Eli Lilly and Company (Lilly) has signed a $375 million deal with the US government for the supply of 300,000 vials of bamlanivimab (LY-CoV555) 700mg, an investigational neutralizing antibody for the treatment of Covid-19.
LY-CoV555 is the first antibody candidate to come out from Lilly’s collaboration with AbCellera Biologics, which was announced in March this year. The collaboration’s objective is to develop antibody therapies for the prevention as well as treatment of the novel coronavirus.
According to Lilly, the US government will accept the vials of the neutralizing antibody if it secures an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Earlier this month, the US pharma giant had filed a request to the FDA seeking an EUA for the use of bamlanivimab in mild to moderate Covid-19 in high-risk patients.
The initial agreement between Lilly and the US government is for delivery of the neutralizing antibody over the two months after an EUA. It also offers the option for the federal government to buy up to an additional 650,000 vials till 30 June 2021, under the same terms as the initial agreement.
The deal will be subject to agreement from Lilly, availability of the product, and also the medical requirement in the country.
David A. Ricks – Lilly chairman and CEO said: “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.
“The U.S. is experiencing a surge in COVID-19 cases and associated hospitalizations, and we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”
Lilly expects to manufacture up to a million doses of bamlanivimab 700 mg by the end of this year, with 100,000 doses ready to be dispatched within days of authorization for use across the world.
Bamlanivimab is a neutralizing IgG1 monoclonal antibody (mAb) that is directed against the spike protein of SARS-CoV-2, the virus that causes Covid-19.
Lilly had wrapped up a phase 1 study of bamlanivimab in hospitalized Covid-19 patients.
A phase 2 study in those who were diagnosed recently with Covid-19 in the ambulatory setting is going on.
On the other hand, a phase 3 study of bamlanivimab to study its ability in the prevention of Covid-19 is going on in residents and staff at long-term care facilities.
Additionally, bamlanivimab is being evaluated in the US National Institutes of Health-led ACTIV-2 study of ambulatory Covid-19 patients.