Trump administration agrees to purchase $375 million of Lilly coronavirus antibody drug

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.

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U.S. signs deal with Lilly for supply of potential COVID-19 antibody drug

FILE PHOTO: Eli Lilly logo is shown on one of the company’s offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake

(Reuters) – The U.S. Government has awarded an initial $375 million contract to drugmaker Eli Lilly and Co LLY.N to secure 300,000 doses of its potential experimental COVID-19 antibody treatment, a drug that has been touted by U.S. President Donald Trump.

Lilly will start delivering the treatment within two months of receiving an emergency use authorization from the U.S. health regulator, the company said.

The U.S. government also has the option to purchase up to an additional 650,000 vials for $812.5 million, the U.S. Department of Health and Human Services said in a statement.

While vaccines are seen critical to ending the pandemic, governments are increasingly looking at effective treatment options to slow the spread of the disease and kick-start economic activity.

The company submitted a request to the U.S. Food and Drug Administration earlier this month for emergency use authorization of the drug to treat mild to moderate COVID-19 patients.

The U.S. government has committed that patients will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product’s administration, Lilly said.

The antibody therapy is similar to a drug from Regeneron Pharmaceuticals REGN.O that was given to Trump during his bout with COVID-19.

The treatments belong to a class of drugs called monoclonal antibodies that are manufactured copies of antibodies created by the body to fight against an infection. Lilly’s antibody was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty

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Lilly Stops Antibody Trial in Hospitalized COVID-19 Patients

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and rheumatology. Follow Damian on Twitter:  @MedReporter.

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