Humanigen, a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyperresponse called "cytokine storm," has entered into an agreement with PCI Pharma Services (PCI), a leading integrated global contract development manufacturing organisation (CDMO), to provide importation, release and commercialisation services in the United Kingdom (UK) for lenzilumab.
Under the agreement, PCI will purchase lenzilumab for resale and distribution in the event a Conditional Marketing Authorisation is received in the UK for use in patients hospitalised with COVID-19.
“We continue our commercial preparation in the UK and in parallel are working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to address regulatory requirements for a potential Conditional Marketing Authorisation."
"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,” said Edward Jordan, Chief Commercial Officer.
“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.”
If authorised, lenzilumab will offer an important treatment option to patients hospitalised with COVID-19. Hospitalisations from COVID-19 continue in the United Kingdom with more than 235,000 admitted year-to-date and with approx. 5000 currently hospitalised.
In addition, Humanigen believes that treatment with lenzilumab may deliver economic value to the healthcare system. Previously published research has demonstrated that treatment with lenzilumab may save the National Health Service over £10,000 per patient.
Lenzilumab is an investigational product and is not approved or authorised in any country.