Biogen Agrees to Acquire HI-BIO for $1.15 Billion

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Biogen Inc. and Human Immunology Biosciences (HI-Bio), a clinical-stage biotech company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), have entered into a definitive agreement under which Biogen will be purchasing HI-Bio for $1.15 billion upfront and up to $650 million in possible milestone payments. As of now, the transaction is expected to close in Q3 2024.

Included in the deal is HI-Bio’s lead asset, felzartamab, which is a fully human anti-CD38 monoclonal antibody that has been shown in clinical studies to reduce the number of CD38+ cells, including plasma cells and natural killer (NK) cells; as a result, it could open the door for additional applications that improve clinical outcomes for a range of immune-mediated diseases.

Felzartamab has been granted breakthrough therapy designation (BTD) and orphan drug designation (ODD) from the FDA for development in the treatment of primary membranous nephropathy (PMN); it has also received ODD for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients.

“We believe this late-stage asset, which has demonstrated impact on key biomarkers and clinical endpoints in three renal diseases with serious unmet needs, is a strategic addition to the Biogen portfolio as we continue to augment our pipeline and build on our expertise in immunology,” said Priya Singhal, MD, MPH, head of development at Biogen. “We look forward to welcoming HI-Bio employees into Biogen and, together, working to advance potential therapies for patients with rare immune diseases with high unmet need.”

When it comes to clinical trials, Phase II studies have been completed in PMN and AMR, while remaining ongoing in IgA nephropathy (IgAN). HI-Bio has indicated its intention to advance each indication to Phase III, and will presenting two abstracts at the upcoming European Renal Association (ERA) Congress in Stockholm, featuring interim data from the Phase 2 IgAN study, along with Phase II data from the AMR study in kidney transplant patients.

“With its deep development and commercialization capabilities, Biogen is in a position to accelerate the development of new medicines, including felzartamab, for patients with severe immune-mediated diseases,” noted Travis Murdoch, MD, CEO of HI-Bio. “We are excited to combine the HI-Bio team’s expertise with Biogen’s global footprint.”

Reference

Biogen Bolsters Late-Stage Pipeline, Expands Immunology Portfolio with Agreement to Acquire Human Immunology Biosciences. Biogen. May 22, 2024. Accessed May 23, 2024. https://investors.biogen.com/news-releases/news-release-details/biogen-bolsters-late-stage-pipeline-expands-immunology-portfolio