The Biomedical Advanced Research and Development Authority (BARDA) has reached an agreement with Regeneron Pharmaceuticals to procure Ebola virus treatment as part of the U.S. Department of Health and Human Services’ (HHS) effort to prepare for public health emergencies.
The treatment, known as REGN-EB3, is Regeneron’s investigational triple antibody cocktail treatment for the Ebola virus infection. It is currently under Priority Review by the U.S. Food and Drug Administration (FDA), with a target action date of Oct. 25.
Pending FDA approval, Regeneron expects to deliver an established number of treatment doses over the course of six years. It would receive compensation of approximately $10 million in 2021 and an average of $67 million per year for each of the next five years through 2026.
“Developed using Regeneron’s proprietary VelociSuite rapid response technologies, REGN-EB3 was shown to save lives in the PALM trial, which evaluated multiple therapies against the previous standard of care for Ebola,” Leonard Schleifer, co-founder, president, and CEO of Regeneron, said. “Regeneron’s thirty years of investment in our technology and people enabled the development of REGN-EB3, which reinforces the importance of having at-the-ready tools to fight emerging pathogens. As we push through the current COVID-19 pandemic, it’s important for governments and industry to ensure preparedness for the next global health crisis by continuing to invest in innovative science and broad manufacturing capacity.”
A clinical trial conducted in the Democratic Republic of the Congo in 2019 showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm. REGN-EB3 demonstrated superior efficacy across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.
“The current COVID-19 pandemic provides an important lesson in preparation for potential biological threats to our nation’s health security,” BARDA acting director Gary Disbrow, said. “REGN-EB3 is the result of years of collaboration, which demonstrates the fundamental value of public-private partnership in protecting Americans from global epidemics. Whether the next one is another coronavirus, an Ebola virus or a completely novel disease, we must do everything we can to be prepared.”