Humanigen, Inc. (Nasdaq: HGEN), a clinical-stage biopharmaceutical company specializing in the prevention and treatment of an overactive immune response called “cytokine shock,” today announced that lenzilumab is now available for select patients. patients with COVID-19 through its new Managed Access Program (“LenzMAP™”). Clinigen Group plc (“Clinigen”), a global pharmaceuticals and services company, is currently implementing the program. Lenzilumab is an investigational product that is not currently licensed or approved in any country.
Clinigen are experts in providing specialist therapies to named patients in the UK and Europe.
Lenzilumab is available through LenzMAP in the following 17 countries:
Austria
Bulgaria
Croatia
Cyprus
Denmark
Estonia
France
Greece
Ireland
Lithuania
Luxemburg
Netherlands
Portugal
Spain
Sweden
Swiss
UK
LenzMAP will make access to lenzilumab possible on a case-by-case basis for certain hospitalized patients with COVID-19 for whom the treating physician believes there is no suitable alternative and when regulations permit.
“We are delighted to work with Clinigen to provide access to lenzilumab on a case-by-case basis in the UK and certain other European countries,” said Timothy E. Morris, Chief Operating Officer and Chief Financial Officer of Humanigen. “As we continue our development program for lenzilumab and seek appropriate clearances or approvals for its potential commercial use in the United States, European Union and United Kingdom, LenzMAP will enable Humanigen to meet requests from healthcare professionals who wish to access lenzilumab to treat certain hospitalized patients when authorized 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 to bring this potential treatment alternative to certain hospitalized patients with COVID-19 in the UK and the rest of Europe. LenzMAP underscores Clinigen’s demonstrated ability to work in partnership with biotech companies to provide services that enable faster and broader access to essential medicines,” commented Pete Belden, Vice Executive Chairman of the Services Division of Clinigen.
Clinigen currently oversees more than 161 similar managed access programs for other companies, and works with more than 20,000 healthcare providers at 5,000 hospitals in more than 12 countries.
“As we move from pandemic to endemic with COVID-19, healthcare professionals continue to see vaccinated and unvaccinated patients arrive with acute inflammatory symptoms,” said Dr. Andrea Aroldi, MD, of the San Gerardo Hospital (Monza, Italy). “Now that lenzilumab is available for compassionate use/on a case-by-case basis for named patients in certain European countries, physicians have an additional treatment alternative, an immunomodulator, in their treatment arsenal against COVID-19. »
Healthcare professionals can obtain information about LenzMAP™ by calling the Clinigen Customer Service team on +44 (0) 1932 824100, emailing [email protected] or visiting www.clinigendirect .com.
Patients seeking medical information are advised to contact their physician.
About Humanigen
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company specializing in the prevention and treatment of an overactive immune response called “cytokine shock”. Lenzilumab is a first-in-class antibody that binds and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate that GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in cytokine shock. In addition to developing lenzilumab as a treatment for cytokine shock associated with COVID-19 and CAR-T cell therapies targeting COVID-19, Humanigen is exploring the efficacy of lenzilumab in other inflammatory conditions, such as acute disease. graft versus host in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma and rheumatoid arthritis. To learn more, please visit www.humanigen.com, and follow us on LinkedIn, Twitter and Facebook.
About Clinigen
Clinigen Group plc (AIM: CLIN) is a global specialty 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 based in North America, Europe, Africa and Asia-Pacific. Clinigen has more than 1,000 employees across five continents in 14 countries, with operational supply, distribution and centers of excellence in key regions with long-term growth prospects. The Group works with 34 of the 50 largest pharmaceutical companies, interacting with more than 5,000 hospitals in more than 120 countries. For more information about Clinigen, visit http://www.clinigen.com.
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