$1.4M grant from Bill & Melinda Gates Foundation will address
challenges to treating premature infants in developing countries
Company to collaborate with Massachusetts Institute of Technology
ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced that the Bill & Melinda Gates Foundation has awarded the
Company a $1.4 million grant to support the development of a formulation
and delivery system for a dry powder version of lung surfactant, a drug
used to treat neonatal respiratory distress syndrome (RDS). The
formulation will be based on the Company’s proprietary ARCUS technology,
and will be produced in collaboration with the Massachusetts Institute
of Technology (MIT).
RDS is a condition affecting newborns in which fluid collects in the
lungs' air sacs; it most commonly affects infants born prematurely. It
can be fatal, or lead to severe, chronic health issues caused by a lack
of oxygen getting to the baby’s brain and other organs. The syndrome is
caused by the infants’ inability to produce enough surfactant, a liquid
lining the inside of the lungs. Delivering liquid surfactant to the
lungs via intubation is the standard of care. Intubation poses problems
in the developing world due to resource and infrastructure limitations,
including the need to refrigerate surfactant, access to sterile medical
supplies, access to potable water and a lack of healthcare professionals
trained in intubation. This grant will support the development of a
portable and easily administered inhaled form of surfactant, which may
present a more practical alternative for use in developing areas of the
world.
“Using the ARCUS technology to develop an inhaled formulation of
surfactant has the potential to expand access to this life-saving
treatment in developing countries. ARCUS-formulated medications studied
to date have been self-administered and stored at room temperature;
these features have the potential to eliminate some of the barriers that
prevent more widespread use of surfactant to treat infants with RDS,”
said Rick Batycky, Chief Technology Officer of Acorda Therapeutics. “The
ARCUS technology has a wide range of potential applications. With the
support of the Gates Foundation, we’re excited to explore this
technology to improve health outcomes for infants in areas with
constrained healthcare infrastructures. ”
“Some of the early research that led to the ARCUS technology was
conducted at MIT, so it’s very gratifying to see its continued
development,” said Robert Langer, Ph.D., David H. Koch Institute
Professor of the Massachusetts Institute of Technology. “We’re excited
that it has the potential to help newborns with RDS, where there is a
significant unmet medical need.”
ARCUS technology is used in CVT-301, an inhalable form of levodopa being
investigated by Acorda in Phase 3 trials to treat OFF episodes in people
with Parkinson’s disease. It has also been used in formulating CVT-427,
a treatment for migraines in preclinical testing. The ARCUS technology
has been used to successfully deliver more than one million doses to
patients in clinical trials of various products.
About ARCUS® Technology
Acorda’s proprietary ARCUS technology platform is a dry-powder pulmonary
delivery system that has potential applications in multiple disease
areas. This platform allows consistent and precise delivery of
significantly larger doses of medication than are possible with
conventional pulmonary systems. The ARCUS inhaler is breath-actuated,
operated by the user putting their lips to the device and simply
breathing in.
The ARCUS technology has been used to successfully deliver more than one
million doses to patients in clinical trials of various products.
CVT-301 is the most advanced drug candidate using the ARCUS technology.
Acorda has an extensive patent portfolio relating to CVT-301 and the
ARCUS technology, which covers aspects of the formulated drug product,
the inhaler, the method of drug delivery and manufacturing processes for
CVT-301.
About CVT-301
CVT-301 is being developed as a self-administered, inhaled levodopa
therapy for treatment of OFF episodes in Parkinson’s disease. This is an
adjunctive therapy to a patient’s individually optimized oral L-dopa
regimen. Acorda’s proprietary ARCUS technology provides a precise dose
of a dry powder formulation of L-dopa to the lung to enable rapid and
predictable absorption. CVT-301 is delivered through a pocket-size,
breath-actuated inhaler designed to be patient-friendly.
Based on the results of the Phase 2b trial, Acorda has initiated a Phase
3 clinical trial that is expected to enroll approximately 345
participants across three arms: 50mg, 35mg, or placebo. These are the
same doses used in the Phase 2b study. The primary outcome measure is
improvement on the UPDRS III after administration of CVT-301.
More details about the study, including enrollment criteria, can be
found at www.acorda.com or
http://clinicaltrials.gov/ct2/show/NCT02240030?term=CVT-301&rank=2
About CVT-427
CVT-427 is an inhaled triptan being investigated for the treatment of
acute migraines. The Company anticipates beginning a Phase 1 clinical
program in 2015. CVT-427 utilizes the ARCUS technology platform.
About Acorda Therapeutics
Founded in 1995, Acorda
Therapeutics is a biotechnology company focused on developing
therapies that restore function and improve the lives of people with
neurological disorders.
Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine)
Extended Release Tablets, 10 mg. The Company has one of the leading
pipelines in the industry of novel neurological therapies. Acorda is
currently developing a number of clinical and preclinical stage
therapies. This pipeline addresses a range of disorders including
post-stroke walking deficits, Parkinson’s disease, epilepsy, neuropathic
pain, heart failure, MS and spinal cord injury.
For more information, please visit the Company’s website at: www.acorda.com.
Forward Looking Statements
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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
Civitas transaction and to successfully integrate Civitas' operations
into our operations; our ability to successfully market and sell 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 CVT-301, Plumiaz, or any other acquired
or in-licensed programs; we may not be able to complete development of,
obtain regulatory approval for, or successfully market CVT-301, Plumiaz,
or any other products under development; we may need to raise additional
funds to finance our expanded operations and may not be able to do so on
acceptable terms; the occurrence of adverse safety events with our
products; delays in obtaining or failure to obtain regulatory approval
of or to successfully market Fampyra outside of the U.S. and our
dependence on our collaboration partner 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 Acorda
Therapeutics' filings with the Securities and Exchange Commission.
Acorda may not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in this
release are made only as of the date hereof, and Acorda disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this release.
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Source: Acorda Therapeutics, Inc.