The US government will play Eli Lilly & Co more than $1 billion in exchange for about one million doses of its experimental coronavirus antibody treatment.
It’s the latest move by the Trump administration as it stocks up on vaccine and drugs in an attempt to tame the pandemic that has killed more than 225,00 Americans.
Lilly will start delivering 300,000 doses of the antibody, LY-CoV55, also known as bamlanivimab, for which it is being paid $375 million, if it receives Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
The price per dose amounts to $1,250 as per the contract, but the vials purchased by the government will be free to the American public.
The news come after the drugmaker ended its clinical trial of the antibody and remdesivir after the National Institutes of Health found the combination failed to help recovery of hospitalized patients.
The US government will play Eli Lilly & Co $375 million in exchange for 300,000 doses of its experimental coronavirus antibody treatment. Pictured: An Eli Lilly researcher tests possible COVID-19 antibodies in a laboratory in Indianapolis, May 2020
Earlier this month, Lilly applied for emergency use with the FDA for the antibody as treatment for mildly and moderately ill COVID-19 patients. Pictured: The headquarters of Eli Lilly & Co stands in Indianapolis, June 2010
The initial agreement is for Lilly to deliver the doses over the two months following an EUA
It also provides the option for the government to buy an additional 650,000 vials for $812.5 million, the US Department of Health and Human Services said in a statement.
‘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,’ said CEO David Ricks said in a statement.
‘Supply agreements with governments – such as this one with the US government to meet Operation Warp Speed goals – are fundamental to enable the most widespread and equitable access to our potential therapy.’
The US has also signed deals with AstraZeneca and Regeneron Pharmaceuticals for their antibody therapies, under Trump administration’s Operation Warp Speed program.
The deal with Regeneron covers the cost of manufacturing, while the deal with AstraZeneca also includes support for development.
While vaccines are seen critical to ending the pandemic, governments are increasingly looking at other effective treatments to slow the spread of the virus and kick-start economic activity.
Recently, Lilly filed a request for FDA approval to treat mild to moderately ill COVID-19 patients after promising results from a study.
Researchers found that hospitalization or ER visits occurred in 1.7 percent of 302 patients given the drug and six percent of those given the placebo, a 72 percent risk reduction.
No serious side effects or deaths were reported among patients.
The antibody therapy is similar to a drug from Regeneron 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.
Recently, Lilly was forced to end its clinical trial of an antibody drug early after it was shown to not help hospitalized coronavirus patients recover.
The ACTIV-3 study was paused on October 13 due to ‘potential safety concerns’ and out of an ‘abundance of caution.’
However, company officials have still not revealed what the safety concerns were, or how many hospitalized participants were affected, after a pause was recommended by an independent safety board.
In a statement on Monday, the National Institutes of Health (NIH), which was sponsoring the trial, said the antibody treatment did not pose any safety risk.
However, investigators found that there was no significant difference in outcomes between patients getting Lilly’s drug and those receiving a placebo.
The antibody therapy is similar to a drug from Regeneron 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.
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 drug had a recent setback after it failed to show benefits in hospitalized patients.
In addition, Reuters reported that U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly plant that is ramping up to make its antibody therapy.
The antibody therapy is similar to a drug from Regeneron 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.3
Source: Daily Mail
