Following is the unofficial transcript of a CNBC interview with Regeneron Pharmaceuticals Inc (NASDAQ:REGN) Co-Founder & CEO Dr. Leonard Schleifer on CNBC’s “Squawk Box” (M-F, 6AM-9AM ET) today, Thursday, December 16th. Following is a link to video on CNBC.com:
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Regeneron CEO: We’ll Need Covid Antibodies To Work Against Omicron If It Surges
MEG TIRRELL: Becky, thanks so much. Regeneron just a few moments ago saying its antibody drug used to treat patients with COVID loses potency against the Omicron variant. Dr. Len Schleifer is the CEO of Regeneron joins us now live to discuss. Len, thanks for being with us this morning. I think modeling data had suggested this and a lot of folks expected it but now you are confirming it with the lab data. Of course, your antibody drug does hold up against Delta, which is now the circulating variant but how concerning are these results? Does it mean if Omicron becomes dominant in certain areas, your drugs should no longer be used?
DR. LEONARD SCHLEIFER: Yeah, well so, there's a couple of important things to remember about how we approach all this. First of all, I have to remind everybody, vaccinate, vaccinate, vaccinate, boost, boost, boost. It's still the best way to get things, get people protected and wear masks, socially distant. Thursday night poker game if you're playing one, give it up for a while. We're in the midst of a surge. Now, our antibody cocktail that works against Delta. Delta is still surging and so we want to direct that therapy to people who have Delta. But if Omicron starts to surge, we need antibodies that work against Omicron and by the way, I think you covered it on the news very well the other night, Meg, that it's possible that Delta will surge, the flu will surge and so will Omicron. So we're going to need a full, full toolkit here and we're excited to say this morning that we actually have a whole host of new antibodies which can work against both Omicron and Delta. So while the current cocktail doesn't, this sort of emphasizes the need to play the long game here. We've got new antibodies now that we've tested and they work against both Delta and Omicron. We hope to get in the clinic very early next year with those. We're going to work with the FDA. And by the way, I should say, people think that healthcare workers, the doctors, the nurses, the scientists at the companies and academia, we owe a debt of gratitude to the FDA. They're killing themselves looking at every sort of thing. And so, we're looking forward to hopefully working with them and trying to get the next generation as efficiently as possible because it has to play an important role in our toolkit against COVID.
TIRRELL: Right, and I want to ask you about what you think that regulatory process might look like. But before we go there, as you mentioned, there is a philosophy now that we might see Omicron and Delta cocirculating, in which case, we need to figure out which one folks have to decide if they should get your antibody drug. Is it possible to do that quickly enough to be able to administer the antibodies, you know, either using PCR tests that have that S-gene target failure marker or can there be rapid genome sequencing to determine the variant somebody has?
DR. SCHLEIFER: Yeah, Meg, it’s a really important point, you know, if you think about when you have an antibiotic infection and you go to the hospital, we don't just randomly guess. We actually can test whether the antibiotic that's chosen matches up against the bacteria that you've got. I think we're gonna have to be in that in the virus business. The technology is there. It's not quite where I think where everybody would like us to be in terms of scale, speed, point of care and so forth but I really could see a world where we may have more than one variant circulating and we're gonna need to pick and choose our weapons depending upon which one that you have. We don't need new technology for this. We just have to figure out how to get that out a little bit more efficiently, get it to a point of care, get it so it turns around rapidly. We can distinguish technologically between Omicron and Delta and anything else that might come along.
TIRRELL: Of course you’ve said these next generation, oh go ahead Becky.
BECKY QUICK: I think you were gonna ask the question about the FDA on this first, go ahead.
TIRRELL: Well, thanks and I am wondering, Len, how quickly do you think these new next generation antibodies could get through the regulatory process? Does it require big clinical trials to show efficacy again or can there be some pathway that's creative like we've seen for the vaccines?
DR. SCHLEIFER: Yeah, I think that we're hoping and we made a proposal just recently to the FDA that we can use some sort of pathway that looks a little bit like the vaccines. If you have a validated platform that can select the antibodies, that you can test the antibodies, that can scale the antibodies and you can do this safely in terms of your, your manufacturing processes. I think we need to figure out a way that we can get this to patients on a large scale before the next variant shows up and we just, we don't want to be chasing our tail here. So, we look forward to working with the agency and trying to figure out efficient ways but safe ways, that's always the tension. You don't want to go too fast but you don't want to go so slow as you don't do any good. We think our platforms have sort of proven themselves time and time again. And that's why we like to think of being in this for the long haul. You know that Omicron is not the last letter in the Greek alphabet and I would say that the, we have to have a scheme that allows us to deal with them as they come up efficiently but safely.
QUICK: Hey Len, I wanted to ask you about just the use of monoclonal antibodies in that patient population who is immunocompromised, at risk. We've talked about this a lot. You've been advocating and have been before the FDA asking to be able to give those patients use of monoclonal antibodies as a preventative measure, not just if they are actually already exposed to COVID or have COVID. The FDA did give approval for AstraZeneca to do just that a week ago. Do you know anything more about your request for that or if that would be approved at some point?
DR. SCHLEIFER: Yeah, well, we don't, we never know if it will be approved. We hope and we know the FDA is committed to looking at it and we're interacting with them and we'll respond to any questions that they may have. I think that, you know, a lot of this gets superseded by what is going to be out there. The concept of prevention with a monoclonal antibody makes great sense. In reality, you got to make sure that you're matching what you're giving somebody against what is out there and maybe you're going to have to have more than one preventative as this, just like you might need more than one vaccine as the variants start to emerge and new ones come. I mean, this is, this was a pretty scary mutation. If you think about it, we used to see evolution this virus sort of step by step. This was leap by leap, giant leap from the Delta, which had troublesome mutations in it. So, all of a sudden, something that had 30 or 40 and you mentioned the immunocompromised, there's a fair degree of reasonable scientific speculation that the Omicron emerged because it percolated in an immunocompromised individual and that's why we believe it's so important to protect the immunocompromised from being infected with a variant that their body can't do. We have some interesting data coming out, which I can't quite talk about yet, which I think suggests in the real world immune compromised people can be helped with antibodies but you gotta, I know you talked about, I know you're worried, I don't want to get into your personal family, but I know you mentioned on the air about your mom, I hope she's doing well and you can tell her we're certainly working hard and I know the agency, the FDA is working hard also to try and figure out the best way to deal with—
QUICK: Yeah, it's not just my mom, it's, you know, the millions of people who are out there and in the same position.
DR. SCHLEIFER: No, no, I, kudos to you, Becky. I know that we we've talked about that. You're not doing this just for your mom. There's a whole 10 million people out there and this is something that we all want to address and we are working hard. The FDA did authorize the first prevention that was great with AstraZeneca’s product, good for them there. We'd like to have one also, none of us can make enough to supply the entire need here. So yeah, we're working at this.
ANDREW ROSS SORKIN: Well Len, that's what I wanted to ask you about. But I also want to ask you about the trajectory of this particular variant which is to say, given how it transmits and how quickly and efficiently unfortunately it seems to do that, and maybe it will turn out to be fortunate, is it possible that we do have a wave, the wave effectively crests and by the time you're able to either come up with a or have this, this new drug available or frankly even whether Pfizer is actually produce enough of their own pills that we're already going to be on to the next and how we should even think about that?
DR. SCHLEIFER: Andrew, you know, you, you've asked the question that I can guarantee you a lot of smart people in industry and government and academia trying to wrestle with. We're not used to our whole approach, in terms of all those groups I just mentioned, we're not used to dealing with things on such a rapid scale. We're developing a drug for, you know, let's say one of our drugs for macular degeneration, EYLEA, or our DUPIXENT drug for some allergic diseases such as really bad eczema. You know, you don't have that same emergency and once you get it, the disease isn't changing. These infectious diseases are changing like you're suggesting at such speed that we need whole new regulatory schema to deal with them and the old conservative do no harm way has to be rethought because the greater harm might be that we do nothing so we have to weigh these things. I know people are thinking about this very carefully. But in the meanwhile, by the way, I got to say, mark, socially distance, get your booster. There are, there are measures that you can take right now that will help us but we do have to go faster and figure this out.
TIRRELL: An important message, Len Schleifer, we really appreciate you being here with us this morning and helping us untangle all this new information. Thanks again.
DR. SCHLEIFER: Thanks, Meg. Thanks, everybody.
