Acorda Receives Refusal to File Letter from FDA for INBRIJA™ (CVT-301, levodopa inhalation powder) New Drug Application

ARDSLEY, N.Y.–([1])–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
received a Refusal to File (RTF) letter from the U.S. Food and Drug
Administration (FDA) regarding its New Drug Application (NDA) for
INBRIJA. INBRIJA is an investigational treatment for symptoms of OFF
periods in people with Parkinson’s disease taking a carbidopa/levodopa
regimen.

Upon its preliminary review, FDA determined that the NDA, submitted on
June 26, 2017, was not sufficiently complete to permit a substantive
review. FDA specified two reasons for the RTF: first, the date when the
manufacturing site would be ready for inspection, and, second, a
question regarding the submission of the drug master production record.
FDA also requested additional information at resubmission, which was not
part of the basis for the RTF.

The Company will seek immediate guidance, including a Type A meeting
with the FDA, to respond to the issues, which it believes are
addressable, and to seek clarification of what additional information
will be required. The FDA has not requested or recommended additional
clinical efficacy or safety studies.

“We will work with the FDA as quickly as possible to address the open
issues and to clarify the path to successfully re-file our application,”
said Ron Cohen, M.D., Acorda’s President and CEO. “We remain confident
in INBRIJA’s data package and its promise as an important new therapy
for people with Parkinson’s disease. We see tremendous long-term value
in its solid clinical profile, significant commercial opportunity and
strong IP, and we remain focused on working to bring patients this
important new therapy.”

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
three 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 recently announced 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.

References

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