Market Overview

Acorda Provides Update on Tozadenant Development Program

  • Identified cases of agranulocytosis, possibly drug-related, in some
    cases associated with sepsis and death
  • Increased blood cell count monitoring to weekly in ongoing Phase 3
  • Discussions with FDA and DSMB ongoing
  • Conference call today at 8:30 a.m.

Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that it has
increased the frequency of blood cell count monitoring for participants
to weekly in its Phase 3 program of tozadenant for Parkinson's disease.
The Company took this action in response to cases of agranulocytosis,
possibly drug-related, and in some cases associated with sepsis and
death. Agranulocytosis is the absence of white blood cells, which fight
infection. The Company also has paused new enrollment in the long-term
safety studies, pending further discussion with the independent Data
Safety Monitoring Board (DSMB) and the United States Food and Drug
Administration (FDA).

The Phase 3 program includes an ongoing pivotal efficacy and safety
study (CL05) and two long-term safety studies (CL05 extension and CL06).

Including the previously conducted Phase 2b study, approximately 890
patients have been exposed to tozadenant and 234 have been exposed to
placebo. This corresponds to approximately 300 patient years of
tozadenant exposure and 75 patient-years of placebo. There have been
seven cases of sepsis, all in the tozadenant groups, five of which were
fatal. Four of the sepsis cases were associated with agranulocytosis,
two had no white blood cell counts available at the time of the event
and one had a high white blood cell count.

"We have taken these steps in the best interests of the safety of
patients in the tozadenant studies, which is our top priority," said Ron
Cohen, M.D., Acorda's President and CEO. "Contingent on further input
from the DSMB and FDA, we continue to expect to report efficacy and
safety results of the double-blind Phase 3 study in the first quarter of

The Company will host a conference call today at 8:30 a.m. ET. To
participate, please dial (866) 393-4306 or (734) 385-2616 and reference
the access code 7587067. A replay of the call will be available from
11:30 a.m. ET on November 15, 2017 until 2:59 p.m. ET on December 15,
2017. To access the replay, please dial (800) 585-8367 (domestic) or
(416) 621-4642 (international) and reference the access code 7587067.
The webcast will be available in the Investor Relations section of the
Acorda website at

About Tozadenant

Tozadenant is an oral adenosine A2a receptor antagonist currently in
Phase 3 development as an adjunctive treatment to levodopa in
Parkinson's disease patients to reduce OFF time. A2a receptor
antagonists have the potential to be the first new class of drug
approved in the U.S. for improvement of motor symptoms in Parkinson's
disease in over 20 years. Following a successful Phase 2b clinical
trial, published in The Lancet in 2014, Acorda is conducting a Phase 3
trial (CL05), in which tozadenant is taken for 24 weeks in addition to a
person's other Parkinson's disease therapies. The trial is being
conducted under a special protocol assessment, or SPA, from the FDA and
is comparing two of the dose arms of tozadenant, 60 mg and 120 mg which
were selected from the prior Phase 2b clinical trial, versus placebo.
The trial is assessing improvement of motor function and activities of
daily living in people with Parkinson's while taking tozadenant. Data
from this trial are expected in the first quarter of 2018. A separate
open-label, long-term safety study (CL06) commenced enrollment in April

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biopharmaceutical company
focused on developing therapies that restore function and improve the
lives of people with neurological disorders. Acorda has a pipeline of
novel neurological therapies addressing a range of disorders, including
Parkinson's disease and multiple sclerosis. Acorda markets two
FDA-approved therapies, including AMPYRA® (dalfampridine) Extended
Release Tablets, 10 mg.

Forward-Looking Statement

This press release includes forward-looking statements. 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 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 into our operations; we may need to raise
additional funds to finance our 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 March 2017 court decision
in our litigation against filers of Abbreviated New Drug Applications to
market generic versions of Ampyra in the U.S.; the risk of unfavorable
results from future studies of Inbrija (CVT-301, levodopa inhalation
powder), tozadenant or from our other research and development programs,
or any other acquired or in-licensed programs; we may not be able to
complete development of, obtain regulatory approval for, or successfully
market Inbrija, tozadenant, or any other products under development;
third party payers (including governmental agencies) may not reimburse
for the use of Ampyra, Inbrija or our other products at acceptable rates
or at all and may impose restrictive prior authorization requirements
that limit or block prescriptions; the occurrence of adverse safety
events with our products; failure to 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.

These and other risks are described in greater detail in our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this press release are made only as
of the date hereof, and we disclaim any intent or obligation to update
any forward-looking statements as a result of developments occurring
after the date of this press release.

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