Biogen to Reallocate Resources for Alzheimer’s Disease Franchise Growth Strategy”
Biogen Inc. (Nasdaq: BIIB) has unveiled plans to strategically reallocate resources in the Alzheimer’s disease (AD) therapeutic area to drive both short-term and long-term growth. The focus will remain on advancing LEQEMBI® (lecanemab-irmb), the first FDA-approved anti-amyloid beta treatment in the United States. Additionally, efforts will be expedited for the development of potential new treatment approaches, including the ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113). The company has decided to discontinue the development and commercialization of ADUHELM® (aducanumab-avwa) 100 mg/mL injection for intravenous use and will terminate the ENVISION clinical study, unrelated to safety or efficacy concerns. Resources from the ADUHELM program termination will be redirected to strengthen Biogen’s AD franchise.
Christopher A. Viehbacher, President and CEO of Biogen, stated, “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.” A strategic review conducted in January 2023 led to this decision, considering factors such as the post-marketing confirmatory ENVISION study’s time and investment requirements and expected advancements in the field by potential ADUHELM FDA traditional approval. The company did not identify potential strategic partners or external financing during this process.
Biogen has incurred a one-time charge of around $60 million related to close-out costs for the ADUHELM program in Q4 2023. The license for aducanumab, which was acquired from Neurimmune, has been terminated, and the rights will revert to Neurimmune.
Priya Singhal, M.D., M.P.H., Head of Development at Biogen, expressed gratitude to those involved in the ADUHELM development, stating, “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.