"Lilly and its collaborators have partnered closely with the federal government throughout the pandemic to ensure broad and equitable access to our monoclonal antibodies," said David A. Ricks, Lilly's chair and CEO. "While Congress works toward additional COVID-19 funding, Lilly and the U.S. government will continue to work together to support the availability of bebtelovimab to maximize equity and accessibility in the U.S. market."
Delivery of doses will begin immediately and complete no later than August 5, 2022. The 2022 estimated financial impact of this agreement is approximately $275 million of revenue and approximately $0.08 of EPS. An option for an additional 350,000 doses to be exercised no later than September 14, 2022 will remain in the agreement.
This purchase has been supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number W58P0522C0012.
Important Information about bebtelovimabBebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The emergency use of bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab.
About bebtelovimabBebtelovimab (LY-CoV1404; LY3853113) is a neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 that maintains binding and neutralizing activity across currently known and reported variants of concern. Bebtelovimab has been studied for the treatment of mild-to-moderate COVID-19 both as a monotherapy and together with other mAbs. Lilly has licensed and developed bebtelovimab after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center.
About BLAZE-4BLAZE-4 is a Phase 2, randomized clinical trial evaluating treatment of subjects with mild-to-moderate COVID-19 (subjects with COVID-19 symptoms who are not hospitalized). The data supporting this EUA for treatment of mild-to-moderate COVID-19 are primarily based on analyses of data from the Phase 2 BLAZE-4 trial (NCT04634409), treatment arms 9-14. This trial evaluated the clinical safety and efficacy from subjects receiving 175 mg bebtelovimab, alone and together with 700 mg bamlanivimab and 1,400 mg of etesevimab. The authorized dosage of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. Clinical data confirm the neutralizing ability of bebtelovimab. The trial enrolled subjects who were not hospitalized and had 1 or more COVID-19 symptoms that were at least mild in severity.
About Lilly's COVID-19 EffortsLilly has utilized the full force of its expertise to develop the first monoclonal antibody authorized for Emergency Use (EUA) by the U.S. Food and Drug Administration (FDA) – bamlanivimab, followed by the authorization of bamlanivimab with etesevimab and, most recently, bebtelovimab. The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds.
While bamlanivimab together with etesevimab are not authorized for use in the U.S., at this time, the FDA will monitor conditions to determine whether use in a geographic region is medically appropriate, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
To date, over 700,000 patients have been treated with Lilly's monoclonal antibodies in the U.S., potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths during the worst of the pandemic.
About Eli Lilly and CompanyLilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.