Lilly, US Gov’t Form $375-M Supply Pact for COVID-19 mAb Candidate
Eli Lilly and Company has entered into an agreement for $375 million with the US government to supply 300,000 vials of LY-CoV555 (bamlanivimab) (700 mg), the company’s investigational monoclonal antibody for treating COVID-19.
The supply agreement is conditioned on bamlanivimab receiving an emergency use authorization (EUA) by the US Food and Drug Administration (FDA). Lilly submitted a request for an EUA for bamlanivimab for treating mild-to-moderate COVID-19 in high-risk patients to the FDA in early October (October 2020). The agreement with the US government is for delivery of 300,000 vials of bamlanivimab over two months following an EUA. It also provides the option for the US government to purchase up to an additional 650,000 vials through June 30, 2021, under the same terms as the base agreement and subject to agreement from Lilly, product availability, and the medical need in the US.
Lilly says it anticipates manufacturing up to one million doses of bamlanivimab (700 mg) by the end of 2020, with 100,000 doses ready to be shipped within days of authorization, for use globally. The company says supply of is expected to increase beginning in the first quarter of 2021 as additional manufacturing resources come on line throughout the year (2020).
If an EUA is granted, Lilly says the US 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 US federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab. Lilly is partnering with Operation Warp Speed, a US government initiative to speed the development of COVID-19 vaccines and treatments, and a national distributor to finalize distribution plans and shipping preparations, should an EUA be granted. Lilly is also working with Operation Warp Speed to assist US 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.
Bamlanivimab is the lead candidate from Lilly’s collaboration with AbCellera, a Vancouver, British Columbia, Canada-based biopharmaceutical company, which Lilly formed earlier this year (2020). It is a neutralizing antibody against SARS-CoV-2, the virus that causes COVID-19. It is designed to block viral attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19, according to information from Lilly.
Bamlanivimab is also being studied in several ongoing studies: (1) a Phase II study in people recently diagnosed with COVID-19 in the ambulatory setting; (2) a Phase III study of bamlanivimab for preventing COVID-19 in residents and staff at long-term care facilities; and (3) a National Institutes of Health (NIH)-led study of ambulatory COVID-19 patients.
Earlier this week (October 26, 2020), the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, decided to stop enrollment of a NIH-study evaluating bamlanivimab for treating hospitalized COVID-19 patients. The NIAID’s decision was based on a recommendation from an independent data safety monitoring board.
Source: Eli Lilly and Company (supply pact), Eli Lilly and Company (clinical studies), and the National Institute of Allergy and Infectious Diseases