ESTEVE Launches INBRIJA® in Spain
March 07 2023 - 7:00AM
Business Wire
Acorda Therapeutics, Inc. (NASDAQ: ACOR) announced that Esteve
Pharmaceuticals, S.A. has launched 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)
As previously announced, under the terms of the supply agreement
with Esteve, Acorda will receive a significant double-digit percent
of the selling price of INBRIJA in Spain in exchange for supply of
the product.
According to data from the White Paper on Parkinson's in Spain -
published by the Ministry of Health, Social Services and Equality
and co-published by the Spanish Parkinson's Federation - this
chronic and progressive neurological disease affects at least
160,000 people in Spain. According to the Spanish Society of
Neurology (SEN), about 10,000 new cases are diagnosed each
year.(2)
“Today’s announcement is great news for people in Spain who are
living with Parkinson’s and suffer from OFF periods. Esteve is a
leader in commercializing central nervous system therapeutics in
Spain. They will be educating neurologists about providing patients
with the ability to treat their OFF periods on-demand with
INBRIJA,” said Ron Cohen, M.D., President and CEO of Acorda
Therapeutics.
Esteve launched INBRIJA in Germany in mid-2022. Acorda also
previously announced an agreement with Biopas Laboratories to
commercialize INBRIJA in the nine largest markets in Latin America,
including Mexico and Brazil. Acorda is also in active discussions
with additional companies for the rights to INBRIJA in other
countries in Europe and other parts 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 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/20230307005326/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
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