/CNW/ - Eli Lilly Canada announced today that Lilly and the Government of Canada have signed an agreement for the supply of bamlanivimab to Canada. Lilly will...
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Lilly and the Government of Canada sign an agreement for the supply of bamlanivimab to treat COVID-19 in Canada
Bamlanivimab is a SARS-CoV-2-neutralizing antibody that emerged from the collaboration between Lilly and Vancouver-based AbCellera
TORONTO, Nov. 24, 2020 /CNW/ - Eli Lilly Canada announced today that Lilly and the Government of Canada have signed an agreement for the supply of bamlanivimab to Canada. Lilly will supply Canada with an initial quantity of 26,000 doses of bamlanivimab over the three-month period between December 2020 and February 2021, for US$32.5 million. Lilly is taking a data-driven approach to the worldwide allocation of bamlanivimab according to our
guiding principles that prioritize countries according to their medical need. Additional doses will be supplied to Canada on a monthly basis according to the medical need in Canada and the availability of supply.
The Government of Canada will be working with provincial and territorial partners to equitably allocate supply, while recognizing the need for flexibility based on COVID-19 activity across the country.
Bamlanivimab received authorization for its use as a treatment of adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization on November 20, 2020 under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
"From the beginning of our collaboration with AbCellera in March, through the interim authorization for the use of bamlanivimab in November, to an agreement on supply just days later, Lilly is bringing the full force of our expertise to meeting the challenge of COVID-19 in Canada, and around the world," said Rhonda Pacheco, President and General Manager, Lilly Canada. "We're grateful to the Government of Canada for their collaboration in working to quickly make this medicine available for Canadians."
About bamlanivimab
Bamlanivimab is a recombinant, neutralizing human 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 treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (
NCT04411628). A Phase 2 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1,
NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2,
NCT04497987) is also ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.
About BLAZE-1
BLAZE-1 (
NCT04427501) is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of bamlanivimab alone or in combination with a second antibody for the treatment of symptomatic COVID-19 in the outpatient setting. To be eligible, patients were required to have mild or moderate symptoms of COVID-19 as well as a positive SARS-CoV-2 test based on a sample collected no more than three days prior to drug infusion.
The monotherapy arms of the trial enrolled mild to moderate recently diagnosed COVID-19 patients, studying three doses of bamlanivimab (700 mg, 2800 mg, and 7000 mg) versus placebo. The primary outcome measure for the completed arms of the BLAZE-1 trial was change from baseline to day 11 in SARS-CoV-2 viral load. Additional endpoints include the percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.
The study is ongoing with additional treatment arms. Across all treatment arms, the trial will enroll over 800 participants.
Data from the monotherapy arms of BLAZE-1 were published in the
New England Journal of Medicine.