Lilly Announces Arrangement for Supply of Potential COVID-19 Antibody Therapy for Low- and Middle-Income Countries
Eli Lilly and Company (NYSE: LLY) has partnered with the Bill & Melinda Gates Foundation to improve access to its COVID-19 therapeutic antibodies in low- and middle-income countries. The initiative, part of the COVID-19 Therapeutics Accelerator, aims to facilitate the distribution of these treatments around the world. Manufacturing is set to begin in April 2021, with some volumes available earlier, pending regulatory approval. Collaborators of Lilly have waived their royalties for these therapies in the targeted regions, reinforcing the commitment to equitable healthcare access.
- Collaboration with the Bill & Melinda Gates Foundation to enhance access to COVID-19 antibodies.
- Manufacturing set to commence in April 2021, increasing potential supply to low-income countries.
- Royalty waivers from collaborators, facilitating access to antibodies in low-resource settings.
- Regulatory approvals for the therapeutic antibodies are still pending, which may delay availability.
- Substantial risks and uncertainties in the drug development process remain.
INDIANAPOLIS, Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 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."
About the COVID-19 Therapeutics Accelerator
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. For more information, visit www.therapeuticsaccelerator.org
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 now 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 here for media resources related to Lilly's COVID-19 efforts.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news. C-LLY
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 an agreement between Lilly and The Bill & Melinda Gates Foundation to facilitate access to future Lilly therapeutic antibodies under development for the prevention and treatment of COVID-19 to low- and middle-income countries, 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 that Lilly's therapeutic antibodies under development will prove to be safe and effective treatments or preventatives for COVID-19, that Lilly will receive regulatory approvals or authorizations, or that we can provide an adequate supply of such treatments or preventatives to low- and middle-income countries 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.
Refer to: | Molly McCully; mccully_molly@lilly.com; (317) 478-5423 (Media) |
Kevin Hern; hern_kevin_r@lilly.com; (317) 277-1838 (Investors) |
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