Market Overview

Acorda Announces EMA Validation of the MAA Submission for INBRIJA™ (levodopa inhalation powder)


Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that the
European Medicines Agency (EMA) has completed formal validation of
Acorda's Marketing Authorization Application (MAA) for INBRIJA. INBRIJA
is an investigational inhaled levodopa treatment for symptoms of OFF
periods in people with Parkinson's disease taking a carbidopa/levodopa
regimen. The INBRIJA MAA was submitted to the EMA on March 23, 2018.

The EMA review of the MAA for INBRIJA will be according to standard
timelines, with an opinion of the Committee for Medicinal Products for
Human Use (CHMP) expected within 210 days (plus any clock-stops for the
applicant to provide answers to questions which may arise during the
review). After the adoption of a CHMP opinion, a final decision
regarding the MAA is carried out by the European Commission.

The U.S. Food and Drug Administration (FDA) is currently reviewing a New
Drug Application for INBRIJA and has set an action date of October 5,
2018 under the Prescription Drug User Fee Act (PDUFA).

About Parkinson's disease and OFF periods

Approximately one million people in the U.S. and 1.2 million Europeans
are diagnosed with Parkinson's disease (PD); OFF periods are experienced
by approximately 350,000 in the U.S. and 420,000 in Europe.

Parkinson's is a progressive neurodegenerative disorder resulting from
the gradual loss of certain neurons responsible for producing dopamine.
It causes a range of symptoms including impaired movement, muscle
stiffness and tremors. As PD progresses, people with Parkinson's
experience OFF periods, which are characterized by the re-emergence of
PD symptoms. This re-emergence can occur even when an individual's
treatment regimen has been optimized.

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 acquisitions, 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; 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 (levodopa inhalation powder) 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 or any
other products under development; risks associated with complex,
regulated manufacturing processes for pharmaceuticals, which could
affect whether we have sufficient commercial supply of Inbrija to meet
market demand, if it receives regulatory approval; 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; the outcome (by judgment or settlement) and costs of legal,
administrative or regulatory proceedings, investigations or inspections,
including, without limitation, collective, representative or class
action litigation; 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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