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Clinigen partners with Humanigen for Lenzilumab Managed Access Program

United Kingdom
Saturday, October 9, 2021, 16:00 Hrs  [IST]

Clinigen Group plc, the global pharmaceutical services and products company, has signed an exclusive agreement with Humanigen, Inc. (Humanigen) to implement a Managed Access Programme for lenzilumab.

Once set up the programme 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. The programme 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. 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 programme including regulatory oversight, logistics and access management.

Pete Belden, executive vice president services division, Clinigen, said: “We are pleased to partner with Humanigen to offer this important treatment option to help address a significant unmet need for hospitalized patients 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.”

Timothy E. Morris chief operating officer and chief financial officer, Humanigen, said: “While we complete 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 competent authorities. We look forward to working with Clinigen.”

Clinigen Group plc (is a global, specialist pharmaceutical services and products company focused on providing ethical access to medicines.

Humanigen is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’.

 

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