Lilly announces 650,000 additional doses of neutralizing antibody bamlanivimab (LY-CoV555) purchased by U.S. government to treat COVID-19
INDIANAPOLIS, Dec. 2, 2020 /PRNewswire/ -- The U.S. government has purchased 650,000 additional doses of Eli Lilly and Company's (NYSE: LLY) neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The purchase agreement is for $812.5 million and the doses will be delivered through January 31, 2021, with at least 350,000 of the additional doses delivered in December 2020. Bamlanivimab recently received emergency use authorization for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
"Given the significant increase in COVID-19 cases and hospitalizations in the U.S., we are doing everything possible to quickly provide more bamlanivimab doses to Americans," said David A. Ricks, Lilly's chairman and CEO. "We are proud of our work to deploy significant manufacturing capacity and remain committed to enabling widespread and equitable access to bamlanivimab. The U.S. government's effort to allocate bamlanivimab around the country is critical to ensuring it reaches patients who need it the most."
This purchase brings the total doses purchased by the U.S. government to 950,000. As previously announced by the U.S. government, Americans 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 is responsible for the allocation of bamlanivimab. Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data from the U.S. Department of Health and Human Services' Protect data collection platform. Weekly allocations can be viewed at this online federal dashboard. State and territorial health departments determine which sites of care receive the allocated doses.
Lilly has a robust, global supply chain in place to produce bamlanivimab, with numerous manufacturing sites worldwide. Lilly continues to manufacture bamlanivimab for use around the world, and the supply is expected to increase substantially in 2021. Global allocations will be made based on Lilly's guiding principles, which aim to ensure access for patients with high unmet need, no matter where they live.
In 2020, the estimated impact of the updated purchase agreement to the guidance range provided in Lilly's earnings release on October 27, 2020 is approximately $500 million of additional revenue and approximately 25 cents of additional earnings per share.
Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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 Lilly's COVID-19 Efforts
Lilly 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.
December 2, 2020
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