Emergent BioSolutions Wins $41.9M Contract for Ebanga™ Ebola Treatment Development

On September 12, 2024, Emergent BioSolutions Inc. (NYSE: EBS) announced a contract modification with the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS). This modification, valued at $41.9 million, focuses on the engineering of drug substances, process validation for scale-up, long-term stability, and commercial readiness for Ebanga™ (ansuvimab-zykl), a treatment for Ebola virus disease (EVD).

Paul Williams, the Senior Vice President of Products Business at Emergent, expressed pride in advancing the development and scaling of Ebanga™. Williams emphasized Emergent's commitment to progress the program with the aim of providing treatment courses to enhance preparedness against Ebola. He believes this effort underscores Emergent's leadership in offering essential medical countermeasures.

The existing contract spans 10 years and includes a base performance period along with two optional periods for advanced development, valued at around $121 million. Additionally, there are optional periods for the procurement of Ebanga™ over five years, which could be worth up to $583 million. The execution of this option aligns with Emergent’s planned developmental trajectory for Ebanga™.

Per the contract terms, Emergent will perform activities necessary to advance Ebanga™ through post-licensure commitments. These activities include the transfer of technology for manufacturing scale-up, submitting a supplemental Biologics License Application to the FDA, and completing stability studies.

This project receives full or partial funding from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; and BARDA under contract 75A50123C00037.

Ebanga™ is a human monoclonal antibody directed at the glycoprotein of the Zaire ebolavirus (EBOV GP). It is indicated for the treatment of Zaire ebolavirus infection in both adult and pediatric patients, including newborns whose mothers are RT-PCR positive for the virus.

Limitations exist for Ebanga™'s use. Its efficacy has not been proven for other species of the Ebolavirus and Marburgvirus genera. Changes in Zaire ebolavirus, such as resistance or altered virulence, could reduce the effectiveness of antiviral drugs. It is essential to consider current drug susceptibility patterns of circulating Zaire ebolavirus strains before administering Ebanga™.

There have been reported hypersensitivity reactions associated with Ebanga™, including severe, life-threatening events during and after infusion. Patients should be closely monitored, and in cases of severe reactions, the administration of Ebanga™ should be halted immediately, with appropriate emergency care provided.

Common adverse events following the administration of Ebanga™ include fever, rapid heartbeat, diarrhea, vomiting, low blood pressure, rapid breathing, and chills, occurring in at least 5% of patients.

Ebola virus disease (EVD), caused by Orthoebolavirus zairense, is a severe and often deadly condition with fatality rates ranging from 25% to 90%. It is transmitted through bodily fluids, zoonotic transmission, or contact with contaminated surfaces. The U.S. Department of Homeland Security has identified EVD as a significant threat to national health security. To bolster response capabilities, BARDA is focused on the advanced development, licensure, and procurement of therapeutics for outbreak deployment.

Emergent BioSolutions is dedicated to protecting and enhancing life. For 25 years, they have been preparing to defend against various public health threats. They offer solutions through a portfolio of vaccines and therapeutics, developed and manufactured for governments and consumers. Emergent also provides integrated contract development and manufacturing services for pharmaceutical and biotechnology clients.