Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences

• Transaction to include felzartamab, a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases
• Felzartamab is an investigational anti-CD38 monoclonal antibody that, through its cell depletion approach, has demonstrated clinical proof of concept in rare immune-mediated indications, with plans to advance to Phase 3
• Proposed acquisition builds on Biogen capabilities in immunology with plans to combine Human Immunology Biosciences expertise in immune-mediated indications with Biogen’s global development and commercial experience in rare diseases
  

CAMBRIDGE, Mass. and SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Human Immunology Biosciences (HI-Bio), a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), today announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for $1.15 billion upfront and up to $650 million in potential milestone payments.

HI-Bio’s lead asset, felzartamab, is a fully human anti-CD38 monoclonal antibody that has been shown in clinical studies to selectively deplete CD38+ cells including plasma cells and natural killer, or NK, cells which may allow for additional applications that improve clinical outcomes in a broad range of immune-mediated diseases.

Felzartamab has received Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for development in the treatment of primary membranous nephropathy (PMN) and has received ODD in the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients. Phase 2 studies have been completed in PMN and AMR and remain ongoing in IgA nephropathy (IgAN), and HI-Bio has plans to advance each indication to Phase 3. HI-Bio plans to present two abstracts at the upcoming European Renal Association (ERA) Congress in Stockholm, including the complete Phase 2 data from the AMR study in kidney transplant patients and interim data from the Phase 2 IgAN study. Felzartamab has clinical data in AMR, PMN and IgAN indications.