BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ announced today it has entered into an arrangement with Clinigen Group plc (“Clinigen”) a global pharmaceutical Services and Products company, to implement a Managed Access Program for lenzilumab (“LenzMAP™”).
LenzMAP will enable access to lenzilumab on a case-by-case basis for hospitalized patients with COVID-19 where the treating physician deems there to be no suitable alternatives and where regulations allow. LenzMAP will be available in the following 16 European countries: Austria, Bulgaria, Croatia, Cyprus, Denmark, Estonia, France, Greece, Ireland, Lithuania, Luxembourg, Netherlands, Portugal, Spain, Sweden, and Switzerland. To date there have been over 20 million cases of COVID-19 reported in these countries.1 Lenzilumab is an investigational product and is not currently authorized or approved in any country.
“We are working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in specific European countries,” said Timothy E. Morris, COO and CFO of Humanigen. “While we continue to pursue a Marketing Authorization Application for lenzilumab and await the associated review by the European Medicines Agency, as well as a decision regarding conditional marketing authorization, the Managed Access Program will enable Humanigen to respond positively to requests for access from healthcare professionals to treat hospitalized patients where allowed by the local regulatory authorities. We look forward to working with Clinigen.”
Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.
“We are pleased to partner with Humanigen to offer this important treatment option to help address a significant unmet need for hospitalized patients with COVID-19 across Europe. This agreement underlines 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.
Humanigen will rely on Clinigen’s expertise working with regulatory authorities in the relevant countries to make access to lenzilumab possible in each of the 16 nations identified above. Clinigen currently oversees more than 161 similar managed access programs for other companies. Clinigen has access to over 20,000 healthcare providers in 5,000 hospitals across more than 120 countries.
“We remain committed to bringing lenzilumab to patients hospitalized with COVID-19 in Europe, the United Kingdom, and the United States,” said Cameron Durrant, MD, Chief Executive Officer, Humanigen. “We have completed our rolling submission for MAA to the UK’s Medicines and Healthcare Products Regulatory Agency, we are preparing our MAA to the European Medicines Agency, and we plan to submit additional data to the FDA to support potential emergency use authorization in the U.S.”
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), 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. Early in the COVID-19 pandemic, investigation showed high levels of GM-CSF secreting T cells were associated with disease severity and intensive care unit admission. Humanigen’s Phase 3 LIVE-AIR study suggests early intervention with lenzilumab may prevent consequences of a full-blown cytokine storm in hospitalized patients with COVID-19. Humanigen has submitted lenzilumab to Medicines and Health Regulatory Agency in the United Kingdom for a rolling review towards potential Marketing Authorization. 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.
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.
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 about our plans to establish and conduct the LenzMAP managed access program with Clinigen; our plans to submit an application for MAA for lenzilumab in COVID-19 with the EMA in the EU; our efforts to seek Marketing Authorization for lenzilumab in COVID-19 in the U.K.; our plans to submit additional data to FDA in support of a further submission for emergency use authorization in the U.S.; and our other plans relating to development of 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.
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- Hannah Ritchie, Edouard Mathieu, et. Al. (2020) - "Coronavirus Pandemic (COVID-19)". Published online at OurWorldInData.org. Cumulative COVID-19 Cases in Countries Retrieved from: https://ourworldindata.org/coronavirus' on Sep. 28, 2021.