Acorda Therapeutics Announces Agreement to Commercialize INBRIJA® in Germany
November 09 2021 - 3:01PM
Business Wire
- €5 million upfront payment
- Significant double-digit percent of selling price for
supply
- Additional sales-based milestones
- Commercial launch expected mid-2022
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
has entered into distribution and supply agreements with Esteve
Pharmaceuticals GmbH (ESTEVE) to commercialize INBRIJA® 33 mg
(levodopa inhalation powder, hard capsules) in Germany. 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) Acorda had previously announced an agreement
with ESTEVE to commercialize INBRIJA in Spain.
“We are delighted to announce this second commercialization
agreement with ESTEVE, which will make INBRIJA available to the
many people with Parkinson’s in Germany who would benefit from an
“as needed” treatment for their OFF periods,” said Ron Cohen, M.D.,
President and CEO of Acorda Therapeutics. “ESTEVE has an impressive
track record of successfully commercializing pharmaceuticals in
Europe for neurological and other indications. We continue to be in
active discussions with additional companies for the rights to
distribute INBRIJA in other countries in Europe and the rest of the
world.”
Under the terms of the distribution agreement, ACORDA will
receive a €5 million upfront payment, and will receive additional
sales-based milestones. ACORDA will also receive a significant
double-digit percent of the selling price of INBRIJA in Germany in
exchange for supply of the product. ESTEVE will have the exclusive
distribution rights to INBRIJA in Germany and ACORDA will supply
the product to ESTEVE. ESTEVE expects to launch INBRIJA in Germany
by mid-2022.
According to current population estimates, there are up to
400,000 people living with Parkinson's disease in Germany, and
there are 20 new cases per 10,000 people per year. (2)
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 to affect 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 and our reverse
stock split; 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 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 Nerius, M., Fink, A., Doblhammer, G. (2017) “Parkinson's disease
in Germany: prevalence and incidence based on health claims data.”
Acta Neurologica Scandinavica, 136(5), 386–392.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5655709/.
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version on businesswire.com: https://www.businesswire.com/news/home/20211109006516/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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