BARDA slows its $9B engine for new Covid-19 therapeutics
The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.
An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”
The announcement arrives at a surprising time because Congress just recently passed a law pulling together more than $6 billion for HHS to spend on research, development, manufacturing, production, and the purchase of vaccines, therapeutics, and ancillary medical products and supplies. Nicholas Florko at STAT News first reported the shift by BARDA.
Why the decision is coming now remains unknown, although selecting treatments that actually prove to be safe and effective can be a very difficult task. Of those 13 therapeutics BARDA has put money into so far, four have now failed to materialize or had its EUA revoked.
Merck’s checkpoint inhibitor failed to get off the ground as the FDA told Merck that additional data, beyond a study conducted by subsidiary OncoImmune, would be needed to support a potential EUA application. BARDA spent more than $355 million on developing the Merck drug, while two other repurposed drugs from Regeneron (Sarilumab, which received about $70 million) and Roche’s Genentech (Actemra, which received $25 million) failed in trials.
Eli Lilly’s bamlanivimab had its EUA revoked on April 16, but bamlanivimab is still available as part of a combo treatment that BARDA paid $210 million to purchase doses of.
BARDA also found success with the more than $3 billion it invested in Regeneron’s monoclonal antibody cocktail of casirivimab and imdevimab.
Other projects are ongoing. Sab Biotherapeutics has received more than $100 million to test its novel polyclonal antibody, which NIH is helping to study in a Phase 2/3 trial for non-hospitalized people with mild or moderate cases of COVID-19.
BARDA also awarded more than $15 million to help Emergent BioSolutions, made famous for its Baltimore manufacturing plant fiasco, to develop human immune globulin, which is derived from plasma donated by those who have recovered from Covid-19.