Eli Lilly and Company has signed an agreement with the US Government to deliver up to 600,000 doses of its investigational drug, bebtelovimab (LY-CoV1404; LY3853113), for at least $720m.
A neutralising IgG1 monoclonal antibody (mAb), bebtelovimab is directed against the SARS-CoV-2 virus’ spike protein.
Bebtelovimab was discovered by AbCellera and the US National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center researchers while Lilly licensed and developed it.
It is claimed to have binding and neutralising activity against various SARS-CoV-2 variants of concern, including Omicron and BA.2, in pseudovirus and authentic virus testing.
The drug is being analysed to treat mild-to-moderate Covid-19 both as a single agent and in combination with other mAbs.
Lilly has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for bebtelovimab to treat mild-to-moderate Covid-19 in specific high-risk patients.
According to the agreement, the drug doses will be delivered by 31 March with an option to deliver additional 500,000 doses before 31 July.
They will be accepted by the US Government upon the FDA granting a EUA to bebtelovimab.
In January, the FDA revised the authorisations of Eli Lilly and Regeneron Pharmaceuticals’ two monoclonal antibody therapies to limit their usage.
The revised authorisation for Lilly’s bamlanivimab plus etesevimab and Regeneron’s REGEN-COV (casirivimab and imdevimab) comes after data demonstrated that the therapies are very unlikely to be active against Omicron.
The FDA had noted that these antibody therapies are limited to only if a patient is infected by or exposed to the variant.