Eli Lilly and Co. entered an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million, pending Emergency Use Authorization by the FDA. Lilly submitted a request for an EUA for bamlanivimab for the treatment of mild to moderate COVID-19 in high-risk patients to the FDA in early October. The initial agreement is for delivery over the two months following an EUA and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021.

If an EUA is granted, the U.S. government has committed that patients will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration. The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab. As part of this government program, Lilly is partnering with Operation Warp Speed and a national distributor to finalize distribution plans and shipping preparations, should an EUA be granted.

The intravenous administration of therapeutics to patients with confirmed mild to moderate COVID-19 presents unique challenges to the healthcare system. Lilly is also working closely with Operation Warp Speed to assist U.S. federal and state agencies in the identification and creation of options for locations where patients can receive this medication that are accessible and minimize infection transmission.

Lilly anticipates manufacturing up to one million doses of bamlanivimab 700 mg by the end of 2020 – with 100,000 doses ready to ship within days of authorization – for use around the world. The supply of Lilly’s antibody therapy is expected to increase substantially beginning in 1Q21, as additional manufacturing resources come online throughout the year.

Lilly has a robust, global supply chain in place to produce bamlanivimab, with five active pharmaceutical ingredients (API) manufacturing sites worldwide. To ensure rapid access of this treatment to patients around the world, Lilly has invested in large-scale manufacturing of bamlanivimab at risk, before data demonstrated its potential to become a meaningful therapeutic option for COVID-19.

Bamlanivimab is a potent, neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.