ARDSLEY, NY & PANAMA CITY–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) and Biopas Laboratories today announced that they have entered into distribution and supply agreements to commercialize INBRIJA® in Latin America. INBRIJA is indicated in the United States for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Under the terms of the agreements, Acorda will receive a significant double-digit percentage of INBRIJA’s selling price in Latin America in return for supplying the product. Acorda will also receive milestones based on sales. Biopas will hold exclusive distribution rights for INBRIJA in nine Latin American countries, including Brazil and Mexico. According to current population estimates, at least 400,000 people live with Parkinson’s disease in Latin America1. Biopas plans to seek marketing authorization in all countries to make Inbrija available to patients as soon as possible.
“BIOPAS is the leading commercializer of CNS therapies in Latin America and we are delighted to announce these agreements to make INBRIJA available there for people with Parkinson’s disease who experience OFF periods,” said Ron Cohen. , MD, President and CEO of Acorda Therapeutics. “We are also in active discussions with other companies for the commercialization rights of INBRIJA in other countries.”
“We are delighted to partner with Acorda to make INBRIJA available to people with Parkinson’s disease in Latin America. This important partnership supports Biopas’ mission to cover the unmet medical needs of patients from Argentina to Mexico. Inbrija further strengthens Biopas’ comprehensive and innovative CNS portfolio, now comprised of nine original treatments: for Parkinson’s disease, epilepsy, movement disorders, sialorrhea, multiple sclerosis, anxiety and sleep disorders said Pascal Forget, CEO of Biopas.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for the intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA should not be used by patients who are taking or have taken a non-selective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the past two weeks. INBRIJA uses Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication by inhalation. Acorda also markets the AMPYRA brand® (dalfampridine) Extended Release Tablets, 10 mg.
About Biopas Laboratories
Biopas is a leading and differentiated Latin American pharmaceutical company, focused on the licensing, marketing and sales of advanced specialty pharmaceutical products. Biopas offers best-in-class capabilities in sales, marketing, medical, support functions and provides comprehensive services to support product launch and development. All its functions operate in compliance with international standards and regulations. Biopas covers more than 20 countries in Latin America through wholly owned subsidiaries and is a trusted partner of reputable multinational pharmaceutical companies, and has products with leading positions in CNS, Immunology, Rare Diseases , oncology and dermatology.
Forward-looking statements
This press release contains forward-looking statements. All statements, other than statements of historical fact, regarding the expectations, beliefs, objectives, plans or prospects of Acorda’s management should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: Acorda may not be able to successfully commercialize AMPYRA, INBRIJA or any other product under development ; the COVID-19 pandemic, including quarantines and related travel restrictions, and the potential for the disease to affect Acorda employees or consultants or those working for other companies on which Acorda relies, could have a material adverse effect on Acorda’s business operations or product sales; Acorda’s ability to raise additional funds to fund its operations, repay outstanding debt or meet other obligations, and its ability to control costs or reduce planned expenses; the risks associated with trading in its common stock; risks relating to its workforce, including its ability to realize the expected benefits of previous corporate restructurings; risks associated with complex and regulated pharmaceutical manufacturing processes, which could affect whether it has sufficient commercial supply of INBRIJA to meet market demand; its reliance on third-party manufacturers to produce AMPYRA’s and INBRIJA’s business supplies; third-party payers (including government agencies) may not reimburse for use of INBRIJA at acceptable rates or at all and may impose restrictive pre-authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to market INBRIJA and AMPYRA outside of the United States; competition for INBRIJA and AMPYRA, including increased competition and accompanying loss of revenue in the United States from generic versions of AMPYRA (dalfampridine) following the loss of the exclusivity of the patent; the ability to realize the expected benefits of acquisitions, among other things, because acquired development programs are generally subject to all of the risks inherent in the drug development process and knowledge of the risks specifically related to acquired programs improves with time. weather ; the risk of adverse results from future studies of INBRIJA (levodopa powder for inhalation) or other research and development programs, or any other programs acquired or licensed; the occurrence of safety-related adverse events with Acorda’s products; the outcome (whether by judgment or settlement) and costs of judicial, administrative or regulatory proceedings, investigations or inspections, including, without limitation, class, representative or class action litigation; failure to protect the intellectual property rights, defend against the intellectual property claims of others, or obtain third-party intellectual property licenses necessary to market its products; and failure to comply with regulatory requirements could result in adverse action by regulators.
These and other risks are described in greater detail in Acorda’s filings with the Securities and Exchange Commission. Acorda may not achieve the objectives or plans described in its forward-looking statements, and investors should not place undue reliance on such statements. Forward-looking statements made in this press release speak only as of the date hereof, and Acorda disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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1 GBD 2016 Parkinson’s Disease Collaborators: Global, Regional and National Burden of Parkinson’s Disease, 1990-2016: A Systematic Analysis for the 2016 Global Burden of Disease Study; Lancet Neurology 2018; 17: 939–53 |
