Biogen is chopping ties with Aduhelm, the Alzheimer’s illness drug that gained a landmark however controversial regulatory approval after which turned a business flop.
Improvement and commercialization of Aduhelm will likely be discontinued, Biogen introduced Wednesday. The corporate can also be terminating the post-marketing confirmatory research that was a situation of the remedy’s 2021 accelerated FDA approval. Aduhelm got here from the labs of Swiss firm Neurimmune, which licensed the drug to Biogen. Biogen has terminated that license, returning the drug’s rights to its developer.
Biogen developed Aduhelm below a neuroscience partnership with Eisai. The deal made Biogen the chief on Aduhelm growth with Eisai sharing within the drug’s commercialization. In 2022, the companions amended the pact to provide Biogen sole accountability for the drug. Eisai turned its full consideration to Leqembi, a distinct antibody Alzheimer’s illness drug that went on to win accelerated FDA approval in early 2023 after which full FDA approval about six months later. Leqembi is a part of the partnership with Biogen, however Eisai is the chief on this remedy’s growth and commercialization.
As the primary new Alzheimer’s illness drug authorized in a long time, Aduhelm was projected to grow to be a blockbuster vendor. Nevertheless, market uptake of the drug was weak. Some clinicians hesitated to prescribe the drug resulting from security issues. Insurance coverage corporations balked at overlaying the drug’s excessive worth. A 50% worth reduce did little to maneuver the needle on gross sales.
Many of the sufferers eligible for Aduhelm are Medicare beneficiaries, however this market was radically narrowed by a 2022 Facilities for Medicare and Medicaid Companies resolution to restrict protection of the drug solely to beneficiaries enrolled in a medical trial. Biogen additionally encountered hurdles abroad. The corporate withdrew an software in search of approval of Aduhelm in Europe after an advisory physique to regulators there issued a destructive opinion on the drug.
With Aduhelm going through restricted business alternative, Biogen restructured its operations in 2022, strikes that included eliminating its business infrastructure for the Alzheimer’s drug. The company shakeup led to job losses for a lot of, together with former CEO Michel Vounatsos. Below his successor, Chris Viehbacher, Biogen final yr started a portfolio evaluation that included in search of potential companions or exterior financing for Aduhelm. The corporate discovered no companions or financing for the drug.
Within the fourth quarter of final yr, Biogen recorded a $60 million cost for prices associated to closing out the Aduhelm program. The corporate stated sources that beforehand supported the drug will now go towards Leqembi and the event of recent Alzheimer’s medication in different therapeutic modalities. These applications embody BIIB080, an antisense oligonucleotide licensed from Ionis Prescribed drugs that targets the tau protein. Biogen can also be taking one other strategy to tau with BIIB113, an oral small molecule.
“As a pioneer in Alzheimer’s illness, Biogen is reprioritizing sources to construct a number one franchise to deal with the a number of pathologies of the illness and affected person wants,” Viehbacher stated in a ready assertion. “We plan to additional advance the launch of Leqembi, along with Eisai, and proceed to bolster innovation with the event of the opposite property in our pipeline.”
Picture: Adam Glanzman/Bloomberg, through Getty Pictures
