Emergent BioSolutions Inc. (EBS) announced today that it was awarded a contract modification executing an option period by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at $41.9 million, for drug substance engineering and scale-up process validation, long term stability, and commercial readiness in support of its ongoing scale-up program for Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).
“Emergent is proud to continue to advance the Ebanga™ development and scale up to its next phase,” said Paul Williams, senior vice president, products business, Emergent. “We look forward to progressing the program with the goal of supplying treatment courses to enable preparedness against the Ebola virus. We believe this important work further demonstrates our position as a leader in providing critical medical countermeasures.”
The existing 10-year contract consists of a base period of performance with two option periods for advanced development valued at approximately $121 million, and option periods for procurement of Ebanga™ treatment over five years valued at up to $583 million. Execution of this option period is in line with Emergent’s planned program performance and critical path for development of the Ebanga™ treatment.
Under the terms of the contract, Emergent will complete activities to advance the development of Ebanga™ treatment through post-licensure commitments, including the transfer of technology as part of manufacturing scale-up, submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA), and completion of stability studies.
This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract 75A50123C00037.
