(Reuters) – Biogen will halt a post-approval study for the Alzheimer’s drug Aduhelm and return the licensing rights for the drug after failing to find a partner to lower the costs of obtaining standard approval.
The drug manufacturer said on Wednesday that it feared that new medications would enter the market before Aduhelm received standard approval.
Aduhelm, once expected to be the company’s next big blockbuster treatment, was approved in 2021 by the U.S. Food and Drug Administration through accelerated approval, sparking controversy due to the lack of clear evidence of benefit to patients.
Biogen had already abandoned the marketing of the drug in 2022 after a decision by the U.S. Medicare insurance program for adults over 65 to restrict coverage, severely limiting its use.
The company will return the Aduhelm rights to Neurimmune, from which it had licensed the drug in 2007. In the fourth quarter, it will incur a one-time charge of $60 million related to the decision to terminate the study and all Aduhelm sales efforts.
Biogen said it will now work with Japanese partner Eisai on the launch of the Alzheimer’s drug Leqembi and focus on two experimental treatments targeting 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-stage Alzheimer’s patients.
„We view the reprioritization of Aduhelm resources towards the launch of Leqembi as a positive, as it reflects the company’s true priorities for the future,“ said Evan Seigerman, analyst at BMO Capital Markets.
Biogen’s shares rose nearly 2% in morning trading.
Biogen started searching for a partner to finance Aduhelm as part of a cost-cutting strategic review in January last year, but despite extensive efforts, could not find one, the company said.
(Reporting by Leroy Leo in Bengaluru; editing by Maju Samuel and Shinjini Ganguli)