A number of sclerosis medicine proceed to make up the largest chunk of Biogen’s whole income, however Fampyra is the smallest contributor from this franchise. Quickly it received’t contribute in any respect. Biogen, which is working to diversify past MS, is terminating its partnership on the drug, whose rights will revert to its developer, Acorda Therapeutics.
Biogen holds the rights to market Fampyra exterior of the U.S. underneath a 2009 collaboration struck up previous to the drug’s 2010 FDA approval. Acorda receives royalties from Biogen’s gross sales of the drug. Pearl River, New York-based Acorda holds U.S. rights to the product, which it sells underneath the model identify Ampyra.
Fampyra/Ampyra is a small molecule designed to dam potassium channels. Whereas the way in which this offers a therapeutic impact is just not totally understood, medical testing confirmed that sufferers handled with the twice-daily pill demonstrated sooner strolling speeds in comparison with these given a placebo. The drug is accepted for bettering strolling in adults with MS.
Ampyra generated $72.9 million in 2022 income, a 13% decline from the prior yr, in accordance with Acorda’s annual report. Gross sales have been sliding since generic variations of the drug entered the market in 2018. For Biogen, Fampyra’s gross sales peaked at $105.2 million in 2021, in accordance with the corporate’s monetary stories. In 2022, the drug’s gross sales slipped to $96.6 million. Acorda’s annual report notes the molecule faces strain from generic competitors exterior of the U.S. as nicely.
In a Thursday regulatory submitting, Acorda mentioned it obtained Biogen’s written discover of the termination on Jan. 8. The submitting states that Biogen exercised this proper “with the intention to shift sources in direction of upcoming launches and applications that align with its priorities.” The neuroscience drugmaker, led by new CEO Chris Viehbacher, has two new revenue-generating merchandise in its portfolio. Final Could, the FDA accepted Qalsody as a therapy for amyotrophic lateral sclerosis pushed by the uncommon SOD1 mutation. Months later, Biogen agreed to the $7.3 billion acquisition of Reata Prescription drugs, which earlier within the yr received the first FDA approval of a drug for the uncommon neuromuscular dysfunction Friedreich’s ataxia.
Talking Monday in a hearth chat through the J.P. Morgan Healthcare Convention in San Francisco, Viehbacher characterised the declining income of Biogen’s MS franchise as a “melting iceberg.” He mentioned the corporate’s goal is to return to development, shifting the corporate from a reliance on its MS medicine and towards new development drivers. Final month, a European Medicines Company committee really helpful the granting of selling authorization for Skyclarys, the Reata Friedreich’s ataxia drug that analysts have mentioned presents the potential for blockbuster gross sales.
“Now I feel we’re really well-positioned to return to development, and I feel we’re in a a lot better place than we had been a yr in the past,” Viehbacher mentioned.
Biogen’s termination of its Acorda alliance will turn out to be efficient at first of 2025. Till then, Acorda will proceed to obtain income on Biogen’s web gross sales of Fampyra. Within the regulatory submitting, Acorda mentioned the 2 firms are working towards a transition of Fampyra to proceed the provision of the drug exterior of the U.S. Acorda added that it plans to imagine commercialization tasks as quickly as attainable this yr as advertising and marketing authorization transfers and distribution preparations are finalized in every of the markets the place the drug is offered.
Picture: Scott Eisen/Bloomberg, through Getty Photographs
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