Presentation

BioArctic is a biopharma company focusing on disease-modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, with primary focus on Alzheimer’s disease and Parkinson’s disease. It was founded in 2003 based on research from Uppsala University, Sweden and is nearing a phase 3 readout (Sep2022) for its lead Alzheimer’s drug lecanemab (BAN2401) partnered with Eisai and Biogen. The company is rapidly advancing a rich R&D pipeline within multiple CNS indications and is one of few companies worldwide advancing a highly promising blood-brain-barrier (BBB) technology.

Recent highlights
In July, the US FDA has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab. Eisai’s application, which was completed in early May 2022, has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date on January 6, 2023. The acceptance of the BLA by the FDA entitles BioArctic to a milestone payment of EUR 15m from Eisai.

Outlook
According to Eisai, topline results from the Ph3 Clarity AD study with BAN2401 are expected in Sep 2022.