Biogen Inc, one of the leading global biotechnology companies, has announced its plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth, and the company is committed to building a leading Alzheimer’s disease franchise to address patient needs.
The company will continue to advance Leqembi (lecanemab-irmb), the first anti-amyloid beta treatment with the US FDA traditional approval in the United States, and will accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). The company also will discontinue the development and commercialization of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study. This decision is not related to any safety or efficacy concerns. A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen’s Alzheimer's Disease franchise.
“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. 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,” said Christopher A. Viehbacher, President and CEO of Biogen. “When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. ADUHELM was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
In January 2023, Biogen started a strategic review of its research and development efforts, including seeking potential partners or external financing for ADUHELM, as part of a focus on prioritizing the company’s portfolio. During this process, Biogen considered the time and investment required for the post-marketing confirmatory ENVISION study and the likely advancements in the field by the time of potential ADUHELM FDA traditional approval. Despite an extensive process, the company did not identify potential strategic partners or external financing.
Biogen has recorded a one-time charge of approximately $60 million related to close out costs for the program in the fourth quarter of 2023. Biogen licensed aducanumab from Neurimmune and has terminated that license. The rights to aducanumab will revert to Neurimmune.
“We have gained significant insight from the development of ADUHELM and will carry this forward as we continue our pioneering work in Alzheimer’s disease,” said Priya Singhal, Head of Development at Biogen. “We’d like to sincerely thank the trial investigators, healthcare providers, advocates, patients and families involved in the development of ADUHELM. We are grateful to Neurimmune for its scientific contributions and collaboration over many years.”
ADUHELM received accelerated approval from the US Food and Drug Administration in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of US FDA accelerated approval of ADUHELM.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen commercializing and co-promoting the product and Eisai having final decision-making authority.
Sick and tired of always wondering if you are being asked to pay the right price for your APIs? This empowers you with the answers you need to make the right decisions in the Global API market.
Chemxpert Database is one of the biggest and most comprehensive directories of pharma and chemicals, manufacturers, suppliers and information. Provided with current information on prices, demand and transactions, it gives you instant feedback on whether you are buying what is right and at the right time.
Start using market intelligence today and allow yourself to be in control in the API market.
Check it out today and make more informed sourcing decisions! Learn More!