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Biogen Discontinues Development of Alzheimer's Drug Aduhelm as Rights Revert to Neurimmune

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Biogen headquarters in Cambridge, Massachusetts

NEW YORK – Biogen on Wednesday said it would discontinue development and commercialization of its controversial Alzheimer's disease drug Aduhelm (aducanumab-avwa) and reallocate resources toward its other Alzheimer's development programs.

However, it's not the last of aducanumab, which will continue to be advanced by its original developer, Zurich, Switzerland-based Neurimmune. Biogen will terminate the collaboration and license agreement that it struck with Neurimmune for global rights to the drug, at which point the rights will revert to Neurimmune.

"We are grateful for Biogen's contributions and good collaboration over many years," a Neurimmune spokesperson said in an email. "For Neurimmune, taking the lead over the future development of aducanumab is now an opportunity."

Cambridge, Massachusetts-based Biogen has struggled to market Aduhelm, despite it being the first Alzheimer's drug targeting beta-amyloid to receive an approval from the US Food and Drug Administration. The monoclonal antibody drug, developed by Biogen and Eisai after being licensed from Neurimmune in 2007, targets beta-amyloid proteins, which are a hallmark sign of Alzheimer's when they accumulate in plaques in the brain.

At one point, market analysts had estimated that Aduhelm could bring in $9 billion in peak sales. However, when Aduhelm received accelerated approval from the FDA in 2021, the milestone was mired in controversy as the agency went against a recommendation from its advisory committee to not approve the drug on inconclusive evidence. Aduhelm had demonstrated mixed results in Phase III trials, and while there was consistent data supporting that the drug reduced beta-amyloid plaque in the brain, the extent to which it succeeded in slowing cognitive decline was unclear.

In Q4 2021, the months following the FDA approval, Biogen reported only $1 million in sales for the drug, followed by $4.8 million in full-year 2022.

Biogen is slated to report full-year 2023 earnings results in February, but on Wednesday it said it recorded a one-time Q4 charge of about $60 million in closeout costs for the Aduhelm program. The impact of the Aduhelm discontinuation will be included in Biogen's 2024 financial guidance, which the company will share when it reports its Q4 and full-year 2023 financial results, a Biogen spokesperson said.

Biogen said the decision to terminate development of Aduhelm followed a strategic review of its R&D efforts that kicked off in January of last year, which included seeking potential partners or external financing for Aduhelm as the firm completed a confirmatory study, dubbed ENVISION.

"Despite an extensive process, the company did not identify potential strategic partners or external financing," Biogen said in a statement.

The firm stressed that its decision to discontinue Aduhelm is not related to safety or efficacy concerns but based on an analysis of the time and investment it would need to complete the ENVISION study and that, by the time the drug might gain traditional approval from the FDA, there would likely be other advancements in the field. At the annual JP Morgan Healthcare Conference in San Francisco earlier this month, Biogen President and CEO Christopher Viehbacher, who had hinted at an upcoming announcement regarding Aduhelm, maintained that the drug was likely effective as a treatment against Alzheimer's and described figuring out a path forward for Aduhelm as "one of the hardest business problems" he's had.

Aduhelm will no longer be commercially available beginning Nov. 1. Patients enrolled in the Phase IV postmarketing confirmatory study ENVISION, which involved monthly infusions of the drug, will have the option to remain in the study through May 1. "We have a comprehensive continuity plan in place to support the patients and physicians participating in clinical trials and those being treated with commercially available Aduhelm in the US," a company spokesperson said.

"A significant amount of research from the program has been presented and published, contributing to the scientific understanding of Alzheimer's disease," the spokesperson added.

Alzheimer's continues to be a strategic therapeutic area that Biogen expects to drive near- and long-term growth, the company stressed on Wednesday.

Biogen said it would put a "large portion" of resources formerly dedicated to Aduhelm toward advancing Leqembi (lecanemab-irmb), another anti-amyloid drug for Alzheimer's that it developed with Eisai and which has since gained traditional approval from the FDA. It will also reallocate resources to clinical-stage development programs that target another protein biomarker, tau, such as an antisense oligonucleotide in a Phase II trial, BIIB080, and an oral small molecule in a Phase I trial, BIIB113.

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

Leqembi was the second anti-amyloid Alzheimer's drug to receive accelerated approval after Aduhelm and the first to be converted to a traditional approval. Today, Eisai leads development and regulatory submissions for Leqembi, with Eisai and Biogen working together to commercialize and promote the product. Eisai has final decision-making authority for Leqembi.

Separately, Eli Lilly is seeking regulatory approval in the US for its Alzheimer's drug that targets beta-amyloid, donanemab.

Alongside its decision to discontinue development of Aduhelm, Biogen will terminate ENVISION, a confirmatory study that was designed to evaluate Aduhelm's ability to slow cognitive decline, which was a requirement of the drug's accelerated approval. Meanwhile, Neurimmune on Wednesday announced plans to continue to develop aducanumab, specifically aducanumab-based therapeutics that could be subcutaneously administered as an early intervention against Alzheimer's.

Aduhelm was injected intravenously, as is Leqembi. Biogen and Eisai are also working on a subcutaneous formulation of Leqembi.

"A subcutaneous administration is in our view clearly preferred due to the shorter time of the application process, the possibility for self-administration, and lower costs as the infrastructure for infusions are not required," a Neurimmune spokesperson said.

When asked if Neurimmune planned to seek another development or commercialization partner for the program, the spokesperson said, "It is early days, and we are excited to have aducanumab back in our pipeline." In addition to the drug's rights, Neurimmune will also obtain a clinical data package, good manufacturing practice supplies, and related manufacturing technology, the company said. Its initial focus will be to review that data package and discuss development plans for new drugs with regulators.

"We will provide updates and next steps in due course," the spokesperson said.