Novartis CEO: We are moving towards filing Covid drugs with molecular partners with the FDA

Below is the unofficial transcript of an exclusive CNBC interview with Novartis (NYSE:NVS) CEO Dr. Vas Narasimhan on CNBC’s “Squawk on the Street” (MF 9AM – 11AM ET) today. , Wednesday 12 Januaryand. Here is a link to the video on CNBC.com:

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Novartis CEO: We are moving towards filing Covid drugs with molecular partners with the FDA

CARL QUINTANILLA: Day three of the JPMorgan Healthcare conference. Meg Tirrell joins us with a special guest. Hi Meg.

MEG TIRRELL: Hi Carl. Joining us now is Dr. Vas Narasimhan, CEO of Novartis. Come on, it’s great to see you. Thanks to be here. You know, I want to start with the news you had this week about a potential COVID drug that you licensed from Molecular Partners. The data looks really good, somewhat similar to antibody drugs. How quickly do you think this might be able to go through regulators and get to patients?

DR. VAS NARASIMHAN: Yes, thank you Meg. Great to be here as always with you. This drug ensovibep is quite exciting. It’s a new technology called DARPin. It is an engineered anchor and repeat protein that can target the COVID spike protein to three different locations. And what that allows this drug to do in all the in vitro tests that we’ve done so far is be able to neutralize all the COVID virus strains of concern quite consistently. Now, this is the first data we have clinically showing that the drug is able to reduce viral load, speed up recovery time and reduce hospitalizations and deaths by 79%. So right now, we’re moving towards filing with the FDA for emergency use authorization. Our goal is to increase manufacturing to start having supplies in the first half of this year with more scale for the second half of this year. And the real vision here is to have a drug that can be used, hopefully, regardless of the strain of COVID that might mutate in the future.

TIRRELL: And I understand that because of the way this drug is made, you might be able to make it faster in larger quantities, what kinds of doses do you expect in terms of the number of courses that might be available?

NARASIMHAN: You know, it’s a unique manufacturing process compared to antibodies. So rather than using mammalian cells, it uses bacterial production which allows us to increase the production of bacterial cells, which allows us to scale production faster to much larger volumes, also has higher yields. I think it’s too early to say exactly how much we could produce this year but we certainly think we’ll be in the millions of doses and over a million doses and really now the question is how fast can we tell us that. Again, assuming we get regulatory approvals and any other necessary support from the US government as well as other governments, but we’re certainly doing everything we can to ramp up manufacturing as quickly as possible.

TIRRELL: And I understand Novartis is also working on an oral pan-coronavirus drug, which may be in clinical trials this year. Just tell us how you view COVID and what solutions will be needed for the future? It doesn’t sound like you think this is something we’re going to get over soon.

NARASIMHAN: Well, we have certainly learned that pandemics are likely to be with us in one form or another and certainly coronaviruses. And the idea here is that one of the critical proteins for a coronavirus that is independent of the type of coronavirus is called the main protease and our hope is that by designing a drug for this main protease inhibitor it would be effective regardless the strain of coronavirus that may come in the future. So whether it’s SARS, MERS, COVID, anything else down the line, we’ve been working on this for about 18 months. We have identified a development candidate. We’re working now to bring that into the clinic and then hopefully we’ll have data over the next year, years, I would say, to really get something out of it, but it would give us an option to future pandemics. And I think with the first ensovibep drug like this, we’re trying to take a longer-term view to bring solutions to the world.

TIRRELL: Well, a longer term view is something that I think a lot of people would appreciate, especially as we see what’s happening with testing right now. I also want to ask you about some other news of the day, namely the Centers for Medicare & Medicaid Services coverage decision on amyloid antibody drugs for Alzheimer’s disease. You know, I wanted to ask you about this because you and I talked after Biogen got this fast-track approval in June and you noted, okay, there’s this pathway, maybe for drugs in neurology and maybe that’s something everyone in the industry should be looking at. Does CMS’s strict coverage decision change the opportunity you think you’ve seen from the FDA in neurology?

NARASIMHAN: Well, I think we have a unique set of circumstances here, which people who have been in the industry for a long time certainly haven’t really seen before, where you have a set of trials that weren’t always going in the same direction and some data a little difficult to interpret. I think what this indicates is that even in neuroscience we need strong studies that demonstrate not only a biomarker benefit but also a clinical benefit for patients, for payers to want to cover, cover a medication. I think it also highlights the challenge we face that there are times when the regulator has one point of view and then the reimbursement bodies have a different point of view. This is a problem we have faced in Europe for many years. In general, we would be in favor of regulators and reimbursement bodies trying to align their views. I think that’s a pretty unique circumstance in terms of data and of course now CMS output.

TIRRELL: All right, Go, we have to leave it at that. But we’d love to see you again because there’s a lot more to talk about with Sandoz, the proceeds of your Roche stake sale, so much more Vas, thanks for being with us.

NARASIMHAN: Thank you Meg.

Updated

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