USA – Acorda Therapeutics has regained the licensing rights for multiple sclerosis (MS) drug, Fampyra, from Biogen Inc., an American multinational biotechnology company based in Cambridge, Massachusetts, the United States.
In a release, Chief Executive Officer of Acorda Therapeutics, Dr. Ron Cohen, said: “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.”
Acknowledging elevated costs compared to its competitors, Biogen aims to redirect its focus towards higher-growth products, including Fampyra.
Biogen has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy.
Other medicines, include two co-developed treatments to address a defining pathology of Alzheimer’s disease, the first treatment to target a genetic form of ALS, the first oral treatment approved for postpartum depression, and the first approved treatment for Friedreich’s ataxia.
Taking this into account, Biogen has taken the option to return licensing rights outside of the United States to Acorda to mitigate issues with declining sales for the high-quality multiple sclerosis drug.
The restoration of rights will build on Acorda’s collaboration with Biogen for the licensing of the multiple sclerosis drug, Fampyra. The businesses collaborated on the MS drug for 15 years.
In 2021, Biogen paid Acorda US$11.7 million in royalties. The business reported revenues of US$97 million for Fampyra in 2022 and US$67 million in the first three quarters of last year.
Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
For his part, Dr. Ron Cohen confirmed that the extended-release tablet was the first of its kind upon its approval, allowing patients with MS to have improved balance and to walk better.
“The extended-release tablet was an immediate hit, generating US$141 million in U.S. sales in its first year on the market,” announced Dr. Ron Cohen.
According to the joint statement, Fampyra was approved by the United States Food and Drug Administration in 2010, six months after Acorda of Ardsley signed over its ex-U.S. rights to Biogen.
The regulatory decision comes Acorda is awaiting approval from the United States Food and Drug Administration for Parkinson’s drug as Ampyra generics loom.
Acorda, which focuses in neurological diseases, reduced its workforce by 25% in 2019 and 16% in 2021 as Ampyra sales continued to fall and high expectations for its Parkinson’s disease medication Inbrija were dashed.
In the first three quarters of last year, Acorda reported its sales at US$45 million, which was a decrease of 17% from the first three quarters of 2022.
Restoring the rights of this MS drug will allow Acorda to assume commercialization responsibilities this year as marketing authorization transfers and distribution arrangements are finalized for each territory.
Biogen’s Fampyra sales, which peaked at US$143 million in 2014, have not declined as swiftly as those of Acorda.
With effective on January 1 of 2025, the restoration of licensing rights will mark an end to a 15-year arrangement between the two biotechnology companies.