Eli Lilly and Company and the Bill & Melinda Gates Foundation, as part of the COVID-19 Therapeutics Accelerator, have entered into an agreement to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus, to benefit low- and middle-income countries.
Therapeutic antibodies have the potential to prevent and treat COVID-19, reducing the burden on healthcare systems worldwide. This effort to bring equitable access to novel treatments is part of the COVID-19 Therapeutics Accelerator, an initiative launched by the Gates Foundation, Wellcome, and Mastercard to speed the development of and access to therapies for COVID-19.
Commercial manufacturing will commence in April 2021 at the FUJIFILM Diosynth Biotechnologies facility in Denmark, where the Therapeutics Accelerator reserved manufacturing capacity in an agreement announced in April. The Gates Foundation based its decision to collaborate with Lilly for the manufacturing capacity on pre-set criteria, including available information regarding safety, efficacy and ability to implement in lower-resource settings.
Lilly has already started the manufacturing technology transfer at risk, in anticipation of regulatory authorization for its antibody therapy. In the interest of making supply of COVID-19 therapeutic innovations available globally as quickly as possible, Lilly will make certain volumes of its antibody therapeutic manufactured in other facilities available to lower-income countries prior to April 2021, pending the timing of regulatory authorization. Lilly and its collaboration partners will continue to be responsible for research and development of the product.
Lilly's collaborators, AbCellera Biologics Inc., Shanghai Junshi Biosciences Co., Ltd. and Columbia University have agreed to waive their royalties on the Lilly therapeutic antibodies distributed in low- and middle-income countries as part of this initiative.
"Medicines that can help reduce the impact of COVID-19 will be an important part of the solution to this pandemic and are urgently needed by people all over the world," said David A. Ricks, Lilly's chairman and CEO. "Lilly is proud to be a part of the collective global effort to help ensure equitable access to COVID-19 therapeutic options for people in low- and middle-income countries."
The arrangement is part of Lilly's philanthropic efforts and supports Lilly 30x30, the company's goal to improve access to quality health care for 30 million people living in settings with limited resources, each year, by 2030. This latest effort builds on decades of public-private-philanthropic partnerships among Lilly and other biopharmaceutical industry partners. This includes collaborations on tuberculosis and more recent agreements to speed the development, manufacture and delivery of vaccines, diagnostics and treatments for COVID-19, as well as a health worker training initiative that will reach up to 1.7 million people in six sub-Saharan African countries.
"To help end the COVID-19 pandemic it is vital that people, no matter where they live or their ability to pay, can access effective therapeutics," said Mark Suzman, CEO of the Bill & Melinda Gates Foundation. "It is encouraging to see Lilly stepping up and committing to making products more affordable and accessible to everyone who needs them. Until every country can effectively tackle COVID-19, no country will be safe."
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer term.