WHEN: Today, Tuesday, November 30, 2021
WHERE: CNBC's "Squawk Box"
Following is the unofficial transcript of a CNBC interview with Regeneron Pharmaceuticals Co-Founder & CEO Dr. Leonard Schleifer on CNBC's "Squawk Box" (M-F, 6AM-9AM ET) today, Tuesday, November 30th. Following is a link to video on CNBC.com: https://www.cnbc.com/video/2021/11/30/regeneron-ceo-well-likely-have-to-constantly-adapt-our-antibody-cocktail.html.
All references must be sourced to CNBC.
JOE KERNEN: And Andrew, Len Schleifer, a MD and a PhD sent me a, an article from the New England Journal of Medicine, which he says is really important to put all this in context, and I can't wait to talk about it and he's here. Regeneron is down today because probably not surprisingly, the drug cocktail, the antibody cocktail is not as effective against the variant. Eli Lilly seeing some similar data, probably. Len Schleifer, it's great to have you on, Founder, President CEO of Regeneron. If the vaccines aren't going to work as well because they generate antibodies that aren't specific to Omicron, it's not surprising that the monoclonal antibodies don't work as well either. So, this is, this is what we would expect.
DR. LEONARD SCHLEIFER: Yeah, well, first, thanks for having me on. Joe. I really like being on your show with you and Becky, Andrew, Cramer and especially Meg Tirrell. You guys have realized that if we're going to inform the public, we have to have it based in science. We can't have wild speculations out there. We really have to focus on what we know and what we can know and get to real data. So far Omicron looks like it is a great concern. One has to step back and think about how did we get this Omicron. It didn't just slowly mutate it looks like. To me and to many other scientists, it looks like this is a case where it evolved in a single immunocompromised individual because if you look at that paper actually you're referring to in the New England Journal, right, it explains how that can happen.
KERNEN: Yeah, 152 days the patient had it and that was the point I was going to make Len that we seem to think that if, if COVID is multiplying and all these unvaccinated people that you're going to get these random mutations. What, what this says to me is that you put it in one single incubator of an immunocompromised person and you get multiple variations in that person because the immune system doesn't, doesn't get rid of the virus. So,156 days that happens in one person which makes me think Len, we need to treat immunocompromised people with antibodies to get rid of it. It won't help as much just to vaccinate. If it's not, if the variants aren't coming from unvaccinated people, but immunocompromised people, we need therapeutics to make sure that we don't let something fester for 156 days.
SCHLEIFER: Joe, you're spot on. We have to deal. Some people like to say this is man against virus, but in some respects it's mankind against virus. We're all sort of one organism and if we have a weak link in the chain because some people unfortunately are having chemotherapy or or you know that in the Gauteng province in South Africa, the incidence of HIV infection is about 20%. So, it's not a surprise that in that immunocompromised population that variants are emerging and they're emerging by leapfrog kind of a mutation, not slow evolution. And this is gonna keep going until we deal with treating everybody including the immunocompromised. We have five to 10 million immunocompromised people in the United States, and we have to deal with that population or we'll have the same problem here. It won't be Omicron. It'll be the next letter in the Greek alphabet.
KERNEN: So we need, that's why I said we could, we could be immunizing and vaccinating people but immunocompromised people, they don't have the immune system to respond to it. So, we need to ramp up efforts for therapeutics. So how quickly can you or Lilly or somebody else customize a monoclonal antibody to a variant? How quickly can we get that rolling?
SCHLEIFER: Well, so we've been having it rolling for a couple years. Now remember, we designed our cocktail trying to anticipate the changes. We anticipated the changes that Delta would give and our cocktail was very effective against Delta. You should remind your viewers, we should all remind our viewers that the monoclonal antibodies that are out there now and are authorized for their indications for the virus that circulate in the US works just fine, so we shouldn't abandon that. But we have to anticipate the next one. And Omicron is a difficult one to anticipate. We've actually thought about a lot of, a lot of even most of the variations that could occur in Omicron and we have another antibody that looks promising that's already started clinical testing, but we have probably the largest collection of antibodies in the world. We think we're going to be in this for a long, long time. Just like vaccines are going to have to adapt, we're probably going to constantly have to adapt our monoclonals and we have a large repertoire of them and then we're going to have to keep cycling them, Joe.
BECKY QUICK: Hey Len, it sounds like science and you guys at Regeneron and so many other companies are on top of all of this. You're keeping up with every change as it comes, you're giving us a great amount of hope. I'm not sure that the regulatory authorities are quite there with you yet though. You know, I have someone I love who has cancer right now who's an active cancer patient, gone through chemo and radiation and when I heard from you last time when you came on the show and talked about this, I thought how great and fantastic this is. She's gonna be able to get back out there. But these antibodies are not approved for cancer patients or immunocompromised people to be taking proactively. It's only approved if you are, you know, exposed to it or get it and only some of the doctors are even prescribing it when you've been exposed. Some of the cancer centers are doing that right now. When is the FDA gonna say it's okay to use this proactively for people who the vaccines wouldn't necessarily help. This would be the answer instead of a vaccine to make sure that they don't get it in the first place and that they can get back out there and live their lives.
SCHLEIFER: Becky, you, you've made the speech that we have made to the agency, and we're in constant contact with them. We've had a request down there for nearly six months or maybe a little over. We've updated with our recent data that suggests for the current circulating viruses. our cocktail can be given infrequently, perhaps once every three months or even once every five months and offer a passive vaccine for your friend and the millions of people like her as opposed—
QUICK: It's my mother.
SCHLEIFER: As opposed to giving an active vaccine, which they don't respond to.
QUICK: So, what's the solution? I mean, I think Scott Gottlieb and others say we should be doing this right now. What's the solution and people are dying needlessly?
SCHLEIFER: Yeah. Look, I suspect and I don't know that there's been a sort of a maniacal focus on vaccines in anything that distracts or tells people that there's some treatment might discourage people from taking vaccines. That's the only explanation that I can come up with. We are anxious to continue to work with the FDA. They are the ones who are in authority. We have to work with them. We will work with them. We've worked with them for 30 years, but we admit we are baffled on this one.
ANDREW ROSS SORKIN: Doctor, at the beginning of the interview when you were talking with Joe, you said that you were, you had great concern about this new variant and I know we're still in speculation mode because all the data is not back yet but I know that you've been studying this and I'm curious how concerned you are both in terms of transmissibility, in terms of disease, in terms of the danger that it really poses because I think that there's a lot of folks right now that are hoping for the best, hoping it's mild or hoping it's less, it's not as transmissible or it's similarly transmissible. So, what do we actually know? What do you think you know?
SCHLEIFER: Yeah, so it'd be a little bit irresponsible for me to speculate on some of the things that I'm not really an expert on, transmissibility, how sick it makes people. You know there are epidemiologists who are looking at this almost by the minute, looking at the tracking the rate of spread, and the data is going to emerge over the next month. So, it probably doesn't help but what we can speculate on because it's based on some data is that, you know, some of the common vaccines that are out there, unlikely to take a hit, our cocktail, certainly one of the antibodies should take a hit, the other one, maybe less so. We've started with very potent antibodies so we don't, we have to look at how much the hit is but more importantly, we have to get ready for the next one and we have to come up with a regulatory schema, if you will, so that when we have to change the vaccine or we have to change the antibody, that we can do it in a way that doesn't isn't irresponsible and take unnecessary risk, but doesn't force us to wait so long is that by the time we get it approved, there is already a different one. We need to work together with the regulatory authorities and I'm sure they're thinking hard about this. How do we make these substitutions in as an efficient way as possible? When do we switch over our manufacturing to the next one? What's the timing going to be? So many unanswered questions.
KERNEN: Len, sorry to interrupt. We got a lot of, not much time left. We got a lot riding on the Pfizer and Merck therapeutics too. You messaged, you corresponded with me about maybe some data that's, that's not so great, maybe on the Merck therapeutic. What can you tell us?
SCHLEIFER: Yeah, well, I mean, look, when they first presented the data, there was a 50% effect size. When they presented the other half of the study the overall effect size went down to 30%. And what that really means in the second half of the study, there was no effect. So you did the study sort of once and then you did it where it had a small effect and then the second time where it had no effect. To me, that would be of great concern on the efficacy side. On the safety side, we still have to deal with the genotoxicity and the mute, the ability to mutate the virus and frankly, cells in the people who get it. So, I think this is, is difficult. Pfizer looks a little more promising. It's got some issues with drug, drug interactions, but those seem more manageable. I'm anxious to see their full data package and see the FDA's review of it. And so, I'm hopeful that that will be a little bit better in terms of an oral. But in terms of chronic prevention, monoclonal antibodies given infrequently, given their efficacy and their safety and millions of people have taken them, I think that's the way to go. All we have to do is to make sure we stay ahead of the variants with the right amount of monoclonal cocktail.
KERNEN: Well Regeneron, you're in the monoclonal business obviously, and I'm not saying that that will cause you to talk your book but the point you made about the immunocompromised people being individual incubators for these hideous variants is a good one because it means that's a market we need to address, a problem we need to address and you can only address that, you can't address that with a vaccine. You got to address that with, with a therapeutic and in this case, a monoclonal maybe.
SCHLEIFER: Absolutely, Joe. It's just staggering that we, we have 10 million incubators out there. It's going to happen in this country. We're going to get these super variants emerging and it may look, it could make Omicron obsolete pretty quickly. We have to address this issue.
KERNEN: Well thank you for getting an MD and a PhD.
SCHLEIFER: My parents were proud.
KERNEN: It's a lot of work and a lot of years in school but we're grateful to have you on today. Thank you.
SCHLEIFER: Thanks Joe.