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.
Under the terms of the agreement, Clinigen will manage key elements of the program including regulatory oversight, logistics and access management.
https://finance.yahoo.com/news/humanigen-signs-contract-clinigen-lenzilumab-060000913.html
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