ACOR Acorda Therapeutics Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 08, 2024

 

 

Acorda Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-31938	13-3831168
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
2 Blue Hill Plaza 3rd Floor
Pearl River, New York				10965
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 914 347-4300

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, par value $0.001 per share		ACOR		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 1.02 Termination of a Material Definitive Agreement.

On January 8, 2024, Acorda Therapeutics, Inc. (the “Company”) received a written notice of termination from Biogen International GmbH (“Biogen”) of the Collaboration and License Agreement, dated June 30, 2009, by and between the Company and Biogen, as amended (the “Collaboration Agreement”). Accordingly, the Company will regain global commercialization rights to FAMPYRA®(fampridine). Biogen exercised its right to terminate the Collaboration Agreement in order to shift resources towards upcoming launches and programs that align with its priorities. The termination will be effective as of January 1, 2025 (the “Termination Date”).

Under the Collaboration Agreement, Biogen was granted an exclusive license to develop and commercialize AMPYRA® (marketed by Biogen as FAMPYRA) in markets outside the U.S. FAMPYRA has been approved in a number of countries across Europe, Asia and the Americas. Biogen has responsibility for regulatory activities and clinical development of FAMPYRA in ex-U.S. markets worldwide. The Company will continue to receive double-digit tiered royalties on net sales of FAMPYRA until the transfer of regulatory authorizations have been completed on a country-by-country basis. Thereafter, the Company will receive revenues directly in markets serviced by the Company or through distributors or partners.

Effective as of the Termination Date the Collaboration Agreement will be terminated in its entirety and the license rights granted by the Company to Biogen will terminate. Following the Termination Date, the Company will not be entitled to receive any further royalty or milestone payments from Biogen. The Company and Biogen are working together toward a transition for the Company to commercialize and supply FAMPYRA for the great majority of people with multiple sclerosis outside the United States currently being served. The Company plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory.

The foregoing summary of the Collaboration Agreement is qualified in its entirety by reference to the full text of the Collaboration Agreement, which was filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on August 7, 2019 and is incorporated herein by reference.

On January 11, 2024, the Company issued a press release announcing the termination of the Collaboration Agreement. A copy of the press release is being filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
10.1	Collaboration and License Agreement between Biogen Idec International GmbH and the Registrant dated June 30, 2009 (Incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q filed on August 7, 2019).
99.1	Press Release dated January 11, 2024.
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

			Acorda Therapeutics, Inc.
Date:	January 11, 2024	By:	/s/ Michael A. Gesser
		Name: Title:	Michael A. Gesser Chief Financial Officer and Treasurer

 

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Exhibit 99.1

 

 

CONTACT:

Acorda Therapeutics

Tierney Saccavino

tsaccavino@acorda.com

FOR IMMEDIATE RELEASE

Acorda Therapeutics to Regain Global Commercialization Rights to

FAMPYRA® by January 2025

PEARL RIVER, N.Y.– January 11, 2024 – 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

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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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Document And Entity Information	Jan. 08, 2024
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Document Period End Date	Jan. 08, 2024
Entity Registrant Name	Acorda Therapeutics, Inc.
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Entity File Number	001-31938
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	13-3831168
Entity Address, Address Line One	2 Blue Hill Plaza
Entity Address, Address Line Two	3rd Floor
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Entity Address, State or Province	NY
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Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	ACOR
Security Exchange Name	NASDAQ

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