Humanigen, Inc. [NASDAQ: HGEN] has inked a pact with Clinigen Group plc (Clinigen) to implement a Managed Access Program for lenzilumab (LenzMAP). LenzMAP will offer the opportunity to access lenzilumab on a case-by-case basis for hospitalized COVID-19 sufferers where the doctor who treats them considers there to be no appropriate alternatives and where guidelines allow.
As per the arrangement inked between Humanigen and Clinigen, Clinigen will handle important elements of the program including regulatory oversight, logistics, and access management. Clinigen clears its stance that it is striving to eradicate the emerging virus which has affected millions of people all around the world. Clinigen considered HGEN as an important partner to fulfill its mission.
Furthermore, this pact underscores the strength of Clinigen in collaborating with biotechnology companies to offer services that allow faster and wider access to important medicines. Presently, Clinigen handles more than 161 similar managed access programs for other companies. Clinigen has access to more than 20,000 healthcare providers in 5,000 hospitals across more than 120 countries.
In addition, Humanigen will depend on the Clinigen’s professional knowledge collaborating with regulatory authorities in the respective countries to make access to lenzilumab possible in each of the 16 nations. Lenzilumab is an investigational product and is not currently authorized or accepted in any country.