Eli Lilly Strikes Deal with Govt Over COVID-19 Antibody Drug

October 30, 2020 - HHS and the Department of Defense (DoD) recently announced an agreement with Eli Lilly and Company to purchase the first doses of the company’s COVID-19 antibody therapeutic, LY-CoV555.

The initiative is part of the Trump Administration’s goal of delivering life-saving vaccines and therapeutics through Operation Warp Speed (OWS).

OWS is a program that was developed in May 2020. HHS designed the program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics, between components of HHS. 

The doses of LY-CoV555 will become available for patient care if FDA authorizes use of the therapeutic, following the agency guidance. 

The government-purchased doses of the antibody would also become available to US citizens at no cost, per the agreement with Eli Lilly. But HHS noted that healthcare professionals could charge for administering the medicine.

“This agreement with Eli Lilly is part of Operation Warp Speed’s efforts to position the federal government to distribute potential therapeutics, allowing faster distribution if trials are successful,” HHS Secretary Alex Azar said in the announcement. 

“More good news about COVID-19 therapeutics is constantly emerging, and the Trump Administration’s commitment to supporting potentially lifesaving therapeutics will help deliver these products to American patients without a day’s delay,” Azar added.

The Biomedical Advanced Research and Development Authority (BARDA) also collaborated with the DoD joint program executive office for chemical, biological, radiological, and nuclear defense and army contracting command.

Together, the organizations granted $375 million for an initial purchase of 300,000 doses of LY-CoV555 from Eli Lilly. Additionally, the federal government can purchase up to 650,000 additional doses through the end of June 2021 for up to $812.5 million.

Eli Lilly and Company anticipates manufacturing up to one million doses of LY-CoV555 by the end of the year, with 100,000 doses ready to ship after authorization for use globally, according to a press release.

"Lilly has leveraged our deep scientific capability to fight this pandemic and we are proud of our efforts to develop potential medicines to combat COVID-19. Supply agreements with governments – such as this one with the U.S. government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy," David A. Ricks, Lilly's chairman and CEO, said in the press release. 

Currently, the antibody is being evaluated in Phase 3 clinical trials funded by the company in addition to other clinical trials as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a partnership led by the National Institutes of Health (NIH).

ACTIV is part of a coordinated research strategy to boost development of the most promising treatments and vaccines. At the beginning of this week, Eli Lilly released a statement regarding NIH’s ACTIV-3 clinical trial.

The company said that based on an updated dataset from the trial, no additional COVID-19 patients will receive LY-CoV555. 

This recommendation was based on trial data suggesting that the antibody was unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease.

But all other studies of LY-CoV555 remain ongoing, including ACTIV-2, BLAZE-1, and BLAZE-2. 

At the beginning of August, the company launched the Phase 3 BLAZE-2 trial tostudy a single dose of LY-CoV555 in residents and staff at nursing facilities across the US.

The study enrolled nearly 2,500 participants from facilities that have had a recently diagnosed case of COVID-19 and are at a high risk of exposure.

It will uncover if the antibody reduces the rate of COVID-19 over four weeks and complications of the virus through eight weeks. 

However, based on data from BLAZE-1, Eli Lilly recently submitted a request for FDA emergency use authorization for the antibody drug. The request from early October that that drug is intended for the treatment of COVID-19 in high-risk patients.