting therapy.
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AMPYRA has not been evaluated in patients with history of seizures or
with epileptiform activity on an EEG, as these patients were excluded
from clinical trials. The risk of seizures in patients with
epileptiform activity on an EEG is unknown, and could be substantially
higher than that observed in clinical studies.
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AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same. Patients should
discontinue use of any product containing 4-aminopyridine prior to
initiating AMPYRA to reduce the potential for dose-related adverse
reactions.
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AMPYRA can cause anaphylaxis and severe allergic reaction. Signs and
symptoms included respiratory compromise, urticaria, and angioedema of
the throat or tongue. If an anaphylactic or other serious allergic
reaction occurs, discontinue AMPYRA and do not restart.
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AMPYRA is cleared predominantly by the kidneys. The risk of seizures
in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown,
but AMPYRA plasma levels in these patients may approach those seen at
a dose of 15 mg twice daily, a dose that may be associated with an
increased risk of seizures; estimated CrCl should be known before
initiating AMPYRA and monitored at least annually during treatment.
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Urinary tract infections (UTIs) were reported more frequently in
controlled studies in patients receiving AMPYRA (12%) as compared to
placebo (8%). UTIs in AMPYRA-treated patients should be evaluated and
treated as clinically indicated.
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The most common adverse events (incidence ≥ 2% and at a rate greater
than the placebo rate) for AMPYRA in MS patients were urinary tract
infection, insomnia, dizziness, headache, nausea, asthenia, back pain,
balance disorder, multiple sclerosis relapse, paresthesia,
nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
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The risk of adverse events, including seizures, increases with
increasing AMPYRA doses. No additional benefit was demonstrated at
doses greater than 10 mg twice daily.
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There are no adequate and well-controlled studies of AMPYRA in
pregnant women. AMPYRA should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
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It is not known if AMPYRA passes into breast milk. Discontinue AMPYRA
or nursing, taking into consideration the importance of AMPYRA to the
mother.
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Safety and effectiveness of AMPYRA in patients younger than 18 years
have not been established.
Clinical studies of AMPYRA did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond differently
from younger subjects. Because elderly patients are more likely to have
decreased renal function, it is important to know the estimated CrCl
before initiating AMPYRA.
Please click here
for the Full Prescribing Information, also available at
ampyra.com/prescribing-information.pdf
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 preclinical 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. The mechanism by which dalfampridine exerts its
therapeutic effect has not been fully elucidated. 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 F` 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.
About MS and rHIgM22
Multiple sclerosis (MS) is a chronic, usually progressive disease in
which the immune system attacks and degrades the function of nerve
fibers in the brain and spinal cord by destroying myelin (a process
known as demyelination) and eventually the nerve fibers themselves.
Myelin is a fatty layer of membranes that insulates nerves, facilitating
the transmission of electrical impulses through nerve pathways that
control all neurological functions. In people with MS, disruption in
neurological function often leads to impairments in movement,
bowel/bladder function, vision and sexual function.
The cells that make myelin, called oligodendrocytes, can initially
repair myelin damage. As MS progresses, the ability of oligodendrocytes
to repair areas of demyelination is not sufficient to prevent permanent
neurological injury. Currently, there are no therapies that repair or
restore myelin in demyelinating diseases such as MS. If myelin is able
to be repaired, it may restore electrical conduction and may serve to
protect the exposed nerve fiber from further damage.
rHIgM22 is a recombinant human monoclonal antibody identified in the
laboratory of Moses Rodriguez, M.D. at Mayo Clinic. In preclinical
studies, rHIgM22 has been found to protect oligodendrocytes and
stimulate them to repair areas of demyelination. rHIgM22 treatment also
resulted in sustained improvements in motor activity in preclinical
models.
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 markets three FDA-approved therapies, including AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg. The Company has one of
the leading pipelines in the industry of novel neurological therapies.
Acorda is currently developing a number of clinical and preclinical
stage therapies. This pipeline addresses a range of disorders including
post-stroke walking deficits, Parkinson’s disease, epilepsy, neuropathic
pain, heart failure, MS and spinal cord injury.
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 the ability to realize the benefits anticipated from the
Civitas transaction and to successfully integrate Civitas' operations
into our operations; 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 CVT-301, Plumiaz (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 CVT-301, Plumiaz, or any other products under development; we may
need to raise additional funds to finance our expanded operations and
may not be able to do so on acceptable terms; 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 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.
These and other risks are described in greater detail in Acorda
Therapeutics' filings with the Securities and 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.
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