Acorda Therapeutics and Chance Pharmaceuticals Announce Agreement to Commercialize INBRIJA® in China
May 08 2023 - 7:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) and Hangzhou Chance
Pharmaceuticals Co. Ltd. today announced that they have entered
into distribution and supply agreements to provide INBRIJA® in
China. INBRIJA is indicated in the United States for the
intermittent treatment of episodic motor fluctuations (OFF
episodes) in adult patients with Parkinson's disease (PD) treated
with a levodopa/dopa-decarboxylase inhibitor.
Under the terms of the agreements, Acorda will receive an
up-front payment of $2.5 million, a near term milestone payment of
up to $6 million, $3 million upon regulatory approval, up to $132.5
million in sales milestones, and a fixed fee for each carton of
INBRIJA supplied to Chance. By 2030, it is estimated that China
will have approximately 5 million people with Parkinson’s disease
due to its aging population1. Chance plans to seek regulatory
authorization as quickly as possible.
Chance Pharmaceuticals is focused on developing and delivering
novel inhalation therapies. Its Founder and CEO, Donghao Chen,
Ph.D., received post-doctoral training in the laboratory of Dr. Bob
Langer at M.I.T., which invented the ARCUS® inhalation technology
used to make INBRIJA. He also worked at Advanced Inhalation
Research (AIR) and Alkermes, where he was the CMC lead for an
inhaled insulin therapy, also based on the ARCUS platform.
“Our agreement with Chance is an important milestone toward
providing INBRIJA to the world’s largest population of people with
Parkinson’s. The Chance team are experts in inhalation
technologies, and we look forward to working with them to achieve
regulatory approval and to provide this important medication in
China,” said Ron Cohen, M.D., President and CEO of Acorda
Therapeutics.
“We are excited to be collaborating with Acorda to make INBRIJA
available to people suffering from Parkinson’s disease in China.
OFF episodes have a significant impact on the lives of those living
with Parkinson’s and their families, and we are proud to be working
to bring a new treatment option to this community with unmet
medical needs,” said Donghao Chen, Ph.D., Founder and CEO of Chance
Pharmaceuticals.
About Acorda Therapeutics Acorda Therapeutics develops
therapies to restore function and improve the lives of people with
neurological disorders. INBRIJA® is approved for intermittent
treatment of OFF episodes in adults with Parkinson’s disease
treated with carbidopa/levodopa. INBRIJA is not to be used by
patients who take or have taken a nonselective monoamine oxidase
inhibitor such as phenelzine or tranylcypromine within the last two
weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary
delivery system, a technology platform designed to deliver
medication through inhalation. Acorda also markets the branded
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
About Chance Pharmaceuticals Chance Pharmaceuticals is a
clinical-stage biotechnology company focusing on the discovery,
development, and delivery of inhalation therapies for the world’s
debilitating diseases such as chronic obstructive pulmonary
disease, asthma, pulmonary arterial hypertension, and central
nervous system disorders.
For more information, please visit
http://www.chancepharmaceuticals.com.
Forward-Looking Statements 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: we may not be
able to successfully market INBRIJA, AMPYRA or any other products
under development; the COVID-19 pandemic, including related
restrictions on in-person interactions and travel, and the
potential for illness, quarantines and vaccine mandates affecting
our management, employees or consultants or those that work for
other companies we rely upon, could have a material adverse effect
on our business operations or product sales; our ability to attract
and retain key management and other personnel, or maintain access
to expert advisors; our ability to raise additional funds to
finance our operations, repay outstanding indebtedness or satisfy
other obligations, and our ability to control our costs or reduce
planned expenditures; risks associated with the trading of our
common stock; risks related to the successful implementation of our
business plan, including the accuracy of its key assumptions; risks
related to our corporate restructurings, including our ability to
outsource certain operations, realize expected cost savings and
maintain the workforce needed for continued operations; risks
associated with complex, regulated manufacturing processes for
pharmaceuticals, which could affect whether we have sufficient
commercial supply of INBRIJA or AMPYRA to meet market demand; our
reliance on third-party manufacturers for the timely production of
commercial supplies of INBRIJA and AMPYRA; third-party payers
(including governmental agencies) may not reimburse for the use of
INBRIJA or AMPYRA at acceptable rates or at all and may impose
restrictive prior authorization requirements that limit or block
prescriptions; reliance on collaborators and distributors to
commercialize INBRIJA and AMPYRA outside the U.S.; our ability to
satisfy our obligations to distributors and collaboration partners
outside the U.S. relating to commercialization and supply of
INBRIJA and AMPYRA; competition for INBRIJA and AMPYRA, including
increasing competition and accompanying loss of revenues in the
U.S. from generic versions of AMPYRA (dalfampridine) following our
loss of patent exclusivity; the ability to realize the benefits
anticipated from acquisitions because, among other reasons,
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 risk of unfavorable results from future
studies of INBRIJA (levodopa inhalation powder) or from other
research and development programs, or any other acquired or
in-licensed programs; 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; 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, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230508005309/en/
Tierney Saccavino tsaccavino@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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