Clinical-stage biopharmaceutical company Humanigen and EVERSANA have entered a partnership to make available the former’s lead drug candidate, lenzilumab, to hospitalised and hypoxic Covid-19 patients on obtaining approval.
The company is anticipating an Emergency Use Authorisation issued by the US Food and Drug Administration (FDA) as well as a BLA.
Lenzilumab is a humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody that can potentially prevent and treat cytokine storm, which can lead to acute respiratory distress syndrome in severe cases.
Humanigen CEO Cameron Durrant said: “EVERSANA shares our tireless commitment to patients.
“We’ve matched our dedication to research and development in Covid-19 with a proven commercialisation partner to ensure lenzilumab will reach patients quickly and efficiently following a potential EUA.”
Estimates show that up to 89% of hospitalised Covid-19 patients are hypoxic and at risk of cytokine storm.
According to the deal, with a EUA for lenzilumab for treating hospitalised Covid-19 patients expected, Humanigen will have urgent access to EVERSANA’s fully integrated services optimised by data and predictive analytics.
EVERSANA CEO Jim Lang said: “We stand ready to immediately activate our services spanning all disciplines of the product journey to ensure lenzilumab delivers significant patient value.