Humanigen, PCI Pharma Services Enter Agreement for Lenzilumab Commercialization

Late-stage clinical biopharmaceutical company, Humanigen, and global contract development and manufacturing organization (CDMO), PCI Pharma Services, have entered into an agreement for the commercialization of lenzilumab, it was announced on June 16, 2022.

Lenzilumab is a first-in-class monoclonal antibody that has been shown to neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF) associated with COVID-19 and other indications. Results from a Phase III study (LIVE-AIR) have suggested that when using lenzilumab as an early intervention it has the potential to prevent the consequences of a full-blown cytokine storm in hospitalized patients with COVID-19.

“We continue our commercial preparation in the UK [United Kingdom] and in parallel are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to address regulatory requirements for a potential Conditional Marketing Authorization. With its global reach, PCI will provide a critical function in the supply chain, by directly purchasing lenzilumab for further distribution in the UK and facilitating this key process for Humanigen,”saidEdward Jordan, chief commercial officer, Humanigen.“It is anticipated that we will complete our response to MHRA soon after the top-line results from the ACTIV-5/BET-B clinical trial with lenzilumab are received.”