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Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's stay two forty

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Speaker 1: nine since coronavirus was declared a global pandemic. Today's main

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Speaker 1: story when drugmaker Eli Lilly's antibody treatment was given the

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Speaker 1: green light from regulators. It was a breakthrough in keeping

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Speaker 1: infected patients from getting sicker. But the company CEO says

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Speaker 1: the soaring rate of cases in the US means it

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Speaker 1: may be impossible to make enough of the medicine. But first,

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Speaker 1: here's what happened in virus News today. A promising new

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Speaker 1: COVID nineteen vaccine is getting closer to being ready for

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Speaker 1: widespread distribution. Visor said a final annalo this showed its

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Speaker 1: vaccine was effective. That paved the way for the company

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Speaker 1: to apply for the first US regulatory authorization for a

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Speaker 1: coronavirus shot within days. Fiser and partner bio en Tech

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Speaker 1: said their vaccine protected people of all ages and ethnicities

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Speaker 1: with no significant safety problems so far in a trial

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Speaker 1: that includes almost forty four thousand participants. In Germany, a

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Speaker 1: protest over distancing and hygiene rules turned violent. Berlin police

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Speaker 1: used water cannons to break up a large demonstration near

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Speaker 1: the Brandenburg Gate, where thousands of people had gathered. Pressure

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Speaker 1: has been growing on German authorities, who are facing a

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Speaker 1: crunch meeting next week to lay out a long term

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Speaker 1: plan to fight the pandemic. With restrictions likely to be

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Speaker 1: extended and intensified, public anger and political tensions are rising.

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Speaker 1: The entire New York City Public school system will close

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Speaker 1: on Thursday, according to an email from Chancellor Richard Carranza

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Speaker 1: to School Principles. The shutdown was prompted by New York

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Speaker 1: City reaching a three percent test positivity rate over a

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Speaker 1: seven day rolling average. Moving to distance learning will affect

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Speaker 1: the approximately three hundred thousand children who have been attending

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Speaker 1: in person classes since schools reopened in early October. Finally,

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Speaker 1: the US gave the green light for the first COVID

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Speaker 1: nineteen self testing kit, adding a tool to battle the

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Speaker 1: pandemic as nationwide testing capabilities come under more strain. The

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Speaker 1: Food and Drug Administration issued an emergency use authorization to

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Speaker 1: la Sierra Health's Rapid Result all in one test kit.

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Speaker 1: While some COVID nineteen tests allow people to provide samples

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Speaker 1: from home, this is the first that can be fully

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Speaker 1: self administered and provide results at home in thirty minutes

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Speaker 1: or less, and now for today's main story. In a

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Speaker 1: mere nine months, Eli Lily accomplished an unprecedented feat. The

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Speaker 1: drug giant took a blood sample from one of the

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Speaker 1: first US patients to recover from COVID nineteen, identified an

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Speaker 1: antibody that could fight the virus, and created a version

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Speaker 1: of that antibody to treat people with the disease. Reporter

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Speaker 1: Riley Griffin spoke to Lily's chief executive officer, David Ricks

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Speaker 1: about the challenges facing the company and its new treatment

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Speaker 1: among the worsening pandemic. So, Riley, you spoke to Lily's

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Speaker 1: chief executive officer, David ris just after they were given

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Speaker 1: the green light from regulators about their new antibody treatment.

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Speaker 1: I was wondering if you might give us a brief

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Speaker 1: introduction to exactly how Lily's treatment works. Absolutely so, what

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Speaker 1: this class of treatments, known as monoclonal antibodies is is

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Speaker 1: there man made versions of antibodies that the body produces

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Speaker 1: in response to the infection of the novel coronavirus. So

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Speaker 1: Lily and its partner Abseller actually identified one of the

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Speaker 1: earliest patients in the US who have recovered from the

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Speaker 1: coronavirus and back in the early months of the pandemic

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Speaker 1: um they used that information, that sample to create their

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Speaker 1: own product. And it's an intravenous injection that you receive

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Speaker 1: in a hospital setting and an outpatient setting, and it

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Speaker 1: ultimately it's best use as we know right now, is

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Speaker 1: to treat those with COVID nineteen that are at early

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Speaker 1: stages of symptoms, so not those who have progressed to

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Speaker 1: the hospitalized setting. Obviously, this is great news. And what

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Speaker 1: was David Rick's reaction to news of the approval when

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Speaker 1: you spoke to him, David Ricks was incredibly excited. Yeah, well,

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Speaker 1: obviously we're excited, and I'm most excited for the scientists

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Speaker 1: who I know who work at our company. And we're

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Speaker 1: not done, of course, we can, as you know where

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Speaker 1: working on improve versions and getting a full license for this.

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Speaker 1: Would like to get it approved in Europe and other countries,

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Speaker 1: but perhaps it's the end of the beginning for very

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Speaker 1: effective treatments for newly diagnosed patients with stars code two.

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Speaker 1: This is a scientific feat that those that Lily, those seller,

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Speaker 1: those that the n i H are so excited about.

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Speaker 1: It is a tool seen as a bridge to a

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Speaker 1: vaccine to treat those at the early stages of their

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Speaker 1: disease and prevent them from progressing to the hospitalized setting.

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Speaker 1: So it's another thing to add to the toolkit of

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Speaker 1: doctors who are looking to treat those with COVID nineteen,

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Speaker 1: particularly in a moment where we are seeing global surges

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Speaker 1: in cases. This green light is certainly good news. Challenges

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Speaker 1: are not over yet. I mean, what would you say

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Speaker 1: is the biggest hurdle that Lily is anticipating in say,

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Speaker 1: the weeks or months to come. Lily is quite concerned

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Speaker 1: about supply. I think the most notable thing out of

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Speaker 1: this conversation with David Ricks was really that capacity. No

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Speaker 1: matter how much manufacturing capacity they have, no matter how

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Speaker 1: many deals they reach for additional firepower to boost supply,

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Speaker 1: there simply is not going to be enough. The real

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Speaker 1: challenge is about scale. I don't think we would have

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Speaker 1: for difted back in April when we triggered the decision

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Speaker 1: to start manufacturing at pretty big scale million doses this

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Speaker 1: fall that we may need all of those. And then

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Speaker 1: so it occurred to us, you know a few months

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Speaker 1: later that might be true. And now we're in the

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Speaker 1: middle of the surge and I think we did everything

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Speaker 1: we could, but still it may not be enough. So

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Speaker 1: we have to continue try to squeeze out as much

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Speaker 1: supply as we can, and unfortunately that's not a quick

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Speaker 1: turnaround time, but clearly we'll be needed. Um, it's really

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Speaker 1: quite concerning to David Ricks. I'll have you know that

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Speaker 1: within the first week they've shipped out eighty eight thousand

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Speaker 1: doses of this antibody, but just consider the sheer number

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Speaker 1: of cases on a daily basis. So with any new

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Speaker 1: treatment for COVID nineteen, concerns are tied up with distribution.

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Speaker 1: Who will be able or eligible to receive the new

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Speaker 1: antibody therapy from Lily. The Food and Drug Administration has

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Speaker 1: authorized the experimental treatment for use against mild to moderate

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Speaker 1: COVID nineteen in adults, including those who are sixty five

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Speaker 1: and older, as well as pediatric patients. Lily will supply

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Speaker 1: the product, but the US and a distributing partner will

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Speaker 1: determine how to allocate this product based on need, So

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Speaker 1: where there are cases, it will proportionately be distributed to states, territories, municipalities, cities,

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Speaker 1: and so forth. It will take a little bit of

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Speaker 1: time for doctors to learn about this and start getting

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Speaker 1: getting their own experience. But that's against the background of

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Speaker 1: probably something like a million patients diagnosed with COVID nineteen

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Speaker 1: this week in the United States. Amongst those million, we

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Speaker 1: would estimate something like or high risk. So design enough

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Speaker 1: supply to go around the US is going to have

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Speaker 1: a challenging time at that sub level, at the local level,

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Speaker 1: determining who is high risk within this camp, because the

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Speaker 1: number of mild to moderate nineteen patients in this country

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Speaker 1: is massive at this point in time as we see

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Speaker 1: a US surge unfold. So Riley, you've already identified some

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Speaker 1: serious challenges just on the US level, and Lily has

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Speaker 1: agreed to supply the US with the initial three hundred

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Speaker 1: thousand vials of the therapy, but there will be obvious

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Speaker 1: global demand for this therapy. How is Lily going to

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Speaker 1: meet that demand? This is a fascinating question because Lily

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Speaker 1: is approaching the question of supply and demand very differently

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Speaker 1: than we're seeing others who are developing both treatments and vaccines. Um,

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Speaker 1: Lily did clinch this deal for three hundred thousand vials

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Speaker 1: of the antibody treatment, but the U S has this

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Speaker 1: option to purchase an additional six hundred and fifty thousand vials.

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Speaker 1: Now you got to read the fine print in that,

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Speaker 1: because those six fifty thou vials will only go to

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Speaker 1: the US if Lily and the federal government determined that

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Speaker 1: the need is high here and higher than elsewhere. We

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Speaker 1: know we have more capacity. At the time we signed

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Speaker 1: that deal, interested in making sure that there was access

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Speaker 1: to this medicine no matter where the disease was. You know,

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Speaker 1: it's raging in Europe as well. Of course, Europe hasn't

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Speaker 1: approved the drug and they haven't contracted with US yet.

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Speaker 1: So while that's the case, I think our ability to

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Speaker 1: get more drug to the US will go up because

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Speaker 1: they've got this option. But the option is a two

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Speaker 1: way option, so that both parties need to agree. So

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Speaker 1: it's an agreement to agree later, and it is currently

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Speaker 1: designed to kick in two months after the initial emergency

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Speaker 1: use of authorization. I'll tell you if if no other

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Speaker 1: country approves this or contracts, then we'll be at liberty

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Speaker 1: to just get more products to US patients who need it.

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Speaker 1: If Europe approves this quickly and wants to contract again

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Speaker 1: at the same race as the US we'll we'll shift

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Speaker 1: product to them as well. There's of epidemic and particularly

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Speaker 1: in France right now that it's very concerning. So um,

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Speaker 1: you know, we want to get the product to where

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Speaker 1: it's needed. Most many of the companies that have agreed

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Speaker 1: to deals with Operation Warp Speed have agreed flat out

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Speaker 1: here is a price that they receive for a dose. Right.

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Speaker 1: But Lily with these vials, is saying you can have

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Speaker 1: these vials if and only if there is significant need. Now,

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Speaker 1: what Ricks did say is it's looking like there is

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Speaker 1: going to be significant need here in the US as

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Speaker 1: the pandemic surges on. But we'll we'll wait to see

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Speaker 1: in the months to come whether it taps into that supply.

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Speaker 1: So Riley, finally, how does Lily anticipate working with the

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Speaker 1: Biden administration? Have the results of the election changed any

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Speaker 1: of their plans? Rix made a fascinating point here, which

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Speaker 1: is Operation Warp Speed is working eli Lillian Company and

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Speaker 1: the broader drug industry is incredibly supportive and in fact

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Speaker 1: applauds the work of the White House lead Operation Warp

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Speaker 1: Speed effort. An important thing to note, however, is that

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Speaker 1: Lily has not taken capital from Operation warp Speed for

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Speaker 1: its R and D or its manufacturing. The deal it's

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Speaker 1: clinched is for supply and supply alone. You might know

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Speaker 1: the name Visor at this point and its partner by

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Speaker 1: on Tech. They're in a similar camp. Those two companies

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Speaker 1: did not take money for research and development or manufacturing capacity,

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Speaker 1: but really just those doses. And that's quite novel. Again,

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Speaker 1: it's different from those like Johnson and Johnson or Maderna

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Speaker 1: or even Regeneration here in the antibody space that I've

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Speaker 1: taken money for initial research. It was very important for

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Speaker 1: Lily to have put down that risky investment from the

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Speaker 1: get go, and we will see what liberties that will

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Speaker 1: allow them moving forward both amid the pandemic in a

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Speaker 1: post pandemic world. That was Riley Griffin. And that's it

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Speaker 1: for our show today. For coverage of the outbreak from

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Speaker 1: one and twenty bureaus around the world, visit Bloomberg dot

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Speaker 1: com slash Coronavirus and if you like the show, please

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Speaker 1: leave us a review and a rating on Apple. Podcasts

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Speaker 1: are Spotify. It's the best way to help more listeners

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Speaker 1: find our global reporting. The Prognosis Daily edition is produced

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Speaker 1: by Topha foreheads Jordan Gospure, Magnus Henrickson, and me Laura Carlson.

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Speaker 1: Today's main story was reported by Riley Griffin. Original music

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Speaker 1: by Leo Sidrin. Our editors are Rick Shine and Francesco Levi.

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Speaker 1: Francesco Levi is Bloomberg's head of podcasts. Thanks for listening

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Speaker 1: to