- Eli Lilly, Fujifilm Diosynth Biotechnologies and the Bill & Melinda Gates Foundation are teaming up to bring a potential COVID-19 treatment to low- and middle-income countries.
- FujiFilm will manufacture Lilly's coronavirus antibody drug at a plant in Denmark, where it had already reserved capacity as part of the COVID-19 Therapeutics Accelerator effort. Commercial manufacturing is slated to start in April 2021.
- Lilly plans to offer supplies of the therapy from other manufacturing facilities before April 2021, depending on regulatory clearances, according to its Oct. 8 statement. Its collaborators — AbCellera Biologics, Shanghai Junshi Biosciences and Columbia University — are waiving their royalties for product that goes to low- and middle-income nations.
The agreement is another example of the pace set by drugmakers as they race to confront the COVID-19 pandemic. Lilly said it's already begun transferring manufacturing technology at risk, before regulators have declared that the treatment is safe and effective and ready for use.
Lilly's antibody treatment is similar to another one from Regeneron, which received attention after doctors gave it to President Trump earlier this month. Both Lilly and Regeneron have asked the FDA for emergency clearance for their products.
Both treatments are still in clinical testing, with only early data to suggest the drugs might be beneficial. And recent developments for Lilly illustrate the complicated path that may lie ahead, as the company faces both regulatory headaches and the normal bumps in the road that go with clinical research.
This week, Reuters reported that FDA inspectors found "serious quality control problems" at a Lilly plant in Branchburg, New Jersey, that is gearing up to manufacture the COVID-19 treatment. The company told Reuters it has launched a "comprehensive remediation plan" to address the FDA's concerns.
Meanwhile, U.S. government researchers paused a large study of Lilly's antibody treatment in combination with Gilead's Veklury in hospitalized patients because an independent monitoring board recommended initiating a safety review. Lilly said no other trial had been stopped, and the company's application for emergency approval is based on a different study in recently diagnosed patients with more mild disease.
Such pauses in research aren't unusual and show that the system is working as it should. In this case, however, the news is magnified by the great need for a treatment to counteract the epidemic.
Even without further complications, Lilly and Regeneron face a daunting task in trying to meet the demand that will likely result if their FDA applications are approved. Regeneron has said it can produce about 300,000 doses by the end of this year, and Lilly has previously promised about 1 million doses.
The new coronavirus has so far infected almost 39 million people around the world.