Acorda Discontinues Tozadenant Development Program
November 20 2017 - 7:00AM
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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Investors/Analysts:Steve Sciuto, (914) 326-5364Investor
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