In a mere nine months, Eli Lilly & Co. accomplished an unprecedented feat: The drug giant took a blood sample from one of the first U.S. patients to recover from COVID-19, identified an antibody that could fight the virus, and created a version of the antibody in the lab to treat people around the world who have contracted the deadly disease.
On Monday, the therapy Lilly developed with Canadian biotech AbCellera Biologics Inc. won emergency-use authorization from U.S. drug regulators to treat COVID-19, widening access to a treatment that early data suggest is effective in keeping people infected with the coronavirus out of the hospital. Anthony Fauci, the top U.S. infectious-disease official, has referred to antibody-based medicines as a bridge to a vaccine. And with a global surge in cases, high demand for the treatment is virtually guaranteed.
Bloomberg spoke to Chief Executive Officer David Ricks in his first interview after Lilly was granted a green-light from U.S. regulators about the challenges facing the company and its new treatment amid the worsening pandemic. Here is an excerpt:
Bloomberg: Your company is among the first to develop a monoclonal antibody to treat COVID-19 and to receive emergency-use authorization from U.S. regulators. What does this mean for treating those who have become infected with the virus?
Ricks: It’s an incredible feat of science over a disease. And we’re not done. We’re working on improved versions and getting a full license for this. We’d like to get it approved in Europe and other countries. With today’s news on Pfizer’s vaccine, plus this, now we have an exit strategy.
Bloomberg: What do you see as the greatest challenge ahead?
Ricks: The real challenge is about scale. I don’t think we would have predicted back in April when we triggered the decision to start manufacturing at a pretty big scale — million of doses this fall — that we may need all of those. And now we’re in the middle of this surge. We’re going to run out of supply. The FDA has given a little broader latitude, they’ve narrowed in on the high risk population. And I think that’s a good thing. But that’s against the background of probably something like a million patients diagnosed with COVID-19 this week in the United States, and among those, we would estimate some 30% are high risk. So there’s not enough supply to go around.
Bloomberg: How quickly do you anticipate the first batches of vials might make their way to patients?
Ricks: We’re loading the trucks right now. So, as fast as trucks can move. We’ve made 88,000 doses that are being loaded tonight, and we should have another, about that much, inside of a week, shipping out to centers across the country.
Bloomberg: What should one do if they think they fall into the camp of a high-risk individual who is at the early-stages of COVID-19? Can they try to get access to your monoclonal antibody?
Ricks: We need to confirm that they have the disease and they have symptoms. Speed is important here. The sooner you have some of the signature symptoms and the sooner you get test results, the sooner you’ll be a candidate for the medicine. And then patients should ask their doctor if they’re a candidate. The physician will decide if this is a good use for that patient. Within days this should be able to happen coast to coast.
Bloomberg: If the drug also proves an effective preventative measure in a separate study, won’t that further constrain supplies?
Ricks: That’s the great problem. There’s a four or five months lag time in the decision to when you can have products. So the products we have now, we made the decision to start manufacturing July 1st. Since then we brought on a major international partner in Samsung and Amgen, which has a huge capacity as well. Those would be coming in the winter time. And we’ve also used a couple of Lilly’s sites, as well as partnering with the Gates Foundation on using the Fujifilm site in Denmark so that this can be available in the poorest countries. We’ve got all that lined up and are interested in more, of course. But the other strategy here would be to seek lower and lower doses so we could stretch this material even farther.
Bloomberg: You’ve clinched a novel agreement with the U.S. for supply of 300,000 vials with the option to buy another 650,000, but only if Lilly decides the need is greatest in the U.S., and not elsewhere in the world. What was your thinking in arriving at those terms?
Ricks: At the time we signed that deal, we were interested in making sure that there was access to this medicine, no matter where the disease was. Of course, Europe has an approved drug and they haven’t contracted with us yet. So while that’s the case, I think our ability to get more drugs to the U.S. will go up. But both parties — Lilly and the U.S. — need to agree. If Europe approves this quickly and wants to contract again at the same rates as the U.S. we’ll ship product to them as well. There’s an epidemic, particularly in France right now, that’s very concerning. We want to get the product to where it’s needed.
Bloomberg: How will working with a new Biden administration change the outlook for supply and distribution in the U.S.?
Ricks: They announced their Covid task force, and many of those are people we know well and have been in institutions related to health-care issues for a very long time, including David Kessler, the former FDA commissioner. So I expect no change, to be honest. The Warp Speed effort works really well. And, I think they know that and want to keep it working well. I know they’ll be good partners.