On Mar. 11, 2020, Emergent BioSolutions announced it has initiated development of two product candidates for treatment and prevention of coronavirus disease (COVID-19). These product candidates are being developed on Emergent’s hyperimmune platforms that have a well-established safety database.

The hyperimmune platforms and related in-house manufacturing infrastructure support several products approved by the U.S. Food and Drug Administration, including the company’s treatments for smallpox vaccine complications, botulism, and anthrax, VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), BAT^® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], and Anthrasil^® [Anthrax Immune Globulin Intravenous (Human)], respectively.

Hyperimmunes are polyclonal antibody therapeutics derived from plasma that leverage the immune response in humans or animals and can provide immediate protection from infection. COVID-HIG, manufactured from human plasma with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients as well as protection for at-risk individuals. In parallel, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients.

Emergent has initiated plasma collection efforts for both human and equine platforms with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.

The company’s hyperimmune specialty plasma product manufacturing platform has been used to create multiple products that have obtained FDA and Health Canada approval. Emergent’s marketed antibody therapeutics, including VIG, a treatment for smallpox vaccine complications, and Anthrasil^®, a treatment for anthrax, are based on the human hyperimmune platform, while BAT^®, the company’s botulism anti-toxin, was developed on the equine hyperimmune platform.