StemCell Therapy

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 principlesthat 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 bamlanivimabBamlanivimab 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 bamlanivimabin 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-1BLAZE-1 (NCT04427501) is arandomized, 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.

About Lilly's COVID-19 EffortsLilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click herefor resources related to Lilly's COVID-19 efforts.

About Lilly CanadaEli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at http://www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on twitter @LillyPadCA

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, as well as its supply, and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization.Among other things, there can be no guarantee thatfuture study results will be consistent with the results to date, that bamlanivimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab will receive regulatory approvals or additional authorizations, or that we can provide an adequate supply of bamlanivimab in all circumstances.For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

SOURCE Eli Lilly Canada Inc.

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Lilly and the Government of Canada sign an agreement for the supply of bamlanivimab to treat COVID-19 in Canada - Benzinga

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