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Novartis CEO: We’re Moving Toward Filing Covid Drug From Molecular Partners With FDA

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Following is the unofficial transcript of a CNBC exclusive interview with Novartis (NYSE:NVS) CEO Dr. Vas Narasimhan on CNBC’s “Squawk on the Street” (M-F 9AM – 11AM ET) today, Wednesday, January 12th. Following is a link to video on CNBC.com:

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Novartis CEO: We’re Moving Toward Filing Covid Drug From Molecular Partners With FDA

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

MEG TIRRELL: Hey Carl. Dr. Vas Narasimhan, the CEO of Novartis, joins us now. Vas, it’s great to see you. Thanks for being here. You know, I want to start by the news you had this week on a potential COVID drug that you in-licensed from Molecular Partners. The data look really good, kind of similar to the antibody drugs. How quickly do you think this might be able to get through regulators and out to patients?

DR. VAS NARASIMHAN: Yeah, thanks Meg. Great to be here as always with you. This medicine ensovibep is pretty exciting. It's a novel technology called DARPin. It's a designed anchor and repeat protein that can target the COVID spike protein in three different locations. And what that allows this medicine to do in every in vitro test that we've done so far, is to be able to neutralize all of the COVID virus strains of concern pretty consistently. Now, this was the first data that we have clinically showing that the medicine is able to reduce viral load, speed up recovery time and have a 79% reduction in hospitalization and death. So right now, we're moving towards a filing with the FDA for an emergency use authorization. Our goal is to scale up manufacturing to begin to have supplies in the first half of this year with more scale up for the second half of this year. And the real vision here is to have a medicine that can be used hopefully independent of which strain COVID may mutate to in the future.

TIRRELL: And I understand because of sort of the way this drug is manufactured, you might be able to make it more quickly in larger quantities, what kinds of dose levels are you expecting in terms of the number of courses that could be available?

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

TIRRELL: And I understand Novartis is also working on perhaps a pan-coronavirus oral medication as well, which perhaps could go into clinical trials this year. Just tell us about kind of how you're looking at COVID and what solutions are going to be needed for it going forward? It doesn't sound like you think this is something that we're going to be done with at any point soon.

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

TIRRELL: Well, a longer-term view is something that I think a lot of people would welcome especially as we're seeing what's happening with testing right now. I also want to ask you about some other news of the day which is the Centers for Medicare & Medicaid Services coverage decision on the amyloid antibody drugs for Alzheimer's disease. You know, I wanted to ask you about this because you and I spoke after Biogen got that accelerated approval back in June and you noted, okay, there's this pathway, perhaps for drugs in neurology and maybe this is something that everybody in the industry should be looking at. Does the strict coverage decision from CMS change the opportunity you think you saw there from the FDA at all in neurology?

NARASIMHAN: Well, I think it's a unique set of circumstances we have here, one that certainly people who've been in the industry for a long periods of time have not really seen before where you have a set of trials which weren't always going in the same direction and some data that's somewhat hard to interpret. I think what it points to is that even in neuroscience, we need robustly done studies that demonstrate not only a biomarker benefit, but also a clinical benefit for patients, for payers to want to cover, cover a medicine. I think it also does point to the challenge we face that there are moments where the regulator has a view and then reimbursement bodies have a different view. This is something we've contended with in Europe for many years. In general, we would be proponents for regulators and reimbursement bodies to try to align their perspectives. I do think that this is a pretty unique circumstance with respect to the data and of course now the outcome from CMS.

TIRRELL: Alright, well Vas, we gotta leave it there. But we'd love to have you back because there's a lot more to talk about with Sandoz, the proceeds from your Roche stake sale, lots more so Vas, thanks for being with us.

NARASIMHAN: Thank you Meg.

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