Humanigen Enters into Agreement with PCI Pharma Services as Part of Preparations for Commercialization in the United Kingdom
Humanigen, Inc. (NASDAQ: HGEN) has entered into an agreement with PCI Pharma Services to facilitate the importation and commercialization of lenzilumab in the UK, pending Conditional Marketing Authorization for COVID-19 treatment. PCI will purchase the drug for resale, enhancing Humanigen's supply chain readiness. Lenzilumab could save the National Health Service over £10,000 per patient and aims to address the ongoing COVID-19 hospitalizations in the UK, which exceed 235,000 this year. Further studies are planned to explore lenzilumab's efficacy in other conditions.
- Agreement with PCI Pharma Services for lenzilumab distribution in the UK enhances supply chain.
- Potential savings of over £10,000 per patient for the National Health Service.
- Plans for further studies of lenzilumab in multiple indications.
- Lenzilumab is still an investigational product not approved in any country.
- Dependence on Conditional Marketing Authorization for commercialization.
“We continue our commercial preparation in the
If authorized, lenzilumab will offer an important treatment option to patients hospitalized with COVID-19. Hospitalizations from COVID-19 continue in the
Lenzilumab is an investigational product and is not approved or authorized in any country.
About Lenzilumab
Lenzilumab is a proprietary Humaneered® first-in-class monoclonal antibody that has been proven to neutralize GM-CSF, a cytokine of critical importance in the hyperinflammatory cascade, sometimes referred to as cytokine release syndrome, or cytokine storm, associated with COVID-19 and other indications. Lenzilumab binds to and neutralizes GM-CSF, potentially improving outcomes for patients hospitalized with COVID-19.
In CAR-T, lenzilumab successfully achieved the pre-specified primary endpoint at the recommended dose in a Phase 1b study with Yescarta® in which the overall response rate was
A study of lenzilumab is also underway for patients with chronic myelomonocytic leukemia (CMML) exhibiting RAS pathway mutations. This study builds on evidence from a Phase 1 study, conducted by
About
About
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (
Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding the potential clinical and
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration involving the company; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
References
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UK Health Security Agency . (2022,June 15 ). Healthcare inUnited Kingdom . GOV.UK Coronavirus (COVID-19) in theUK . RetrievedJune 15, 2022 , from https://coronavirus.data.gov.uk/details/healthcare -
Kilcoyne, A. et al. (2022). Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with coronavirus disease 19 (COVID-19) from the perspective of National Health Service England.
ClinicoEconomics and Outcomes Research . https://doi.org/10.2147/CEOR.S360741
Humaneered® is a trademark of
Yescarta® and Tecartus® are trademarks of Gilead Sciences, Inc., or its related companies.
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Humanigen Investor Relations
trbo@humanigen.com
650-410-3206
PCI Pharma Services Contact
tgtouchberry@we-worldwide.com / +1-212-551-4877
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