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Biogen quits Aduhelm, handing back rights to original developer

In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.

Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.

“Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.

“When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed,” Viehbacher added. “Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”

Up to and even after its approval, Biogen was prepared for Aduhelm to be a major product that could offset declining sales elsewhere in its business. The company earmarked $600 million to support the drug’s launch, and worked with hundreds of Alzheimer’s treatment centers to ensure patient access.

Aduhelm never succeeded commercially, though. Its approval was highly controversial, as was the price tag Biogen initially set, giving insurers leverage to push back on coverage. Importantly, the Centers for Medicare and Medicaid Services, the government insurance provider for people aged 65 and older, enacted a policy that strictly limits access to certain Alzheimer’s therapies granted so-called accelerated approval, as Aduhelm was.

These challenges proved so daunting that, by early 2022, Eisai had given up on Aduhelm and made Biogen wholly responsible for the product’s future.

The companies have since secured full approval for a related Alzheimer’s drug named Leqembi, prompting Biogen to all but abandon Aduhelm. The company recorded less than $11 million in revenue from Aduhelm over the first nine months of this year.

The company looked for possible partners or external financing for Aduhelm, but that search came up empty. It then considered the time and investment needed to keep running a large study meant to confirm the medicine’s benefits, as well as the “likely advancements” the Alzheimer’s drug field would undergo before Aduhelm might secure full approval. Biogen ultimately decided its money would be better spent elsewhere.

Biogen said a “large portion” of the resources that had been dedicated to Aduhelm will be reinvested in the company’s franchise of Alzheimer’s treatments. It plans to “accelerate” the development of potential new therapies like its experimental drugs BIIB080 and BIIB113, while also advancing Leqembi.

Eisai, which leads research and marketing for Leqembi, recently released data that could support the use of a more convenient version of the medicine. An approval filing to the Food and Drug Administration is expected by the end of March. Some analysts believe peak annual sales of Leqembi could reach $10 billion.

Biogen said that, toward the end of last year, it recorded a one-time charge of about $60 million for close-out costs related to Aduhelm.

Shares of the company were up about 1% Wednesday morning, trading around $250 apiece.

In the Wednesday statement, Biogen said it began earlier this month a “strategic review” of its research and development efforts.