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Humanigen Launches Managed Access Program for Lenzilumab
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Humanigen (Nasdaq: HGEN) announces that lenzilumab is now available for specific hospitalized COVID-19 patients through the LenzMAP™ Managed Access Program, managed by Clinigen Group. This investigational product is accessible in 17 countries, including the UK and various European nations. The program will provide lenzilumab to patients deemed appropriate by healthcare professionals where local regulations permit. As Humanigen continues to pursue regulatory approvals for lenzilumab, the partnership with Clinigen aims to facilitate access to treatment for those in need.
Positive
Lenzilumab is now available through LenzMAP for hospitalized COVID-19 patients.
Access is provided in 17 countries, enhancing treatment options for healthcare providers.
Collaboration with Clinigen enhances logistical support and regulatory management.
Negative
Lenzilumab is still an investigational product and not approved in any country.
The availability is limited to case-by-case basis, which may restrict broader access.
BURLINGAME, Calif. & DUBLIN & LONDON--(BUSINESS WIRE)--
Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced today that lenzilumab is now available for certain hospitalized COVID-19 patients through its newly-launched Managed Access Program (“LenzMAP™”). Clinigen Group plc (“Clinigen”), a global pharmaceutical Services and Products company, is implementing the program. Lenzilumab is an investigational product and is not currently authorized or approved in any country.
Clinigen is an expert in delivering specialty therapies on a named-patient basis in the UK and Europe.
Lenzilumab is available via LenzMAP in the following 17 countries:
Austria
Bulgaria
Croatia
Cyprus
Denmark
Estonia
France
Greece
Ireland
Lithuania
Luxembourg
Netherlands
Portugal
Spain
Sweden
Switzerland
United Kingdom
LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 for whom the treating physician deems there are no suitable alternatives and where regulations allow.
“We are pleased to be working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in the United Kingdom and certain other European countries,” said Timothy E. Morris, COO and CFO of Humanigen. “While we continue to pursue our development program for lenzilumab and seek to attain appropriate authorizations or approvals for its potential commercial use in the United States, European Union and United Kingdom, LenzMAP will enable Humanigen to respond to requests from healthcare professionals for access to lenzilumab to treat certain hospitalized patients where allowed by local regulations.”
Clinigen will manage key elements of LenzMAP, including regulatory oversight, reimbursement, logistics, and access management.
“We are proud to partner with Humanigen in offering this potential treatment option for certain hospitalized patients with COVID-19 in the UK and across Europe. LenzMAP underscores Clinigen’s strength in partnering with biotechnology companies to provide services that enable quicker and broader access to critical medicines,” commented Pete Belden, Executive Vice President Services Division, Clinigen.
Clinigen currently oversees more than 161 similar managed access programs for other companies and has access to over 20,000 healthcare providers in 5,000 hospitals across more than 120 countries.
“As we move from the pandemic stage to the endemic stage of COVID-19, healthcare professionals continue to see vaccinated and unvaccinated patients alike presenting with elevated inflammatory markers,” stated Andrea Aroldi, MD, San Gerardo Hospital (Monza, Italy). “Now that lenzilumab is available on a compassionate-use/named-patient basis in certain European countries, physicians have available an additional treatment option, an immunomodulator, in their armamentarium of therapies in the fight against COVID-19.”
Patients seeking medical information should contact their physician.
About Humanigen
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter, and Facebook.
About Clinigen
Clinigen Group plc (AIM: CLIN) is a global, specialist pharmaceutical services and products platform focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time. The Group operates from sites in North America, Europe, Africa, and the Asia Pacific. Clinigen has more than 1,000 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 34 of the top 50 pharmaceutical companies, interacting with over 5,000 hospitals across more than 120 countries. For more information on Clinigen, please visit http://www.clinigen.com.
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 our plans relating to lenzilumab.
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; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC.
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.
Humanigen Investor Relations
Timothy E. Morris, COO & CFO
Humanigen, Inc. tmorris@humanigen.com
+1 650-400-6874
Clinigen plc Pete Belden, EVP Services Division Rob Fox, VP Investor Relations and Corporate Development
investors@clinigengroup.com
+44 (0) 1283 495010
Consilium Strategic Communications Mary-Jane Elliott / Matthew Cole / Jessica Hodgson +44 (0) 20 3709 5700
Clinigen@consiliumcomms.com
Source: Humanigen, Inc.
FAQ
What is LenzMAP and how does it relate to HGEN?
LenzMAP is a Managed Access Program launched by Humanigen for lenzilumab, allowing access to hospitalized COVID-19 patients in 17 countries.
Which countries can access lenzilumab through LenzMAP?
Lenzilumab is available in Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, Switzerland, and the UK.
Is lenzilumab approved for use in the US?
No, lenzilumab is not currently authorized or approved in any country, including the US.
Who manages the LenzMAP program for Humanigen?
Clinigen Group plc manages the LenzMAP program, overseeing regulatory and logistical aspects.
Why is Humanigen offering lenzilumab for COVID-19 treatment?
Humanigen aims to provide treatment options for hospitalized COVID-19 patients suffering from cytokine storms.
