Biogen will end a post-approval study of Alzheimer's treatment Aduhelm and return the licensing rights on the drug after failing to find a partner to mitigate costs of obtaining standard regulatory approval.
The drugmaker said on Wednesday it was concerned that by the time Aduhelm received a standard approval, new medicines would have advanced to the market.
Aduhelm, once expected to be the company's next big blockbuster treatment, faced controversy over its accelerated approval in 2021 by the U.S. Food and Drug Administration without clear evidence of patient benefit.
Biogen had already abandoned commercialization of the drug in 2022 after a decision by the U.S. Medicare health insurance program for adults aged 65 and over to limit coverage for the drug severely restricted its use.
The company will hand back the Aduhelm rights to Neurimmune, from which it had licensed the drug in 2007. It will record a one-time charge of $60 million in the fourth quarter related to the decision to terminate the study and all Aduhelm sales efforts.
Biogen said it would now be working on the launch of Alzheimer's medicine Leqembi, with Japanese partner Eisai, and focusing on two experimental treatments that target tau, a protein associated with Alzheimer's disease.
Last year, Leqembi became the first treatment to receive standard approval for its ability to slow cognitive decline in early Alzheimer's patients.
"We see the re-prioritization of Aduhelm resources to the Leqembi launch as a positive that reflects the true priorities of the company going forward," BMO Capital Markets analyst Evan Seigerman said.
Shares of Biogen were up nearly 2% in morning trade.
Biogen started looking for a partner for financing Aduhelm in January last year as part of a strategic review to bring down costs, but could not find one despite an extensive search, the company said.
https://finance.yahoo.com/news/biogen-discontinue-development-older-alzheimers-125546765.html
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