Eli Lilly may have deep-sixed trials of its COVID-19 antibody treatment in hospitalized patients for lack of efficacy, but that’s not stopping the U.S. government from placing a huge bet on the drug’s success in other settings.
The government struck a $375 million deal with the company for 300,000 vials of the antibody treatment, bamlanivimab (LY-CoV555), provided it wins an emergency use authorization from the FDA, Lilly announced Wednesday. The pact includes an option for the government to pick up 650,000 additional vials as well as a guarantee patients will face no out-of-pocket expenses for the drug.
The government deal was a welcome piece of good news for a drug that has seen its fair share of setbacks. Despite mixed data in patients with mild to moderate disease—only one of three doses tested appeared to work—Lilly applied to the FDA for emergency use authorization of bamlanivimab in early October.
Then came news that the National Institutes of Health (NIH) paused the phase 3 study of the drug in hospitalized patients, after an independent data safety monitoring board saw initial data. Soon after, reports emerged that the FDA might crack down on Lilly for manufacturing issues at a New Jersey plant that’s making the drug.
Finally, yesterday, the NIH scrapped the trial of bamlanivimab in hospitalized patients, citing “a low likelihood that the intervention would be of clinical value” in that population. The data safety monitoring board recommended that step after reviewing data on 326 participants in the trial.
During a conference call with analysts following Lilly’s third-quarter earnings release yesterday, the company’s chief scientific officer, Dan Skovronsky, M.D., Ph.D., said data showed adding bamlanivimab to Gilead Sciences' FDA-approved COVID-19 treatment Veklury (remdesivir) and other treatments “is unlikely to further help hospitalized COVID-19 patients recover” from advanced COVID-19.
But Lilly remains confident bamlanivimab will prove its worth in other COVID-19 patients, including those with mild to moderate symptoms who face a high risk of progressing to more serious disease. Skovronsky cited data from the trial that tested three different doses in 452 patients with mild to moderate symptoms. One of the three doses tested prevented progression of the disease, Lilly said.
“While the results in hospitalized patients were disappointing, we don't expect this to affect our chances of success in prophylaxis or in early treatment,” Skovronsky said. Pooled data from studies of the drug both as a monotherapy and in combination with other treatments “showed a reduction of hospitalizations and ER visits of greater than 75% across all patients,” he said.
Lilly CEO David Ricks said he isn't worried the manufacturing issues will hamper bamlanivimab, either. In response to the FDA's concerns, he said during the conference call, Lilly hired an independent firm to review its manufacturing practices and is "working diligently to incorporate suggestions for improvement to our procedures."
But even if bamlanivimab is authorized by the FDA, Lilly will be well behind Regeneron, which scored a $450 million supply deal with the U.S. government back in July. Regeneron started ramping up its manufacturing effort so it can produce up to 300,000 doses for treatment and a whopping 1.3 million for prevention.
Lilly could use a COVID-19 boost. With its diabetes blockbuster Trulicity under pressure, the company’s executives lowered their earnings-per-share guidance for the full year Tuesday. They maintained an earlier revenue forecast of $23.7 billion to $24.2 billion—but conceded that to hit the high end of that range, there would need to be a contribution from COVID-19 treatments.