Australia-based CSL Ltd, announced an exclusive licensing agreement with Indianapolis, US-based Eli Lilly and Co., for the development and commercialization of clazakizumab. Under the terms of the agreement, CSL, the originator, retains the rights to develop and commercialize the anti-interleukin-6 (IL-6) monoclonal antibody for the prevention of cardiovascular events in patients with end-stage kidney disease (ESKD). Eli Lilly is granted exclusive global rights to develop and commercialize clazakizumab for all other potential indications.

Under the deal terms, Lilly will pay CSL an upfront payment of USD 100 million and commits to clinical, regulatory, and commercial milestones, with specifics not disclosed. CSL will also receive tiered royalties on global net sales of the product for the indications managed by Lilly.

Deal context

Clazakizumab is a humanized monoclonal antibody designed to bind to and inhibit IL-6, a pro-inflammatory cytokine that plays a central role in “cytokine storm” and chronic systemic inflammation. By blocking the IL-6 signaling pathway, the molecule addresses a biological driver of diverse pathologies including autoimmune disorders, chronic kidney disease-associated inflammation, and cardiovascular complications. CSL is currently evaluating the molecule in the POSIBIL6ESKD Phase III clinical trial, which focuses on reducing major adverse cardiovascular events in patients undergoing dialysis. For Eli Lilly, the acquisition of rights to clazakizumab for broader indications aligns with its existing immunology portfolio, potentially targeting areas such as rheumatoid arthritis, giant cell arteritis, or rare inflammatory conditions where IL-6 inhibition has shown clinical utility.

The market for IL-6 inhibitors is characterized by significant competition across indications such as rheumatoid arthritis, giant cell arteritis, and various nephropathies. This agreement aligns with a broader industry trend of large-scale investments in cytokine-targeting therapies. For instance, Sanofi and Regeneron have continued to expand the reach of the IL-6 targeted Kevzara (sarilumab), while EUSA Pharma was acquired by Recordati in a EUR 750 million deal in December 2021, primarily focused on the IL-6 inhibitor Sylvant (siltuximab).

Other IL-6 targeted molecules currently in clinical development include:

  • Tocilizumab (Actemra): Developed by Roche/Genentech, currently marketed for multiple indications and in Phase III trials for expanded inflammatory applications.
  • Sarilumab (Kevzara): Developed by Sanofi and Regeneron, marketed for rheumatoid arthritis and polymyalgia rheumatica.
  • Ziltivekimab: Developed by Novo Nordisk, currently in Phase III (FLOW and ZEUS trials) for cardiovascular outcomes in patients with chronic kidney disease and atherosclerotic cardiovascular disease.
  • Olokizumab: Developed by R-Pharm, in Phase III development for rheumatoid arthritis.
  • Sirukumab: Originating from Janssen/GSK, previously investigated in Phase III for rheumatoid arthritis.