Acorda Presenting New Tozadenant Data at 2017 MDS Congress
June 06 2017 - 06:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) is presenting new data
from clinical and preclinical studies of tozadenant at the 2017
International Congress of Parkinson’s Disease and Movement
Disorders (MDS), being held in Vancouver, British Columbia from
June 4-8, 2017. Acorda is developing tozadenant as a daily
maintenance therapy to reduce OFF time for people with Parkinson’s
taking an oral carbidopa / levodopa regimen. OFF refers to the
re-emergence of Parkinson’s symptoms.
“OFF is cited by people with Parkinson’s as one of the most
challenging aspects of their disease to manage,” said Burkhard
Blank, M.D., Acorda’s Chief Medical Officer. “Tozadenant represents
a potential first-in-class treatment for Parkinson’s in the U.S.
that is being studied to reduce overall daily OFF time.”
Tozadenant data being presented at the MDS congress include:
- Associating patient impression of
improvement with efficacy endpoints in Parkinson’s disease: A
post-hoc analysis of a tozadenant study (abstract #1433)
- Tozadenant phase 3 study (TOZ-PD) in
Parkinson's disease patients with motor fluctuations: baseline
characteristics (abstract #1432)
- Efficacy of tozadenant in animal models
of non-motor symptoms of Parkinson's disease (abstract #120)
Acorda expects results from an ongoing tozadenant Phase 3
clinical trial in Q1 2018. In addition, the Company initiated an
open-label, long-term safety study in the second quarter of
2017.
About Parkinson’s Disease and OFF
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.
OFF periods can be very disruptive to the lives of people with
Parkinson’s, their families and caregivers. OFF periods can
increase in frequency and severity during the course of the
disease.
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. For more information, please visit the Company’s
website at: www.acorda.com.
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 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 INBRIJA (CVT-301, levodopa inhalation powder),
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, any other products under development,
or the products that we acquired with 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.
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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version on businesswire.com: http://www.businesswire.com/news/home/20170606005215/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
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