- Company to host investor webcast to
review data from INBRIJA (CVT-301) clinical program on Monday, June
5 at 4:30 pm Eastern / 1:30 pm Pacific
Acorda Therapeutics, Inc. (Nasdaq: ACOR) will present new data
from the Phase 3 clinical trial of INBRIJATM (levodopa inhalation
powder) at the International Congress of Parkinson’s Disease and
Movement Disorders (MDS), being held in Vancouver, British Columbia
from June 4-8, 2017. Acorda is developing INBRIJA (CVT-301) as a
treatment for symptoms of OFF periods in people with Parkinson’s
disease taking a carbidopa / levodopa regimen. OFF periods refer to
the re-emergence of Parkinson’s symptoms.
Data from the INBRIJA Phase 3 safety and efficacy trial, called
SPAN-PD, will be featured as a late-breaking poster:
- Inhaled levodopa (CVT-301, 84-mg
dose) significantly improves motor function during OFF periods in
Parkinson’s disease subjects: A Phase 3 Study (SPAN-PD). Data
includes primary and secondary endpoints (ABSTRACT #LBA34).
The Company previously announced positive topline data from the
SPAN-PD trial and data from two separate long-term safety studies
of INBRIJA.
“We are excited to be preparing an NDA in the U.S. and an MAA in
the EU, which we plan to submit by the end of the second quarter
and end of the year, respectively. We will present additional
findings from the Phase 3 INBRIJA study at the MDS Congress,
including key secondary measures,” said Burkhard Blank, M.D.,
Acorda's Chief Medical Officer. “Data from our clinical program
have shown that INBRIJA has the potential to be an important new
treatment option for people with Parkinson’s who experience OFF
periods, which can be extremely disruptive in their lives.”
Acorda plans to file a New Drug Application (NDA) for INBRIJA
with the U.S. Food and Drug Administration (FDA) by the end of the
second quarter of 2017, and a Marketing Authorization Application
(MAA) with the European Medicines Agency (EMA) by the end of the
year.
The Company will host a webcast for investors to provide an
overview of the INBRIJA clinical program on June 5, 2017. This will
include data being presented at the MDS Congress, as well as
additional findings from two long-term safety studies and two
special population studies.
Webcast Information
The Company will host an investor webcast to review INBRIJA data
on Monday, June 5 at 4:30 pm Eastern / 1:30 pm Pacific.
Presentations by Matthew Stern, M.D., University of Pennsylvania,
and Peter LeWitt, M.D., Wayne State University School of Medicine,
will be followed by a Q&A with Dr. Stern, Dr. LeWitt, Dr.
Donald Grosset, M.D., Queen Elizabeth University Hospital
(Scotland), Dr. Burkhard Blank, Rick Batycky, Ph.D., Acorda’s Chief
Technology Officer and Site Head, and Ron Cohen, M.D., Acorda’s
President and CEO.
The webcast will be available on the Investors Events section
of www.acorda.com. Please log in approximately 5 minutes
before the scheduled time of the presentation to ensure a timely
connection. To participate via conference call, please dial
800-806-5484 (U.S.) or 416-340-2217 (international) and reference
the access code 8170198#.
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.
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 INBRIJATM (levodopa inhalation powder)
and ARCUS®
INBRIJA (CVT-301) is a self-administered, inhaled levodopa
(L-dopa) therapy in development for the treatment of symptoms of
OFF periods in people with Parkinson’s disease taking a carbidopa /
levodopa regimen. The proprietary name INBRIJA has been
conditionally accepted by the U.S. Food and Drug
Administration (FDA).
INBRIJA utilizes Acorda’s investigational ARCUS® platform
for inhaled therapeutics. INBRIJA was designed to deliver a precise
dose of a dry powder formulation of L-dopa to the lung. Oral
medication can be associated with variable onset of action, as the
medicine is absorbed through the gastrointestinal (digestive) tract
before reaching the brain. Inhaled treatments enter the body
through the lungs and reach the brain, bypassing the digestive
system.
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,
migraine 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170518005367/en/
Acorda Therapeutics, Inc.Felicia Vonella,
914-326-5146fvonella@acorda.com
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