Speaker 1: Welcome to Prognosis. I'm Laura Carlson. It's stay two forty
Speaker 1: nine since coronavirus was declared a global pandemic. Today's main
Speaker 1: story when drugmaker Eli Lilly's antibody treatment was given the
Speaker 1: green light from regulators. It was a breakthrough in keeping
Speaker 1: infected patients from getting sicker. But the company CEO says
Speaker 1: the soaring rate of cases in the US means it
Speaker 1: may be impossible to make enough of the medicine. But first,
Speaker 1: here's what happened in virus News today. A promising new
Speaker 1: COVID nineteen vaccine is getting closer to being ready for
Speaker 1: widespread distribution. Visor said a final annalo this showed its
Speaker 1: vaccine was effective. That paved the way for the company
Speaker 1: to apply for the first US regulatory authorization for a
Speaker 1: coronavirus shot within days. Fiser and partner bio en Tech
Speaker 1: said their vaccine protected people of all ages and ethnicities
Speaker 1: with no significant safety problems so far in a trial
Speaker 1: that includes almost forty four thousand participants. In Germany, a
Speaker 1: protest over distancing and hygiene rules turned violent. Berlin police
Speaker 1: used water cannons to break up a large demonstration near
Speaker 1: the Brandenburg Gate, where thousands of people had gathered. Pressure
Speaker 1: has been growing on German authorities, who are facing a
Speaker 1: crunch meeting next week to lay out a long term
Speaker 1: plan to fight the pandemic. With restrictions likely to be
Speaker 1: extended and intensified, public anger and political tensions are rising.
Speaker 1: The entire New York City Public school system will close
Speaker 1: on Thursday, according to an email from Chancellor Richard Carranza
Speaker 1: to School Principles. The shutdown was prompted by New York
Speaker 1: City reaching a three percent test positivity rate over a
Speaker 1: seven day rolling average. Moving to distance learning will affect
Speaker 1: the approximately three hundred thousand children who have been attending
Speaker 1: in person classes since schools reopened in early October. Finally,
Speaker 1: the US gave the green light for the first COVID
Speaker 1: nineteen self testing kit, adding a tool to battle the
Speaker 1: pandemic as nationwide testing capabilities come under more strain. The
Speaker 1: Food and Drug Administration issued an emergency use authorization to
Speaker 1: la Sierra Health's Rapid Result all in one test kit.
Speaker 1: While some COVID nineteen tests allow people to provide samples
Speaker 1: from home, this is the first that can be fully
Speaker 1: self administered and provide results at home in thirty minutes
Speaker 1: or less, and now for today's main story. In a
Speaker 1: mere nine months, Eli Lily accomplished an unprecedented feat. The
Speaker 1: drug giant took a blood sample from one of the
Speaker 1: first US patients to recover from COVID nineteen, identified an
Speaker 1: antibody that could fight the virus, and created a version
Speaker 1: of that antibody to treat people with the disease. Reporter
Speaker 1: Riley Griffin spoke to Lily's chief executive officer, David Ricks
Speaker 1: about the challenges facing the company and its new treatment
Speaker 1: among the worsening pandemic. So, Riley, you spoke to Lily's
Speaker 1: chief executive officer, David ris just after they were given
Speaker 1: the green light from regulators about their new antibody treatment.
Speaker 1: I was wondering if you might give us a brief
Speaker 1: introduction to exactly how Lily's treatment works. Absolutely so, what
Speaker 1: this class of treatments, known as monoclonal antibodies is is
Speaker 1: there man made versions of antibodies that the body produces
Speaker 1: in response to the infection of the novel coronavirus. So
Speaker 1: Lily and its partner Abseller actually identified one of the
Speaker 1: earliest patients in the US who have recovered from the
Speaker 1: coronavirus and back in the early months of the pandemic
Speaker 1: um they used that information, that sample to create their
Speaker 1: own product. And it's an intravenous injection that you receive
Speaker 1: in a hospital setting and an outpatient setting, and it
Speaker 1: ultimately it's best use as we know right now, is
Speaker 1: to treat those with COVID nineteen that are at early
Speaker 1: stages of symptoms, so not those who have progressed to
Speaker 1: the hospitalized setting. Obviously, this is great news. And what
Speaker 1: was David Rick's reaction to news of the approval when
Speaker 1: you spoke to him, David Ricks was incredibly excited. Yeah, well,
Speaker 1: obviously we're excited, and I'm most excited for the scientists
Speaker 1: who I know who work at our company. And we're
Speaker 1: not done, of course, we can, as you know where
Speaker 1: working on improve versions and getting a full license for this.
Speaker 1: Would like to get it approved in Europe and other countries,
Speaker 1: but perhaps it's the end of the beginning for very
Speaker 1: effective treatments for newly diagnosed patients with stars code two.
Speaker 1: This is a scientific feat that those that Lily, those seller,
Speaker 1: those that the n i H are so excited about.
Speaker 1: It is a tool seen as a bridge to a
Speaker 1: vaccine to treat those at the early stages of their
Speaker 1: disease and prevent them from progressing to the hospitalized setting.
Speaker 1: So it's another thing to add to the toolkit of
Speaker 1: doctors who are looking to treat those with COVID nineteen,
Speaker 1: particularly in a moment where we are seeing global surges
Speaker 1: in cases. This green light is certainly good news. Challenges
Speaker 1: are not over yet. I mean, what would you say
Speaker 1: is the biggest hurdle that Lily is anticipating in say,
Speaker 1: the weeks or months to come. Lily is quite concerned
Speaker 1: about supply. I think the most notable thing out of
Speaker 1: this conversation with David Ricks was really that capacity. No
Speaker 1: matter how much manufacturing capacity they have, no matter how
Speaker 1: many deals they reach for additional firepower to boost supply,
Speaker 1: there simply is not going to be enough. The real
Speaker 1: challenge is about scale. I don't think we would have
Speaker 1: for difted back in April when we triggered the decision
Speaker 1: to start manufacturing at pretty big scale million doses this
Speaker 1: fall that we may need all of those. And then
Speaker 1: so it occurred to us, you know a few months
Speaker 1: later that might be true. And now we're in the
Speaker 1: middle of the surge and I think we did everything
Speaker 1: we could, but still it may not be enough. So
Speaker 1: we have to continue try to squeeze out as much
Speaker 1: supply as we can, and unfortunately that's not a quick
Speaker 1: turnaround time, but clearly we'll be needed. Um, it's really
Speaker 1: quite concerning to David Ricks. I'll have you know that
Speaker 1: within the first week they've shipped out eighty eight thousand
Speaker 1: doses of this antibody, but just consider the sheer number
Speaker 1: of cases on a daily basis. So with any new
Speaker 1: treatment for COVID nineteen, concerns are tied up with distribution.
Speaker 1: Who will be able or eligible to receive the new
Speaker 1: antibody therapy from Lily. The Food and Drug Administration has
Speaker 1: authorized the experimental treatment for use against mild to moderate
Speaker 1: COVID nineteen in adults, including those who are sixty five
Speaker 1: and older, as well as pediatric patients. Lily will supply
Speaker 1: the product, but the US and a distributing partner will
Speaker 1: determine how to allocate this product based on need, So
Speaker 1: where there are cases, it will proportionately be distributed to states, territories, municipalities, cities,
Speaker 1: and so forth. It will take a little bit of
Speaker 1: time for doctors to learn about this and start getting
Speaker 1: getting their own experience. But that's against the background of
Speaker 1: probably something like a million patients diagnosed with COVID nineteen
Speaker 1: this week in the United States. Amongst those million, we
Speaker 1: would estimate something like or high risk. So design enough
Speaker 1: supply to go around the US is going to have
Speaker 1: a challenging time at that sub level, at the local level,
Speaker 1: determining who is high risk within this camp, because the
Speaker 1: number of mild to moderate nineteen patients in this country
Speaker 1: is massive at this point in time as we see
Speaker 1: a US surge unfold. So Riley, you've already identified some
Speaker 1: serious challenges just on the US level, and Lily has
Speaker 1: agreed to supply the US with the initial three hundred
Speaker 1: thousand vials of the therapy, but there will be obvious
Speaker 1: global demand for this therapy. How is Lily going to
Speaker 1: meet that demand? This is a fascinating question because Lily
Speaker 1: is approaching the question of supply and demand very differently
Speaker 1: than we're seeing others who are developing both treatments and vaccines. Um,
Speaker 1: Lily did clinch this deal for three hundred thousand vials
Speaker 1: of the antibody treatment, but the U S has this
Speaker 1: option to purchase an additional six hundred and fifty thousand vials.
Speaker 1: Now you got to read the fine print in that,
Speaker 1: because those six fifty thou vials will only go to
Speaker 1: the US if Lily and the federal government determined that
Speaker 1: the need is high here and higher than elsewhere. We
Speaker 1: know we have more capacity. At the time we signed
Speaker 1: that deal, interested in making sure that there was access
Speaker 1: to this medicine no matter where the disease was. You know,
Speaker 1: it's raging in Europe as well. Of course, Europe hasn't
Speaker 1: approved the drug and they haven't contracted with US yet.
Speaker 1: So while that's the case, I think our ability to
Speaker 1: get more drug to the US will go up because
Speaker 1: they've got this option. But the option is a two
Speaker 1: way option, so that both parties need to agree. So
Speaker 1: it's an agreement to agree later, and it is currently
Speaker 1: designed to kick in two months after the initial emergency
Speaker 1: use of authorization. I'll tell you if if no other
Speaker 1: country approves this or contracts, then we'll be at liberty
Speaker 1: to just get more products to US patients who need it.
Speaker 1: If Europe approves this quickly and wants to contract again
Speaker 1: at the same race as the US we'll we'll shift
Speaker 1: product to them as well. There's of epidemic and particularly
Speaker 1: in France right now that it's very concerning. So um,
Speaker 1: you know, we want to get the product to where
Speaker 1: it's needed. Most many of the companies that have agreed
Speaker 1: to deals with Operation Warp Speed have agreed flat out
Speaker 1: here is a price that they receive for a dose. Right.
Speaker 1: But Lily with these vials, is saying you can have
Speaker 1: these vials if and only if there is significant need. Now,
Speaker 1: what Ricks did say is it's looking like there is
Speaker 1: going to be significant need here in the US as
Speaker 1: the pandemic surges on. But we'll we'll wait to see
Speaker 1: in the months to come whether it taps into that supply.
Speaker 1: So Riley, finally, how does Lily anticipate working with the
Speaker 1: Biden administration? Have the results of the election changed any
Speaker 1: of their plans? Rix made a fascinating point here, which
Speaker 1: is Operation Warp Speed is working eli Lillian Company and
Speaker 1: the broader drug industry is incredibly supportive and in fact
Speaker 1: applauds the work of the White House lead Operation Warp
Speaker 1: Speed effort. An important thing to note, however, is that
Speaker 1: Lily has not taken capital from Operation warp Speed for
Speaker 1: its R and D or its manufacturing. The deal it's
Speaker 1: clinched is for supply and supply alone. You might know
Speaker 1: the name Visor at this point and its partner by
Speaker 1: on Tech. They're in a similar camp. Those two companies
Speaker 1: did not take money for research and development or manufacturing capacity,
Speaker 1: but really just those doses. And that's quite novel. Again,
Speaker 1: it's different from those like Johnson and Johnson or Maderna
Speaker 1: or even Regeneration here in the antibody space that I've
Speaker 1: taken money for initial research. It was very important for
Speaker 1: Lily to have put down that risky investment from the
Speaker 1: get go, and we will see what liberties that will
Speaker 1: allow them moving forward both amid the pandemic in a
Speaker 1: post pandemic world. That was Riley Griffin. And that's it
Speaker 1: for our show today. For coverage of the outbreak from
Speaker 1: one and twenty bureaus around the world, visit Bloomberg dot
Speaker 1: com slash Coronavirus and if you like the show, please
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Speaker 1: are Spotify. It's the best way to help more listeners
Speaker 1: find our global reporting. The Prognosis Daily edition is produced
Speaker 1: by Topha foreheads Jordan Gospure, Magnus Henrickson, and me Laura Carlson.
Speaker 1: Today's main story was reported by Riley Griffin. Original music
Speaker 1: by Leo Sidrin. Our editors are Rick Shine and Francesco Levi.
Speaker 1: Francesco Levi is Bloomberg's head of podcasts. Thanks for listening
Speaker 1: to