Eli Lilly lines up a blockbuster deal for Covid-19 antibody, right after it failed a NIAID trial
Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.
The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.
The government is lining up delivery of the 700 mg dose of the drug, even though the one study Eli Lilly points to for proof of efficacy underscores the drug — obtained from AbCellera — did not work at that dose for recently diagnosed patients. Only the 2800 mg dose was effective for the primary endpoint, change from baseline in viral load at day 11, with the low and high doses falling short of significance — though even that is a questionable assumption.
A number of analysts remarked that Lilly’s data were middling at best, with no dose dependent response to help make Lilly’s case. But Lilly said the data were close enough, and used that lower dose, which they can make more of, for their EUA application.
Lilly added that it has the manufacturing in place to make a million doses of the drug by the end of 2021, with supplies ramping up for global delivery in Q1. The first 100,000 vials should be good to go almost immediately after the FDA acts, says the company, though the pharma giant has also been cited by regulators for quality problems with the manufacturing facility that makes the antibody.
An EUA is still a strong likelihood, even after the NIAID just shuttered a study testing the drug in hospitalized patients. Researchers ruled out a safety issue, leaving the door open to an emergency authorization for a drug that has been touted by President Trump. Lilly quickly followed up the trial failure with a statement that researchers still believe it works among less severely afflicted patients — though the case for that is based on their BLAZE-1 study, where the 700 mg dose was ineffective.
Lilly CEO David Ricks noted that “we believe bamlanivimab could be an important therapeutic option that can bring value to the overall healthcare system, as it has shown a potential benefit in clinical outcomes with a reduction in viral load and rates of symptoms and hospitalizations.”