Biogen is cutting ties with Aduhelm, the Alzheimer’s disease drug that won a landmark but controversial regulatory approval and then became a commercial flop.
Development and commercialization of Aduhelm will be discontinued, Biogen announced Wednesday. The company is also terminating the post-marketing confirmatory study that was a condition of the therapy’s 2021 accelerated FDA approval. Aduhelm came from the labs of Swiss company Neurimmune, which licensed the drug to Biogen. Biogen has terminated that license, returning the drug’s rights to its developer.
Biogen developed Aduhelm under a neuroscience partnership with Eisai. The deal made Biogen the leader on Aduhelm development with Eisai sharing in the drug’s commercialization. In 2022, the partners amended the pact to give Biogen sole responsibility for the drug. Eisai turned its full attention to Leqembi, a different antibody Alzheimer’s disease drug that went on to win accelerated FDA approval in early 2023 and then full FDA approval about six months later. Leqembi is part of the partnership with Biogen, but Eisai is the leader on this therapy’s development and commercialization.
As the first new Alzheimer’s disease drug approved in decades, Aduhelm was projected to become a blockbuster seller. However, market uptake of the drug was weak. Some clinicians hesitated to prescribe the drug due to safety concerns. Insurance companies balked at covering the drug’s high price. A 50% price cut did little to move the needle on sales.
Most of the patients eligible for Aduhelm are Medicare beneficiaries, but this market was radically narrowed by a 2022 Centers for Medicare and Medicaid Services decision to limit coverage of the drug only to beneficiaries enrolled in a clinical trial. Biogen also encountered hurdles overseas. The company withdrew an application seeking approval of Aduhelm in Europe after an advisory body to regulators there issued a negative opinion on the drug.
With Aduhelm facing limited commercial opportunity, Biogen restructured its operations in 2022, moves that included eliminating its commercial infrastructure for the Alzheimer’s drug. The corporate shakeup led to job losses for many, including former CEO Michel Vounatsos. Under his successor, Chris Viehbacher, Biogen last year began a portfolio review that included seeking potential partners or external financing for Aduhelm. The company found no partners or financing for the drug.
In the fourth quarter of last year, Biogen recorded a $60 million charge for costs related to closing out the Aduhelm program. The company said resources that previously supported the drug will now go toward Leqembi and the development of new Alzheimer’s drugs in other therapeutic modalities. Those programs include BIIB080, an antisense oligonucleotide licensed from Ionis Pharmaceuticals that targets the tau protein. Biogen is also taking another approach to tau with BIIB113, an oral small molecule.
“As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” Viehbacher said in a prepared statement. “We plan to further advance the launch of Leqembi, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline.”
Photo: Adam Glanzman/Bloomberg, via Getty Images
