Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA®
06 Novembre 2023 - 2:00PM
Business Wire
Up to five approvals expected in 2024
Additional filings expected in Chile in late
2023 and in Mexico and Brazil in 2024
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the
submission of new regulatory filings for the approval of INBRIJA®
(levodopa inhalation powder) in six countries in Latin America by
its partner Biopas Laboratories (Biopas). INBRIJA is indicated in
the United States for the intermittent treatment of OFF episodes in
adult patients with Parkinson's disease (PD) treated with
carbidopa/levodopa.
Biopas has submitted for marketing approval of INBRIJA in
Argentina, Colombia, Costa Rica, Ecuador, Panama and Peru. It
expects to submit additional regulatory filings for approval of
INBRIJA in Chile in late 2023 and in Mexico and Brazil in 2024.
“We are delighted that Biopas has submitted filings for the
approval of INBRIJA in six countries in Latin America, with up to
five approvals expected in 2024. This is an important step forward
for those living with Parkinson’s in these countries,” said Ron
Cohen, M.D., Acorda’s President and Chief Executive Officer.
“Biopas is a leader in commercializing CNS therapies in Latin
America, and we thank them for their commitment to ensuring further
access to our important medication.”
About INBRIJA
INBRIJA is an inhaled prescription levodopa medicine used to
treat the return of Parkinson’s symptoms (known as OFF episodes) in
people with Parkinson’s disease who are treated with
carbidopa/levodopa medicines. It does not replace the regular
carbidopa/levodopa medicines. INBRIJA is not to be used by people
with PD who take or have taken a nonselective monoamine oxidase
inhibitor, such as phenelzine or tranylcypromine, within the last 2
weeks. The most commons side effects of INBRIJA are cough, upper
respiratory tract infection, nausea and change in the color of
saliva or spit.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA
utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a
technology platform designed to deliver medication through
inhalation. Acorda also markets branded AMPYRA® (dalfampridine)
Extended Release Tablets, 10 mg.
About Biopas Laboratories
Biopas is a leading and differentiated Latin American
Pharmaceutical company, focused on in-licensing, marketing, and
selling cutting-edge specialty pharmaceutical products. Biopas
offers best-in-class capabilities in sales, marketing, medical,
support functions and provides integral services to support the
launch and development of innovative products reducing complexity
for its partners and unlocking sales opportunities. Biopas operates
in more than 20 countries in the Latin American region including
Mexico and Brazil through its fully owned subsidiaries. Biopas is a
trusted partner of reputable multinational pharmaceutical
companies, and has products in leading positions in CNS,
Immunology, Rare Disease, Oncology, Gastroenterology and
Dermatology.
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 that we may develop;
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 and take other
actions which are necessary for us to continue as a going concern;
risks related to the successful implementation of our business
plan, including the accuracy of our 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 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/20231106056064/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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