Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.
Pictured: Biogen signage at its headquarters in Massachusetts/iStock, JHVEPhoto
After nearly 15 years of partnership, Biogen is turning its back on its multiple sclerosis agreement with Acorda Therapeutics, returning the ex-U.S. licensing rights to Fampyra (fampiridine) to the New York–based biotech. The termination of the agreement will be effective on Jan. 1, 2025.
Under the original agreement, which was signed in June 2009, Biogen has had the exclusive license to commercialize Fampyra in international markets outside the U.S. The pharma was also responsible for all regulatory activities and clinical development of Fampyra in these markets, with Acorda being eligible for milestones and tiered, double-digit royalties.
Once the contract’s termination is complete, Acorda will no longer be entitled to royalties from Biogen, but will instead directly reap the revenues of Fampyra. Until then, the biotech will continue to receive royalties as per the 2009 agreement, which will last “until the transfer of regulatory authorizations have been completed on a country-by-country basis,” according to an SEC filing.
In a statement, Acorda president and CEO Ron Cohen said the company is “grateful to Biogen for their partnership over the last 14 years,” adding that Acorda is “excited” to bring Fampyra in-house and continue providing access to multiple sclerosis patients.
Acorda and Biogen are working on a smooth transition of Fampyra ownership, ensuring continued commercialization and supply of the therapy, according to Thursday’s press release.
Designed as a sustained-release tablet formulation, Fampyra is a broad-spectrum potassium channel blocker whose mechanism of action is still incompletely known. The drug is thought to act on demyelinated nerves, reducing the leakage of current and in turn restoring conduction along the neurons.
The drug was approved by the FDA in January 2010 and is sold in the U.S. as Ampyra. Fampyra is its brand name in all markets outside the U.S., including the European Union, New Zealand and various Asian countries.
Fampyra’s revenues have been declining in recent years. In its third-quarter earnings report, Biogen revealed that for the nine months ending in Sept. 30, 2023, Fampyra made only $67.5 million, down from $73.7 million during the same time period in 2022.
For Acorda, Ampyra has also been an asset in decline. During the first nine months of 2023, the biotech reported that Ampyra’s revenue had declined 17% from the same period the year prior. Acorda made $15.7 million in Ampyra sales in the third quarter of 2023.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
