This Drug Maker Saw the Pandemic Coming

Lead anticipate what so many others missed? But first, here's what happened today. For the eighth straight week, the number of Americans seeking unemployment and totaled in the millions as the economy continued to reel from the pandemic. Nearly three million people filed initial jobless claims last week, and while the number was lower than the week before, it was

higher than economists had predicted. Economists at Goldman Sachs Group revised their forecast for the peak unemployment rate in the US. They now say unemployment will hit twenty five percent before falling again, when they previously forecast a peak of fifteen percent. A serious but rare inflammatory disease in children, may have jumped thirtyfold because of coronavirus, according to an Italian study.

A detailed analysis from Bergamo, the city at the center of the Italian COVID nineteen outbreak, found ten cases of a COVID linked illness that resembles Kawasaki disease. All told, about a hundred such cases have been reported in It'll, New York, and England. The cases are challenging the previous understanding that the disease rarely made children very sick. Finally, Asian countries that were among the first affected by the coronavirus and the most successful in quelling its spread are

now fearing second waves. After containing their outbreaks through measures from strict lockdowns to rapid testing regimes, Hong Kong, South Korea, and China face resurgences of the disease even as they pursue aggressive testing and tracing. It's a reminder that untraceable flare ups are likely even after an extended lulling cases. Scientists have warned that the disease may never go away because it lurks in some people without causing any outward

signs of sickness and now our main store. The drug um Desevere, manufactured by Gilead Sciences, has offered one of the fewest lovers of hope about the virus to emerge in the last few months. In a clinical trial, ram desevere was shown to reduce the recovery time of patients who were seriously sick with COVID nineteen. Based on that trial, the Federal Food and Drug Administration authorized the drug for

emergency use. The promising results suggested the virus may be beatable and even buoyed the volatile stock market for a short while. Gilliad had enough of its drug ready to test and start manufacturing it at a larger scale because it had started stockpiling not just the drug but its ingredients at the first hint there may be a new coronavirus. I talked to Robert Langraff about why the company was able to act early to prepare for a pandemic when

so many businesses and institutions did not. So, Bob, how good is this drug? Well, the short inswers, we really don't know yet. Uh. It got an emergency author's use authorization by the Food and Drug Administration based basically on a single trial about a thousand patients conducted by the National Institute's of Health. According to the preliminary data, kind of it helped speed up recovery from the disease on the average by about four days. But none of the

data really has been published. We don't really know any of the details of the data. And then there's another study from China, much smaller study from China, you know, that failed to show a clear effect of the drug, also in hospitalized patients. So it's just the data is very very preliminary, preliminary, preliminary. Now, you know, doctors really haven't seen it has been invented or published, you know,

in medical journal. It is from you know, the n i H with a very good reputation, Tony Fauci's group. It you know, ni H help sponsor and conduct this, uh, this study. But you know, in terms of the fine details of whether there's a safe lives or not, you know, we just don't know yet. So you wouldn't necessarily call it a cure. No, I definitely would not necessarily call

it a cure. And uh, in you know discussing it, you know, early on when they kind of announced the results, Uh, Tony Faucci kind of like in this early trials, early trials, you know, a z T which was one of the uh, the first HIV drug, and that kind of was you know, proved quickly based on early evidence, but then you know, later on was you know, supplanted by you know, much more potent, stronger drug combinations. The way to think about

this is kind of, hey, it's a start. You know, it's a first, first drug we can use, and there We're gonna need many more drugs and vaccines in the future. So I'm wondering what are some of the issues with producing this drug in in large quantities. It's been likened to, you know, making you know, these very specialized complex chemicals sort of been liking to bake in a very you know, specialized,

fancy type of bread. You have to do, uh, you know, have to have all the right ingredients on hand in large quantities, and if you have to wait for the week to grow, so to speak, then you're you know, out of luck and you may have to wait a while. So you have to have all the ingredients on hand, and then you have to execute all the steps in the proper sequential order. And for this drug, there's more steps chemical steps than usually it's about the twenty five

different chemical steps depending on how you count. So basically at the start of the process, Gilly had Gilly had had some supply on hand, but they estimated that to make more of it would take you nine to twelve months from start to finish just to gather all the important raw materials and starting chemicals, then to produce the raw drug supply the raw they call it active pharmactical

sudical ingredients that's just like a bulk white powder. And then because this drug is not a pill, it's infused into viles, that there's an additional manufacturing step that's need and that they have to you have to dissolve it and put it into viles under very sterile conditions. H And that adds additional complexity to the process that you know,

a separate manufacturing plants. So all told, there's there's are quite a number of steps, and they've been able to get it down to about six months now by improving the process, but you know, it's still a lengthy, complicated process from start to finish. What was the original use case for rem desvier? Why was bill yad developing the drug. Yeah, so it's very interesting. They put a team together back in two thousand and fourteen, you know, looking at some

of their drugs for emerging viruses. And you know, one of the reasons they were looking at that is because that was like the big bowler outbreak in West Africa.

So they put together a team, you know, fifteen or twenty people looking at that, you know, what drugs might be good for some of these emerging viruses and remdesiviere, which is like in the test to work, we worked against a lot of viruses kind of jumped to the top of the list, but they weren't able to actually test it in people and for easy in a bowler until kind of the next bowl outbreak I was like twos eighteen tousand, nineteen, uh and the congo. Interestingly enough,

it didn't work well there. They got those results you know, last year. But in the process of testing it for a ball, I'm looking at it for other things. Some researchers at the head is working with at the University of North Carolina and Vanderbilt University Medical Center, you know, showed that it was really quite effective at least in the lab and the test tube type tests against a

whole variety of coronaviruses. When this COVID nineteam came aroung Long deserverre basically immediately became a you know, a prime

candidate to test as a drug against COVID nineteen. And currently how much supply is there of M devere So gill Lead is promising to donate the first one point five million vials of the drug, and that's you know, roughly enough to treat close to two hundred patients, you know, under a kind of existing regiments, And the US Department of Health and Humanity Services said that about six hundred thousand uh of those vials are going to earmarks so to speak, for the United States, that maybe that will

treat about seventy eight thousand patients here. So, you know, there's already a lot of debate over you know, which hospitals are getting it and why. Now Guilliad is not deciding that. The US government and the state governments are deciding that, but there's been a lot of confusion over you know what what you know, how is it being allocated different hospitals, and why do some parts of the country have a supply of this now and others don't how is that being decided. So Gillian is working very

hard to increase the supply. One key decision, you know, it made early on, was very early in January, as soon as it became clearly this thing, you know, it was caused by coronavirus and could potentially be significant, they put out a big, big order, like all the bulk supplies. They need to make a lot more of this drug, sort of like the equivalent of you know, all the specialized flower and all the specialized eggs and all the specialized butter and all the other ingredients that go into

your baking. They put a big, big order and because of that, you know, they're now in a position to start, you know, making much bigger supplies of it. And they're talking about having by fall enough to treat five hund thousand patients, but into the year enough to treat at least a million patients. So that's still going to take a number of months to role in. So it's still

right now, it's definitely in short supply. Now you mentioned that Gilliat is willing to donate a certain amount of the drug initially, but eventually they are going to have to charge for the drug. Is there any estimate of how much this drug is going to cost? Now Guilliad is not talking about it, and so it's too early

to talk about that. But uh, Wall Street, you know, is talking about that, and they're they're figuring, you know, it might be around three or four or five thousand dollars per course of treatment, you know, at least for you know, wealthier countries like the United States and Europe. So, as you mentioned, REM descivite is not a cure for COVID nineteen. And so in your estimate or your recommendation,

what are some other drugs or vaccines? What more research is needed to be done to maybe compliment REM decivere or maybe to actually find a cure for COVID nineteen. Well, there's just an immense I call almost a fire hose of drugs and trials and vaccines being tested. Now there's like literally more more than a hundred drugs and hundred vaccine means being either tested and trials are you know,

explored in preclinical trials. Um one approach on the drug front that a number of companies are working on is called monocle antibodies. This is antibodies would be directly against

COVID nineteen. Companies working on that include every General and Pharmaceuticals which made a successful treatment for a bowl are using the same type of approach, and so monoclon antibodies they be essentially when when you when you get get the virus and the coverent from it, you have antibodies to that virus that basically block the spike protein of the virus, which is how the virus gets into cells.

And so what these artificially made monoclon antibodies would be would essentially duplicate the natural process of creating antibodies, and except they pick out some antibodies and make you know, large quantities of them the factory and just inject them directly into you. And you could use these monoclon antibodies

two different ways. They could be used as a preventative treatment for people at very high risks, such as like versus doctor's first responders, and they could also be used to treat very sick patients UH with the disease and re General has talked about starting clinical trials with that approach in June, and there are several other drug companies also working on similar approaches. And these antibodes are viewed as one of the most promising treatment approaches or proven nineteen.

That was Bloomberg's Robert Langrath. His reporting on gile lead is the cover story of this week's issue of Bloomberg Business Week. And that's our show today. For coverage of the outbreak from bureaus around the world, visit Bloomberg dot com slash coronavirus and if you like the show, please leave us a review and a rating on Apple Podcasts or Spotify. It's the best way to help more listeners find our global reporting. The Prognosis Daily edition is of

to Me Laura Carlson. The show was produced by Me Topher foreheads, Jordan Gaspore and Magnus Hendrickson. Today's main story was reported by Robert Langrith. Original music by Leo Sidrin. Our editors are Francesca Levi and Rick Shine. Francesca Levi is Bloomberg's head of Podcasts. Thanks for listening.