ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is
discontinuing its clinical development program for tozadenant, an
investigational treatment for Parkinson’s disease, including immediately
discontinuing dosing of all participants currently enrolled in its
tozadenant studies. The Company made this decision based on new
information obtained from the Phase 3 program related to previously
disclosed agranulocytosis and associated serious adverse events. After
analyzing this additional information, the Company concluded that it
could not be confident that weekly white blood cell count screening
would sufficiently ensure patient safety. Acorda has informed
regulatory authorities and trial investigators regarding the orderly
closure of ongoing studies.
“Patient safety is our top priority,” said Ron Cohen, M.D., Acorda’s
President and CEO. “While we are deeply disappointed by this outcome, we
remain committed to the Parkinson’s community, which is in great need of
new therapeutic options. We are grateful to the patients who volunteered
for the tozadenant studies and to their care partners, clinical
investigators, and the internal and external study teams.”
Over 90% of the participants in the placebo-controlled Phase 3 efficacy
and safety study, CL-05, have completed the study. The Company expects
data from these participants in the first quarter of 2018 and to present
these at appropriate medical/scientific venues.
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 has an industry-leading
pipeline of novel neurological therapies addressing a range of
disorders, including Parkinson’s disease, migraine and multiple
sclerosis. Acorda markets two FDA-approved therapies, including AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg.
For more information, please visit the Company’s website at: www.acorda.com.
Forward-Looking Statement
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 Biotie and Civitas transactions, among
other reasons because acquired development programs are generally
subject to all the risks inherent in the drug development process and
our knowledge of the risks specifically relevant to acquired programs
generally improves over time; the ability to successfully integrate
Biotie’s operations and Civitas’ operations, respectively, into our
operations; we may need to raise additional funds to finance our
expanded operations and may not be able to do so on acceptable terms;
our ability to successfully market and sell Ampyra (dalfampridine)
Extended Release Tablets, 10 mg in the U.S., which will likely be
materially adversely affected by the recently announced court decision
in our litigation against filers of Abbreviated New Drug Applications
(each, an “ANDA”) to market generic versions of 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 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, any other
products under development, or the products that we will acquire when we
complete the Biotie transaction; the occurrence of adverse safety events
with our products; delays in obtaining or failure to obtain and maintain
regulatory approval of or to successfully market Fampyra outside of the
U.S. and our dependence on our collaborator 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.
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Source: Acorda Therapeutics, Inc.