WEBVTT - This Drug Maker Saw the Pandemic Coming 0:00:03.200 --> 0:00:08.480 Welcome to Prognosis. I'm Laura Carlson. It's stay sixty four. 0:00:08.640 --> 0:00:13.280 Since coronavirus was declared a global pandemic our main story. 0:00:14.280 --> 0:00:17.840 Many governments and companies were caught off guard by the 0:00:17.920 --> 0:00:23.439 devastating spread of the coronavirus. But Gilliad Sciences was different. 0:00:24.480 --> 0:00:28.320 The company had vials of its experimental COVID nineteen drug 0:00:28.440 --> 0:00:32.720 from Desevere ready to put into a clinical trial, and 0:00:32.960 --> 0:00:36.400 it had everything it needed to spring into production when 0:00:36.400 --> 0:00:40.720 the drug was approved for emergency use. How did gill 0:00:40.800 --> 0:00:47.000 Lead anticipate what so many others missed? But first, here's 0:00:47.000 --> 0:00:58.080 what happened today. For the eighth straight week, the number 0:00:58.080 --> 0:01:02.480 of Americans seeking unemployment and totaled in the millions as 0:01:02.480 --> 0:01:07.559 the economy continued to reel from the pandemic. Nearly three 0:01:07.640 --> 0:01:11.679 million people filed initial jobless claims last week, and while 0:01:11.760 --> 0:01:14.520 the number was lower than the week before, it was 0:01:14.680 --> 0:01:20.160 higher than economists had predicted. Economists at Goldman Sachs Group 0:01:20.319 --> 0:01:23.880 revised their forecast for the peak unemployment rate in the US. 0:01:24.880 --> 0:01:28.360 They now say unemployment will hit twenty five percent before 0:01:28.400 --> 0:01:33.360 falling again, when they previously forecast a peak of fifteen percent. 0:01:34.800 --> 0:01:38.399 A serious but rare inflammatory disease in children, may have 0:01:38.520 --> 0:01:43.200 jumped thirtyfold because of coronavirus, according to an Italian study. 0:01:44.280 --> 0:01:47.360 A detailed analysis from Bergamo, the city at the center 0:01:47.400 --> 0:01:51.560 of the Italian COVID nineteen outbreak, found ten cases of 0:01:51.600 --> 0:01:57.000 a COVID linked illness that resembles Kawasaki disease. All told, 0:01:57.080 --> 0:02:00.000 about a hundred such cases have been reported in It'll, 0:02:00.440 --> 0:02:05.040 New York, and England. The cases are challenging the previous 0:02:05.160 --> 0:02:11.119 understanding that the disease rarely made children very sick. Finally, 0:02:11.400 --> 0:02:13.840 Asian countries that were among the first affected by the 0:02:13.840 --> 0:02:18.040 coronavirus and the most successful in quelling its spread are 0:02:18.120 --> 0:02:23.000 now fearing second waves. After containing their outbreaks through measures 0:02:23.040 --> 0:02:27.920 from strict lockdowns to rapid testing regimes, Hong Kong, South Korea, 0:02:28.200 --> 0:02:32.280 and China face resurgences of the disease even as they 0:02:32.360 --> 0:02:38.040 pursue aggressive testing and tracing. It's a reminder that untraceable 0:02:38.040 --> 0:02:42.240 flare ups are likely even after an extended lulling cases. 0:02:43.160 --> 0:02:47.079 Scientists have warned that the disease may never go away 0:02:47.160 --> 0:02:50.840 because it lurks in some people without causing any outward 0:02:50.880 --> 0:03:02.520 signs of sickness and now our main store. The drug 0:03:02.760 --> 0:03:06.920 um Desevere, manufactured by Gilead Sciences, has offered one of 0:03:06.919 --> 0:03:09.560 the fewest lovers of hope about the virus to emerge 0:03:09.560 --> 0:03:13.280 in the last few months. In a clinical trial, ram 0:03:13.320 --> 0:03:16.280 desevere was shown to reduce the recovery time of patients 0:03:16.480 --> 0:03:21.520 who were seriously sick with COVID nineteen. Based on that trial, 0:03:21.680 --> 0:03:25.160 the Federal Food and Drug Administration authorized the drug for 0:03:25.200 --> 0:03:30.280 emergency use. The promising results suggested the virus may be 0:03:30.280 --> 0:03:34.040 beatable and even buoyed the volatile stock market for a 0:03:34.120 --> 0:03:38.800 short while. Gilliad had enough of its drug ready to 0:03:38.840 --> 0:03:42.440 test and start manufacturing it at a larger scale because 0:03:42.440 --> 0:03:45.800 it had started stockpiling not just the drug but its 0:03:45.920 --> 0:03:50.120 ingredients at the first hint there may be a new coronavirus. 0:03:51.400 --> 0:03:54.200 I talked to Robert Langraff about why the company was 0:03:54.240 --> 0:03:57.880 able to act early to prepare for a pandemic when 0:03:57.920 --> 0:04:07.120 so many businesses and institutions did not. So, Bob, how 0:04:07.200 --> 0:04:10.800 good is this drug? Well, the short inswers, we really 0:04:10.840 --> 0:04:14.480 don't know yet. Uh. It got an emergency author's use 0:04:14.560 --> 0:04:17.920 authorization by the Food and Drug Administration based basically on 0:04:17.960 --> 0:04:20.919 a single trial about a thousand patients conducted by the 0:04:21.000 --> 0:04:24.360 National Institute's of Health. According to the preliminary data, kind 0:04:24.360 --> 0:04:27.400 of it helped speed up recovery from the disease on 0:04:27.400 --> 0:04:30.520 the average by about four days. But none of the 0:04:30.560 --> 0:04:32.480 data really has been published. We don't really know any 0:04:32.520 --> 0:04:34.320 of the details of the data. And then there's another 0:04:34.400 --> 0:04:38.000 study from China, much smaller study from China, you know, 0:04:38.040 --> 0:04:39.880 that failed to show a clear effect of the drug, 0:04:40.400 --> 0:04:43.320 also in hospitalized patients. So it's just the data is 0:04:43.400 --> 0:04:46.520 very very preliminary, preliminary, preliminary. Now, you know, doctors really 0:04:46.520 --> 0:04:48.640 haven't seen it has been invented or published, you know, 0:04:48.640 --> 0:04:51.039 in medical journal. It is from you know, the n 0:04:51.040 --> 0:04:54.120 i H with a very good reputation, Tony Fauci's group. 0:04:54.120 --> 0:04:56.880 It you know, ni H help sponsor and conduct this, uh, 0:04:56.960 --> 0:04:59.240 this study. But you know, in terms of the fine 0:04:59.320 --> 0:05:01.960 details of whether there's a safe lives or not, you know, 0:05:02.000 --> 0:05:05.000 we just don't know yet. So you wouldn't necessarily call 0:05:05.040 --> 0:05:07.920 it a cure. No, I definitely would not necessarily call 0:05:07.920 --> 0:05:10.719 it a cure. And uh, in you know discussing it, 0:05:10.839 --> 0:05:14.159 you know, early on when they kind of announced the results, Uh, 0:05:14.360 --> 0:05:17.240 Tony Faucci kind of like in this early trials, early trials, 0:05:17.440 --> 0:05:20.320 you know, a z T which was one of the uh, 0:05:20.440 --> 0:05:23.200 the first HIV drug, and that kind of was you know, 0:05:23.320 --> 0:05:26.440 proved quickly based on early evidence, but then you know, 0:05:26.520 --> 0:05:28.720 later on was you know, supplanted by you know, much 0:05:29.279 --> 0:05:32.799 more potent, stronger drug combinations. The way to think about 0:05:32.839 --> 0:05:34.599 this is kind of, hey, it's a start. You know, 0:05:34.640 --> 0:05:37.120 it's a first, first drug we can use, and there 0:05:37.160 --> 0:05:40.520 We're gonna need many more drugs and vaccines in the future. 0:05:41.720 --> 0:05:44.800 So I'm wondering what are some of the issues with 0:05:45.000 --> 0:05:49.039 producing this drug in in large quantities. It's been likened to, 0:05:49.400 --> 0:05:52.839 you know, making you know, these very specialized complex chemicals 0:05:52.839 --> 0:05:55.800 sort of been liking to bake in a very you know, specialized, 0:05:55.839 --> 0:05:58.120 fancy type of bread. You have to do, uh, you know, 0:05:58.200 --> 0:06:00.440 have to have all the right ingredients on hand in 0:06:00.560 --> 0:06:02.560 large quantities, and if you have to wait for the 0:06:02.560 --> 0:06:04.480 week to grow, so to speak, then you're you know, 0:06:04.520 --> 0:06:05.960 out of luck and you may have to wait a while. 0:06:06.200 --> 0:06:07.960 So you have to have all the ingredients on hand, 0:06:08.000 --> 0:06:09.760 and then you have to execute all the steps in 0:06:09.800 --> 0:06:12.720 the proper sequential order. And for this drug, there's more 0:06:12.720 --> 0:06:15.760 steps chemical steps than usually it's about the twenty five 0:06:15.839 --> 0:06:18.880 different chemical steps depending on how you count. So basically 0:06:18.880 --> 0:06:21.120 at the start of the process, Gilly had Gilly had 0:06:21.160 --> 0:06:24.000 had some supply on hand, but they estimated that to 0:06:24.040 --> 0:06:25.839 make more of it would take you nine to twelve 0:06:25.839 --> 0:06:28.640 months from start to finish just to gather all the 0:06:28.680 --> 0:06:31.960 important raw materials and starting chemicals, then to produce the 0:06:32.080 --> 0:06:34.800 raw drug supply the raw they call it active pharmactical 0:06:34.839 --> 0:06:37.599 sudical ingredients that's just like a bulk white powder. And 0:06:37.640 --> 0:06:40.440 then because this drug is not a pill, it's infused 0:06:40.600 --> 0:06:43.839 into viles, that there's an additional manufacturing step that's need 0:06:43.839 --> 0:06:45.640 and that they have to you have to dissolve it 0:06:45.680 --> 0:06:49.120 and put it into viles under very sterile conditions. H 0:06:49.120 --> 0:06:51.520 And that adds additional complexity to the process that you know, 0:06:51.520 --> 0:06:55.159 a separate manufacturing plants. So all told, there's there's are 0:06:55.200 --> 0:06:58.480 quite a number of steps, and they've been able to 0:06:58.520 --> 0:07:01.960 get it down to about six months now by improving 0:07:02.080 --> 0:07:05.440 the process, but you know, it's still a lengthy, complicated 0:07:05.680 --> 0:07:09.360 process from start to finish. What was the original use 0:07:09.440 --> 0:07:12.720 case for rem desvier? Why was bill yad developing the drug. Yeah, 0:07:12.800 --> 0:07:16.360 so it's very interesting. They put a team together back 0:07:16.360 --> 0:07:18.040 in two thousand and fourteen, you know, looking at some 0:07:18.080 --> 0:07:21.360 of their drugs for emerging viruses. And you know, one 0:07:21.400 --> 0:07:23.200 of the reasons they were looking at that is because 0:07:23.280 --> 0:07:26.640 that was like the big bowler outbreak in West Africa. 0:07:26.720 --> 0:07:28.560 So they put together a team, you know, fifteen or 0:07:28.560 --> 0:07:30.960 twenty people looking at that, you know, what drugs might 0:07:30.960 --> 0:07:33.280 be good for some of these emerging viruses and remdesiviere, 0:07:33.320 --> 0:07:35.200 which is like in the test to work, we worked 0:07:35.240 --> 0:07:38.440 against a lot of viruses kind of jumped to the 0:07:38.480 --> 0:07:40.800 top of the list, but they weren't able to actually 0:07:40.880 --> 0:07:43.640 test it in people and for easy in a bowler 0:07:43.680 --> 0:07:45.560 until kind of the next bowl outbreak I was like 0:07:45.560 --> 0:07:49.960 twos eighteen tousand, nineteen, uh and the congo. Interestingly enough, 0:07:50.000 --> 0:07:52.960 it didn't work well there. They got those results you know, 0:07:53.040 --> 0:07:55.960 last year. But in the process of testing it for 0:07:56.000 --> 0:07:58.040 a ball, I'm looking at it for other things. Some 0:07:58.120 --> 0:08:01.200 researchers at the head is working with at the University 0:08:01.200 --> 0:08:04.360 of North Carolina and Vanderbilt University Medical Center, you know, 0:08:04.480 --> 0:08:06.920 showed that it was really quite effective at least in 0:08:06.920 --> 0:08:09.880 the lab and the test tube type tests against a 0:08:09.920 --> 0:08:13.800 whole variety of coronaviruses. When this COVID nineteam came aroung 0:08:14.160 --> 0:08:17.320 Long deserverre basically immediately became a you know, a prime 0:08:17.400 --> 0:08:29.840 candidate to test as a drug against COVID nineteen. And 0:08:30.080 --> 0:08:33.880 currently how much supply is there of M devere So 0:08:34.080 --> 0:08:37.920 gill Lead is promising to donate the first one point 0:08:38.000 --> 0:08:40.880 five million vials of the drug, and that's you know, 0:08:41.040 --> 0:08:44.720 roughly enough to treat close to two hundred patients, you know, 0:08:44.760 --> 0:08:48.320 under a kind of existing regiments, And the US Department 0:08:48.320 --> 0:08:51.319 of Health and Humanity Services said that about six hundred 0:08:51.400 --> 0:08:54.960 thousand uh of those vials are going to earmarks so 0:08:55.040 --> 0:08:57.280 to speak, for the United States, that maybe that will 0:08:57.280 --> 0:08:59.760 treat about seventy eight thousand patients here. So, you know, 0:09:00.120 --> 0:09:03.320 there's already a lot of debate over you know, which 0:09:03.320 --> 0:09:05.600 hospitals are getting it and why. Now Guilliad is not 0:09:05.960 --> 0:09:08.520 deciding that. The US government and the state governments are 0:09:08.520 --> 0:09:11.520 deciding that, but there's been a lot of confusion over 0:09:11.600 --> 0:09:13.360 you know what what you know, how is it being 0:09:13.400 --> 0:09:15.560 allocated different hospitals, and why do some parts of the 0:09:15.559 --> 0:09:18.720 country have a supply of this now and others don't 0:09:18.800 --> 0:09:22.439 how is that being decided. So Gillian is working very 0:09:22.520 --> 0:09:25.920 hard to increase the supply. One key decision, you know, 0:09:25.920 --> 0:09:28.960 it made early on, was very early in January, as 0:09:29.000 --> 0:09:30.480 soon as it became clearly this thing, you know, it 0:09:30.600 --> 0:09:33.360 was caused by coronavirus and could potentially be significant, they 0:09:33.400 --> 0:09:36.600 put out a big, big order, like all the bulk supplies. 0:09:36.840 --> 0:09:38.400 They need to make a lot more of this drug, 0:09:38.880 --> 0:09:40.800 sort of like the equivalent of you know, all the 0:09:40.840 --> 0:09:43.040 specialized flower and all the specialized eggs and all the 0:09:43.040 --> 0:09:45.240 specialized butter and all the other ingredients that go into 0:09:45.240 --> 0:09:47.800 your baking. They put a big, big order and because 0:09:47.800 --> 0:09:49.880 of that, you know, they're now in a position to start, 0:09:49.920 --> 0:09:52.480 you know, making much bigger supplies of it. And they're 0:09:52.520 --> 0:09:55.040 talking about having by fall enough to treat five hund 0:09:55.120 --> 0:09:56.840 thousand patients, but into the year enough to treat at 0:09:56.880 --> 0:09:59.199 least a million patients. So that's still going to take 0:09:59.200 --> 0:10:00.960 a number of months to role in. So it's still 0:10:01.080 --> 0:10:04.160 right now, it's definitely in short supply. Now you mentioned 0:10:04.160 --> 0:10:07.200 that Gilliat is willing to donate a certain amount of 0:10:07.280 --> 0:10:10.560 the drug initially, but eventually they are going to have 0:10:10.600 --> 0:10:13.400 to charge for the drug. Is there any estimate of 0:10:13.440 --> 0:10:16.319 how much this drug is going to cost? Now Guilliad 0:10:16.400 --> 0:10:17.960 is not talking about it, and so it's too early 0:10:18.000 --> 0:10:20.400 to talk about that. But uh, Wall Street, you know, 0:10:20.559 --> 0:10:22.800 is talking about that, and they're they're figuring, you know, 0:10:22.840 --> 0:10:25.120 it might be around three or four or five thousand 0:10:25.160 --> 0:10:28.400 dollars per course of treatment, you know, at least for 0:10:28.600 --> 0:10:32.559 you know, wealthier countries like the United States and Europe. So, 0:10:32.600 --> 0:10:35.560 as you mentioned, REM descivite is not a cure for 0:10:35.600 --> 0:10:40.000 COVID nineteen. And so in your estimate or your recommendation, 0:10:40.720 --> 0:10:43.360 what are some other drugs or vaccines? What more research 0:10:43.440 --> 0:10:46.680 is needed to be done to maybe compliment REM decivere 0:10:46.840 --> 0:10:50.360 or maybe to actually find a cure for COVID nineteen. Well, 0:10:50.480 --> 0:10:54.360 there's just an immense I call almost a fire hose 0:10:54.400 --> 0:10:57.440 of drugs and trials and vaccines being tested. Now there's 0:10:57.440 --> 0:10:59.640 like literally more more than a hundred drugs and hundred 0:10:59.720 --> 0:11:03.440 vaccine means being either tested and trials are you know, 0:11:03.520 --> 0:11:07.120 explored in preclinical trials. Um one approach on the drug 0:11:07.200 --> 0:11:09.600 front that a number of companies are working on is 0:11:09.640 --> 0:11:13.680 called monocle antibodies. This is antibodies would be directly against 0:11:13.720 --> 0:11:17.880 COVID nineteen. Companies working on that include every General and 0:11:17.880 --> 0:11:21.880 Pharmaceuticals which made a successful treatment for a bowl are 0:11:21.960 --> 0:11:25.480 using the same type of approach, and so monoclon antibodies 0:11:25.520 --> 0:11:29.000 they be essentially when when you when you get get 0:11:29.000 --> 0:11:32.079 the virus and the coverent from it, you have antibodies 0:11:32.080 --> 0:11:34.959 to that virus that basically block the spike protein of 0:11:35.040 --> 0:11:37.720 the virus, which is how the virus gets into cells. 0:11:37.840 --> 0:11:41.680 And so what these artificially made monoclon antibodies would be 0:11:41.720 --> 0:11:46.320 would essentially duplicate the natural process of creating antibodies, and 0:11:46.480 --> 0:11:49.240 except they pick out some antibodies and make you know, 0:11:49.400 --> 0:11:51.960 large quantities of them the factory and just inject them 0:11:52.160 --> 0:11:55.400 directly into you. And you could use these monoclon antibodies 0:11:55.400 --> 0:11:57.600 two different ways. They could be used as a preventative 0:11:57.640 --> 0:11:59.800 treatment for people at very high risks, such as like 0:12:00.040 --> 0:12:03.000 versus doctor's first responders, and they could also be used 0:12:03.040 --> 0:12:06.200 to treat very sick patients UH with the disease and 0:12:06.760 --> 0:12:09.760 re General has talked about starting clinical trials with that 0:12:09.880 --> 0:12:12.760 approach in June, and there are several other drug companies 0:12:12.800 --> 0:12:15.600 also working on similar approaches. And these antibodes are viewed 0:12:15.600 --> 0:12:19.439 as one of the most promising treatment approaches or proven nineteen. 0:12:28.640 --> 0:12:32.880 That was Bloomberg's Robert Langrath. His reporting on gile lead 0:12:33.120 --> 0:12:35.880 is the cover story of this week's issue of Bloomberg 0:12:35.920 --> 0:12:40.000 Business Week. And that's our show today. For coverage of 0:12:40.000 --> 0:12:44.160 the outbreak from bureaus around the world, visit Bloomberg dot 0:12:44.200 --> 0:12:49.000 com slash coronavirus and if you like the show, please 0:12:49.080 --> 0:12:51.720 leave us a review and a rating on Apple Podcasts 0:12:51.800 --> 0:12:55.200 or Spotify. It's the best way to help more listeners 0:12:55.360 --> 0:12:59.679 find our global reporting. The Prognosis Daily edition is of 0:12:59.840 --> 0:13:03.320 to Me Laura Carlson. The show was produced by Me 0:13:03.720 --> 0:13:09.640 Topher foreheads, Jordan Gaspore and Magnus Hendrickson. Today's main story 0:13:09.880 --> 0:13:14.240 was reported by Robert Langrith. Original music by Leo Sidrin. 0:13:14.840 --> 0:13:19.640 Our editors are Francesca Levi and Rick Shine. Francesca Levi 0:13:20.000 --> 0:13:23.200 is Bloomberg's head of Podcasts. Thanks for listening.