Acorda Therapeutics to Regain Global Commercialization Rights to FAMPYRA® by January 2025
Acorda Therapeutics, Inc. (Nasdaq: ACOR) has announced that it will regain global commercialization rights to FAMPYRA® (fampridine) following a decision by Biogen to terminate the license and collaboration agreement between the companies, effective January 1, 2025. FAMPYRA is indicated in the European Union and other territories throughout the world for the improvement of walking in adults with multiple sclerosis (MS) with walking disability. Acorda markets the medication as AMPYRA® (dalfampridine) in the United States. Acorda and Biogen are working together toward a transition for Acorda to commercialize and supply FAMPYRA for the great majority of people with MS outside the United States currently being served. Acorda plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory. The company's President and CEO, Ron Cohen, M.D., expressed excitement about bringing FAMPYRA in-house, adding significant value to Acorda and enabling continued access to this important medication for people with MS around the world.
The announcement by Acorda Therapeutics to regain global commercialization rights to FAMPYRA represents a strategic shift in the company's business operations. With the termination of the license and collaboration agreement with Biogen, Acorda stands to gain full control over the distribution and marketing of FAMPYRA internationally. This move could potentially lead to increased revenue streams for Acorda, as they would no longer need to share profits with Biogen.
From a market perspective, the ability to directly influence the sales strategy and market penetration for FAMPYRA could result in more aggressive and targeted marketing efforts. This may lead to an expansion of the drug's market share, particularly in the European Union where it is already indicated for improving walking in adults with MS. The transition period leading up to 2025 will be critical for Acorda to establish the necessary supply chain and marketing infrastructure to support global commercialization.
Analyzing historical sales data for FAMPYRA and the competitive landscape of MS treatments will be imperative to forecast the financial impact of this decision. It's also important to monitor the execution of the transition plan and any potential regulatory hurdles that might arise during the transfer of marketing authorizations.
FAMPYRA (fampridine) is a symptomatic treatment for multiple sclerosis (MS) that improves walking in adults with walking disability. The drug's mechanism of action involves blocking potassium channels on the surface of nerve fibers, which can enhance signal conduction in damaged nerves. The clinical relevance of FAMPYRA lies in its potential to improve mobility and, by extension, the quality of life for individuals with MS.
The reacquisition of FAMPYRA's rights by Acorda Therapeutics could foster an environment for further research and development into the drug's efficacy and potential new indications. The direct control over commercialization might also enable Acorda to prioritize investment in post-marketing studies that could expand the drug's label and increase its clinical utility.
It will be important to evaluate how this strategic move affects the availability and accessibility of FAMPYRA for patients, especially during the transition period. Ensuring a seamless transition in supply is critical to avoid any disruption in treatment for current patients relying on this medication.
Acorda's reacquisition of FAMPYRA's global commercialization rights is a notable event in the healthcare market, particularly within the MS treatment space. The MS market is characterized by high unmet needs and a demand for treatments that improve day-to-day functioning. FAMPYRA's unique value proposition in enhancing walking ability could make it a key product in Acorda's portfolio.
Market dynamics, such as pricing strategies, market access and reimbursement policies, will be important factors influencing FAMPYRA's performance post-transition. Acorda's ability to navigate these complexities will be a determinant of their success in leveraging FAMPYRA's full market potential. Additionally, the competitive landscape, including the emergence of new MS treatments and the positioning of existing therapies, will impact FAMPYRA's market share.
Long-term, the success of this strategic move will depend on Acorda's commercial execution, market access capabilities and the ongoing management of relationships with healthcare providers and payers. It will be essential to monitor changes in prescribing patterns and patient outcomes to fully understand the impact of this transition on the MS treatment landscape.
01/11/2024 - 08:01 AM
PEARL RIVER, N.Y. --(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it will regain global commercialization rights to FAMPYRA® (fampridine) following a decision by Biogen to terminate the license and collaboration agreement between the companies, effective January 1, 2025. FAMPYRA is indicated in the European Union and other territories throughout the world for the improvement of walking in adults with multiple sclerosis (MS) with walking disability. Acorda markets the medication as AMPYRA® (dalfampridine) in the United States .
Acorda and Biogen are working together toward a transition for Acorda to commercialize and supply FAMPYRA for the great majority of people with MS outside the United States currently being served. Acorda plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory.
“We are excited to bring FAMPYRA in-house, which we believe will add significant value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “We are grateful to Biogen for their partnership over the last 14 years, and for their commitment to collaborating with us during this transition.”
About FAMPYRA
FAMPYRA® is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7). In clinical trials the highest incidence of adverse reactions identified with FAMPYRA given at the recommended dose was urinary tract infection. Other adverse drug reactions identified were mainly divided between neurological disorders such as insomnia, balance disorder, dizziness, paraesthesia, and headache, and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Please see FAMPYRA EPAR for more information.
About AMPYRA
AMPYRA® is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP or fampridine). AMPYRA is a potassium channel blocker approved as a treatment to help improve walking in adults with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Please see the AMPYRA Patient Medication Guide for more information.
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 INBRIJA, AMPYRA, FAMPYRA 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, AMPYRA or FAMPYRA to meet market demand; our reliance on third-party manufacturers for the production of commercial supplies of INBRIJA, AMPYRA and FAMPYRA; third-party payers (including governmental agencies) may not reimburse for the use of INBRIJA, AMPYRA or FAMPYRA 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 FAMPYRA 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 FAMPYRA; 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; competition from generic versions of FAMPYRA (dalfampridine) following patent challenges in jurisdictions outside of the U.S. ; 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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Acorda Therapeutics
tsaccavino@acorda.com
Source: Acorda Therapeutics
What is the ticker symbol for Acorda Therapeutics, Inc.?
The ticker symbol for Acorda Therapeutics, Inc. is ACOR.
What is FAMPYRA used for?
FAMPYRA is indicated for the improvement of walking in adults with multiple sclerosis (MS) with walking disability.
What is the medication marketed as in the United States?
Acorda markets the medication as AMPYRA® (dalfampridine) in the United States.
When will Acorda regain global commercialization rights to FAMPYRA?
Acorda will regain global commercialization rights to FAMPYRA effective January 1, 2025, following a decision by Biogen to terminate the license and collaboration agreement between the companies.
Who expressed excitement about bringing FAMPYRA in-house?
Ron Cohen, M.D., the President and CEO of Acorda Therapeutics, expressed excitement about bringing FAMPYRA in-house.
