Biogen withdraws from Acorda pact on MS Med; The main target is on new progress engines
A number of sclerosis medication nonetheless make up the biggest share of Biogen's complete gross sales, 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 ending its partnership on the drug, the rights to which is able to revert to its developer, Acorda Therapeutics.
Biogen owns the rights to market Fampyra outdoors the U.S. beneath a partnership shaped in 2009 earlier than the drug's approval by the FDA in 2010. Acorda receives royalties from Biogen's gross sales of the drug. Pearl River, New York-based Acorda owns the U.S. rights to the product, which it sells beneath the model identify Ampyra.
Fampyra/Ampyra is a small molecule designed to dam potassium channels. Though the means by which this produces a therapeutic impact is just not but totally understood, medical exams have proven that sufferers handled with the twice-daily pill confirmed quicker strolling velocity than these given a placebo. The drug is accepted for bettering strolling in adults with MS.
In response to Acorda's annual report, Ampyra generated income of $72.9 million in 2022, down 13% from the earlier yr. Gross sales have fallen since generic variations of the drug hit the market in 2018. For Biogen, Fampyra gross sales peaked at $105.2 million in 2021, in accordance with the corporate's monetary experiences. In 2022, gross sales of the drug dropped to $96.6 million. Acorda's annual report notes that the molecule can be beneath stress from generic competitors outdoors the US.
In a submitting with regulators on Thursday, Acorda mentioned it obtained Biogen's written discover of the termination on Jan. 8. The submitting states that Biogen exercised this proper “to shift assets to approaching 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, attributable to the uncommon SOD1 mutation. Months later, Biogen agreed to the $7.3 billion acquisition of Reata Prescription drugs, which earlier this yr obtained its first FDA approval for a drug for the uncommon neuromuscular dysfunction Friedreich's ataxia.
Throughout a fireplace speech on the JP Morgan Healthcare Convention in San Francisco, Viehbacher on Monday characterised declining gross sales of Biogen's MS franchise as a “melting iceberg.” He mentioned the corporate's objective is to return to progress, shifting away from dependence on its MS medication and specializing in new progress drivers. Final month, a European Medicines Company committee really useful granting a advertising authorization for Skyclarys, Reata Friedreich's ataxia drug that analysts say has the potential for blockbuster gross sales.
“Now I feel we're truly properly positioned to return to progress, 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 the Acorda alliance will take impact in early 2025. Till then, Acorda will proceed to obtain income from Biogen's web gross sales of Fampyra. Within the regulatory submitting, Acorda mentioned the 2 corporations are engaged on a transition of Fampyra to proceed supplying the drug outdoors the US. Acorda added that it plans to imagine commercialization obligations as quickly as potential this yr as advertising authorization transfers and distribution preparations are finalized in every of the markets the place the drug is offered.
Photograph: Scott Eisen/Bloomberg, by way of Getty Pictures