Acorda Therapeutics Announces Agreement to Commercialize INBRIJA® in Spain
July 22 2021 - 4:01PM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
has entered into distribution and supply agreements with Esteve
Pharmaceuticals S.A (ESTEVE) to commercialize INBRIJA® 33 mg
(levodopa inhalation powder, hard capsules) in Spain. INBRIJA is
indicated in the EU for the intermittent treatment of episodic
motor fluctuations (OFF episodes) in adult patients with
Parkinson’s disease treated with a levodopa/dopa-decarboxylase
inhibitor. (1)
Under the terms of the supply agreement, ACORDA will receive a
significant double-digit percent of the selling price of INBRIJA in
Spain in exchange for supply of the product. ESTEVE will have the
exclusive distribution rights to INBRIJA in the territory and
ACORDA will supply the product to ESTEVE. ESTEVE expects to launch
INBRIJA in Spain in the fourth quarter of 2022.
According to current population estimates, there are at least
300,000 people living with Parkinson's disease in Spain, and there
is one new case per 10,000 people per year; these incidence and
prevalence rates are similar to those in the rest of
Europe.(2)
“We are delighted to enter a partnership with ESTEVE to make
INBRIJA available in Spain. This is great news for people with
Parkinson’s in Spain who are in need of therapies to treat their
OFF periods. ESTEVE has an impressive track record of successfully
commercializing pharmaceuticals in Europe for neurological and
other indications,” said Ron Cohen, M.D., President and CEO of
Acorda Therapeutics. “We are also in active discussions with
additional companies for the rights to INBRIJA in other countries
in Europe and the rest of the world.”
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.
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 AMPYRA, INBRIJA or any other products under development; the
COVID-19 pandemic, including related quarantines and travel
restrictions, and the potential for the illness to affect our
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 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 and our reverse stock split; risks related to our
workforce, including our ability to realize the expected benefits
of our corporate restructuring; risks associated with complex,
regulated manufacturing processes for pharmaceuticals, which could
affect whether we have sufficient commercial supply of INBRIJA to
meet market demand; our reliance on third-party manufacturers for
the production of commercial supplies of AMPYRA and INBRIJA;
third-party payers (including governmental agencies) may not
reimburse for the use of INBRIJA 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.; 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,
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 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.
1.
https://www.ema.europa.eu/en/documents/product-information/inbrija-epar-product-information_en.pdf.
2. The social impact of Parkinson's disease in Spain: Report by the
Spanish Foundation for the Brain. R. García-Ramos. 2016,
Neurología, págs. 401—413.
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version on businesswire.com: https://www.businesswire.com/news/home/20210722005879/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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