Humanigen, Inc., based in New Jersey, recently partnered with PCI Pharma Services to offer importation, release and commercialization solutions in the UK for the humanized monoclonal antibody, lenzilumab, according to a press release.
“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 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," Chief Commercial Officer Edward Jordan said in the release.
The late-stage clinical biopharmaceutical company centers its studies on the prevention and treatment of the immune hyper-response called "cytokine storm."
The terms of the agreement call for PCI to acquire lenzilumab for resale and distribution purposes in the event “a Conditional Marketing Authorization is received in the UK for use in patients hospitalized with COVID-19,” a press release stated.
“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,” Jordan said.
Upon receiving approval, lenzilumab commits to offering treatment to patients battling COVID-19. UK-based hospitalizations related to the disease have summed up to more than 235,000 admissions per year.
“Humanigen believes that treatment with lenzilumab may deliver economic value to the health care system,” a press release stated. "Previously published research has demonstrated that treatment with lenzilumab may save the National Health Service over £10,000 per patient.”
Despite the deal’s approval, lenzilumab is considered an investigational product and hasn’t been approved or authorized in any territory.