The US government will take the delivery of bamlanivimab vials after it achieves an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA), said Eli Lilly.
Earlier this month, the company filed an application with the FDA for EUA status for bamlanivimab to treat mild to moderate Covid-19 in high-risk patients. Under an initial agreement, Eli Lilly will deliver 300,000 vials over the two months following a EUA status.
The agreement also enables the US government to purchase up to an additional 650,000 vials through 30 June 2021 under the similar terms as the base agreement and subject to agreement from Lilly, product availability and the medical requirement in the US.
Bamlanivimab is a potent and neutralising IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2.
The investigational antibody has been designed to restrict viral attachment and entry into human cells, thereby helping to neutralise the virus, potentially prevent and treat Covid-19.
Bamlanivimab is a result of the collaboration between Lilly and AbCellera. Lilly said that it has already completed a phase 1 study of bamlanivimab in hospitalised patients with Covid-19.
A phase 2 study is ongoing in people recently diagnosed with Covid-19 in the ambulatory setting, as well as a phase 3 study is also undergoing to prevent Covid-19 in residents and staff at long-term care facilities.
Lilly chairman and CEO David Ricks said: “Lilly has leveraged our deep scientific capability to fight this pandemic and we are proud of our efforts to develop potential medicines to combat Covid-19.
“Supply agreements with governments – such as this one with the U.S. government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy.”
Earlier this month, Eli Lilly agreed to acquire privately-held biotechnology company Disarm Therapeutics for an upfront payment of $135m.