Acorda Resubmits New Drug Application for INBRIJA™ (CVT-301, levodopa inhalation powder)

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics (Nasdaq:ACOR) announced the resubmission of its New
Drug Application (NDA) for INBRIJA to the U.S. Food and Drug
Administration (FDA). INBRIJA is an investigational treatment for
symptoms of OFF periods in people with Parkinson’s disease taking a
carbidopa/levodopa regimen.

The resubmission addressed the two issues raised in the recent Refusal
to File (RTF) letter and included all additional information requested
by the FDA in that letter.

The INBRIJA NDA is being submitted as a 505(b)(2) application. FDA is
expected to inform Acorda within 74 days if the submission has been
deemed complete and permits a full review.

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 (CVT-301, 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; 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.


Acorda Therapeutics
Felicia Vonella, 914-326-5146