Biogen returns global IP rights on Alzheimer’s drug to Neurimmune

Neurimmune is a clinical-stage biotech company that develops drug candidates for the Central Nervous System (CNS) and related protein aggregation diseases, including Alzheimer’s and Parkinson’s disease. One of its discoveries was ADUHELM (aducanumab), a human monoclonal antibody that removes amyloid beta from the brains of patients with Alzheimer’s disease. The drug was licenced to Biogen in 2007. ADUHELM received accelerated approval from the U.S. Food and Drug Administration (FDA) in June 2021. The Phase 4 post-marketing confirmatory ENVISION study was a requirement of FDA accelerated approval of ADUHELM. In the course of clinical studies for the Alzheimer’s drug ADUHELM, experts had expressed concerns over the efficacy of the drug. Now, global biotech company Biogen terminated its license for ADUHELM.

Prior to this decision, Biogen conducted 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 advancements in the field by the time of potential ADUHELM’s traditional FDA approval. Despite an extensive process, the company did not identify potential strategic partners or external financing.

The original developer, Neurimmune, now regained all IP right as well as a detailed clinical data package, GMP supplies and manufacturing technology relating to ADUHELM. Fabian Buller, Chief Business Officer of Neurimmune, comments, “We aim to develop aducanumab-based therapeutics for early intervention with a focus on subcutaneous administrations, and will provide updates on our progress in due course.”

(Press releases / SR)