Award Notice: Advanced Development, Scale-up, and Procurement of Ebanga

Medical countermeasures (MCM) that can be deployed in the event of a filovirus outbreak are a crucial component to the United States Government's (USGs) outbreak response plan. Biomedical Advanced Research and Development Authority (BARDA) is seeking to augment the USG?s response capabilities with therapeutics targeting filovirus disease caused by Ebola virus (EBOV), Marburg virus (MARV), or Sudan virus (SUDV). There are currently two US Food and Drug Administration (FDA) approved therapeutics for treatment of Ebola Virus Disease (EVD): Inmazeb/EB3 and Ebanga/mAb114. There are no therapeutics approved for the treatment of patients infected with SUDV or MARV. Project BioShield (PBS) funding for this contract will support all efforts required for final development to approval, post-marketing requirements and commitments, manufacturing scale-up, and procurement of Final Drug Product (FDP) to be held as vendor managed inventory (VMI) or delivered to the Strategic National Stockpile.