Emergent BioSolutions will manufacture, sell, and distribute Ebanga (ansuvimab) in the US and Canada through its partnership with Ridgeback Biotherapeutics.
The deal, of which financial details have not been divulged, sees Emergent and Ridgeback Bio collaborate to expand the availability of Ebanga, which was approved by the US Food and Drug Administration (FDA) in December 2020
Image: Stock Photo Secrets
December 2020 to treat Ebola.
Ebanga was developed to treat Ebola by Ridgeback Bio under license from the National Institute of Allergy and Infectious Diseases and is a monoclonal antibody (mAb) that has antiviral activity, administered through a single injection.
“It is a complex manufacturing process that requires some time to complete. It is necessary to have manufactured and stockpiled Ebanga in advance of an outbreak or public health emergency – not after one has been declared,” a spokesperson for Emergent told us.
Additionally, Ridgeback Bio provided funding and support for and during clinical testing and extra funding came from contracts with the Biomedical Advanced Research and Development Authority (BARDA) for late-stage production and regulatory activities to guarantee that all requirements for FDA approval were completed.
“This relationship with Ridgeback Bio builds on our strategic focus and deep expertise in developing and supplying medical countermeasures against serious health threats,” said Robert Kramer, CEO of Emergent.
“Ebanga is crucial in the ongoing fight to contain Ebola and we are excited about the future of this collaboration to create a healthier, more secure world.”
Emergent has not disclosed where it will manufacture Ebanga but the firm has faced issues at its Bayview facility. The Maryland facility was hit with a Form 483 in in April 2021 due to an ingredient mix up reported in March 2021, which rendered 15 million doses unusable, and the firm decided to halt production at the facility.