Eli Lilly and Company announced a Joint Procurement Agreement with the European Commission (EC) to supply up to 220,000 doses of bamlanivimab and etesevimab for the treatment of confirmed COVID-19 in patients aged 12 years and older who do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19. This agreement helps to provide access to treatments by enabling participating countries in the European Union (EU) and European Economic Area (EEA) to purchase the products directly from Lilly, following national approval for emergency use, or marketing authorization at the EU level. Quantities purchased may vary based on local needs as determined by participating countries.
This action follows the scientific opinion under Article 5(3) of Regulation 726/2004 issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in March supporting the use of these antibodies as a treatment for COVID-19 in patients aged 12 and older. The CHMP scientific opinion supports national decision-making within EU member states on the use of treatments before a formal marketing authorization is granted, during a public health emergency.
"Bamlanivimab and etesevimab have played an important role in the fight against COVID-19, helping hundreds of thousands of patients globally," said Alfonso Zulueta, senior vice president and president, Lilly International. "Lilly is pleased to have reached this agreement with the European Commission which opens the door for many European countries to access this life-saving treatment option for patients with COVID-19."
Preclinical data from our labs have demonstrated that bamlanivimab and etesevimab administered together retain neutralization activity against variants currently in circulation in many countries, including Delta and Alpha. Based on the high transmissibility of the Delta variant, currently over 95 percent of new COVID-19 infections in the EU/EEA have been identified as being caused by the Delta variant.
Bamlanivimab administered with etesevimab is available under emergency pathways in 15 countries around the world for the treatment of COVID-19.
While a number of European countries have previously ordered bamlanivimab and etesevimab from Lilly in the first half of the year, and have inventory on hand, this agreement provides access to additional doses for participating countries, should they be needed. Lilly does not anticipate an impact to 2021 guidance as a result of this agreement.
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