Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA®

Rhea-AI Summary

Acorda Therapeutics, Inc. announces the submission of new regulatory filings for the approval of INBRIJA® in six Latin American countries. Biopas Laboratories has submitted for marketing approval in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. Additional filings are expected in Chile in late 2023 and in Mexico and Brazil in 2024. Up to five approvals are expected in 2024.

Up to five approvals expected in 2024

Additional filings expected in Chile in late 2023 and in Mexico and Brazil in 2024

PEARL RIVER, N.Y.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231106056064/en/

Tierney Saccavino

(914) 326-5104

tsaccavino@acorda.com

Source: Acorda Therapeutics

FAQ

What is the name of the company that submitted the regulatory filings?

The company that submitted the regulatory filings is Biopas Laboratories.

Which countries are included in the regulatory filings for INBRIJA?

The regulatory filings for INBRIJA include Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru.

When are additional regulatory filings expected?

Additional regulatory filings are expected in Chile in late 2023 and in Mexico and Brazil in 2024.

How many approvals are expected in 2024?

Up to five approvals are expected in 2024.

What is the indication of INBRIJA in the United States?

INBRIJA is indicated for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease treated with carbidopa/levodopa.