The Trump administration will pay Eli Lilly $375 million to supply 300,000 doses of its experimental antibody drug to treat COVID-19, the Department of Health and Human Services said Wednesday.
If the Food and Drug Administration authorizes use of the drug, the federal government will allocate the doses to state and territorial health departments which, in turn, will determine which health care facilities receive the drug for use in outpatient care.
Eli Lilly said it anticipates only high-risk patients will be indicated to receive the drug until more studies are completed and more supply is available.
The initial agreement is for delivery over the course of two months following authorization, with the option to purchase up to 650,000 additional doses through the end of June 2021 for up to an additional $812.5 million.
The government-purchased doses would become available to Americans at no cost, although health care professionals could charge for administering the medicine.
Eli Lilly’s CEO, David Ricks, said the company is allocating the drugs to the countries that need them most and will commit only to a few months of supply at a time to any given country in order to match demand with the limited supply.
“Unfortunately, the U.S. now leads the world in both COVID-19 cases and deaths. As a result, a top priority is helping reduce disease burden in the U.S.,” Ricks said.
The rolling seven-day average of daily cases in the U.S. topped 70,000, according to COVID Tracking Project data. With that many cases a day, the projected supply of the monoclonal antibodies would not be nearly sufficient to meet demand.
Eli Lilly said it anticipates manufacturing up to 1 million doses of its drug by the end of 2020, with 100,000 doses ready to ship within days of authorization.
The agreement with Eli Lilly is part of the administration’s Operation Warp Speed, the initiative created by the administration to fund the quick development and distribution of a COVID-19 vaccine.
Ricks said Eli Lilly is pricing the drug at $1,250 per vial in wealthy countries, with a tiered system based on the country’s ability to pay. One vial represents the full course of treatment.
Ricks said the company expects to make a profit and is pricing the drug “above our marginal cost to produce the medicine in developed markets,” meaning it expects “to produce a modest financial return for our investors by the end of 2021.”
The announcement of the agreement comes a day after Eli Lilly said the drug had no clinical benefit for helping hospitalized patients. The company said it is confident the drug is helpful to those earlier in the course of a COVID-19 infection.
Antibody drugs are experimental, and while doctors think they are promising as a potential treatment of COVID-19 and could be a bridge to a vaccine, clinical studies are still ongoing.
But President Trump has created confusion by quickly elevating them to a cure.
After he was diagnosed with COVID-19 and hospitalized, Trump said he received an antibody cocktail from Regeneron and touted it as a “miracle” and a “cure.”
There’s no evidence Regeneron’s antibody therapy was responsible for Trump’s apparent recovery.