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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- It is not known if AMPYRA passes into
breast milk. Discontinue AMPYRA or nursing, taking into
consideration the importance of AMPYRA to the mother.
- 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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version on businesswire.com: http://www.businesswire.com/news/home/20151007005215/en/
Acorda Therapeutics, Inc.Jeff Macdonald,
914-326-5232jmacdonald@acorda.com
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