Was it a blessing or a curse for Eli Lilly & Co. that President Donald Trump was treated with coronavirus antibodies made by rival Regeneron Pharmaceuticals Inc.?
Neither, according to David Ricks, Lilly’s chief executive officer. What Trump’s treatment did was underscore the critical role of antiviral therapies in combating a disease that, far from being eradicated by new vaccines, is likely to become “endemic,” challenging the public-health system for years to come, Ricks said in an interview for the HLTH virtual conference.
Following is a transcript of Ricks’s remarks, lightly edited for length and clarity. Since the interview was recorded on Oct. 6, Lilly has sought an emergency use authorization for its antibody therapy from the U.S. Food and Drug Administration. Subsequently, the company said it has paused enrollment of participants in a trial of the treatment over an unspecified safety concern.
Erik Schatzker: For months, vaccines have been getting all the attention, and by some estimates, 10 times as much federal funding. Why so much focus on vaccines and not on therapies?
David Ricks: We need both, of course. There are many challenges with the vaccine process — producing enough, ensuring safety, public education, etc. They’ve allocated $10 billion. That is a very small sum compared to the economic impact. So I think it’s a wise investment by itself. You could ask, “Why don’t we spend more on therapeutics as well?” And I think that would be the right thing to do, because the best vaccines early won’t protect more than 50% or 60% of those who receive them. That’s the FDA standard. And not everyone will choose to be vaccinated, so this disease will become endemic and will continue to spread. Medicines like monoclonal antibodies could help prevent the worst parts of this illness.
ES: Would you like federal funding, or is Lilly better off not having received money from the government?
DR: Well, we’ve chosen not to receive any money. We’re well capitalized and have lots of cash flow. We also are one of the largest manufacturers of monoclonal antibodies in the world already, so by rearranging our capacities and then forming new partnerships we could create quite a bit of capacity. We’ve done that. We hope that these get reimbursed, that developed markets pay for the therapy so that we can cover our cost of research and manufacturing. That’s what we’re in discussions with many governments about now.
ES: In just six months Lilly was able to generate clinical data that proved antibodies can neutralize the virus. How were you able to compress the timeline so dramatically?
DR: We made a decision to start commercial stage production in April before we had even dosed a human with the drug. That is very unusual in our industry and usually doesn’t start until you’ve proved something really works.
ES: Has your company, and perhaps the government as well, learned things over the course of this pandemic that will change the game for drug development and treatment development?
DR: One thing that really has worked is being much less bureaucratic and regimented about regulatory interactions and really working as a team to move a medicine to patients. I hope elements of that will persist into other therapy areas. The world needs an Alzheimer’s medicine. We need new antibiotics. We need better drugs for diabetes and other serious conditions like cancer.
ES: How much faster might you be able to develop new drugs or new treatments in the future?
DR: We’ve learned how we could do this even quicker the next time by not having a cold start, but an ever-warm effort across the industry. That would be very helpful for future pandemic preparedness. We could shave at least two months off the time to a commercial-scale product if we had done a few things differently. Recruitment to clinical studies is a vexing problem across all therapy areas. It takes more time than you can imagine to find the right subjects to get in the right study. And during a pandemic, that’s been challenging. I think many people want to do their part to progress the science but just don’t know how to.
ES: President Trump received the Regeneron antibodies and not the Lilly antibodies. Is that a curse or a blessing?
DR: It’s done one important thing, which is raise the discussion about antibodies and their importance, particularly for people with high-risk co-morbidities — age, weight, hypertension, diabetes, etc. That’s the right place to use this kind of medicine. We’re not competing with Regeneron. There are more patients than there is supply, so there really aren’t enough competitors to really solve the pandemic. Together we can make an important dent in the disease.
ES: Have you experienced a surge in requests for compassionate use?
DR: We’re beginning to experience that now, and we’re setting up a facility to manage that better. We know health disparities in this country are a major issue. Emergency use authorization by the FDA is really the way to address that.
ES: What is Lilly’s timeline for FDA emergency use authorization?
DR: Days or weeks. We want to be sure it’s safe and effective and the right precautions are taken around it.
ES: What is Lilly’s capacity for manufacturing right now and how ambitiously can you expand it?
DR: We’ve done quite a bit at unprecedented speed to make sure we can bring as much volume to the fight as we could.
ES: The U.S. clearly wants to secure as much as possible of viable vaccines and viable treatments for the coronavirus. How do you balance the demands of your country against the needs of the world?
DR: We have strong views on this. We think it should be matched closely to where the disease outbreak is occurring, not based on national borders or the ability to pay. We’re not running an auction to the highest bidder. Our pricing will be indexed to gross national income per capita so that the ability to pay will be based on a country’s wealth, not other factors. If the disease is mainly in poor countries, we’ll probably lose money. But it will a lot of problems and save some lives that wouldn’t have been saved otherwise. If it’s all in rich countries, so be it.
ES: At the moment, all of these antibody treatments are still experimental, and they require intravenous infusion in a clinical setting. In the future, do you think it’ll be possible to get an antibody shot from your doctor or perhaps even the local pharmacy?
DR: I do think that’s possible, and we’re actively working on that problem. An infusion is faster and, given the shortage of material, it’s a way to get the antibodies in your body with the least amount of waste. But there are two other strategies we’re pursuing. One is subcutaneous, where you could self-administer with a shot in your belly or your rear end. To get to there, we’ll need to have very potent antibodies. The other strategy is called IV push. You get a line in your arm, much like you’re giving blood, and rather than take out blood, you push in medicine. That’s a very quick, nurse-administered process that can be done outside of a hospital setting.
ES: The public has been led to believe that not only is a vaccine coming but it will quickly produce herd immunity on a global scale. Is that realistic, or are we going to be living with some form of the coronavirus for years to come?
DR: Probably the latter, unfortunately. It would be surprising to have a highly effective vaccine on the first go. We’re using relatively new technology for these early vaccines. Most of them require two shots. The other big factor is many people may choose not to be vaccinated, and that’s a tragedy. We need something much closer to 100%. We need media, social media and trusted authorities to help people understand why it’s in everyone’s interest to become vaccinated. In that gap between ideal and what will happen, we have medicines. That’s why we’re working on the antibodies.
ES: What lessons about the health-care system, good or bad, should we draw from the Covid-19 experience?
DR: We can move faster. Do I have confidence that everyone in this country gets the same care? No. Income, knowing where to go versus not where to go, and even differences between doctors, has borne out in unnecessary mortality and morbidity.
ES: Will the public’s image of drug companies change as a result of the scientific triumphs in the fight against the coronavirus?
DR: That’s incumbent on two things: One, us finding better ways to simply explain what we do. We make things very complicated, and that’s been a challenge for us. Two, discovering more cures for diseases that take people’s lives. This year in the U.S., Covid will be the third-most-common reason someone dies. More people die of cardiovascular disease and cancer. One thing we all have learned is without our health we don’t have much.
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