BioTech races toward safe and effective COVID-19 vaccines

Since January, healthcare companies have raced to provide support against COVID-19, noting that vaccines may be the best (and perhaps only) way of stopping the virus.

This week, American biotech company Moderna announced its first successful test of a novel coronavirus vaccine, causing its stock to soar. Meanwhile, healthcare giants Abbvie, Catalent, BioNTech, Pfizer, and Merck presented at the UBS Global Healthcare Conference, outlining their approaches to developing safe and effective coronavirus vaccines before the end of 2020.

Despite Moderna’s early successes, experts agree that it is essential to develop multiple vaccines, as the global need for billions of doses will far outpace the production capacity of any one manufacturer.

AlphaSense can track FDA drug approvals in real-time using smart search technology. You can also track management commentary in real-time across the entire market, by industry, or watchlist. We expect that the coronavirus vaccine will be an essential theme to follow throughout 2020 and into 2021. Start your free trial of AlphaSense now or login to your account. 

 

Takeaways:

• Pfizer is testing four different variants of an mRNA vaccine, and is planning to have 8,000 total participants for the coronavirus vaccine this fall noting: “We’d be manufacturing the lead candidate. We’d be manufacturing at risk. We’d be in a position to have tens of millions of doses, if successful, this year and then hundreds of millions next year.”
• BioNTech and Pfizer are collaborating on the “rapid development and manufacturing of [their] vaccine candidate, mRNA-1273.”
• In their conference transcript, Moderna executives stated that they believe they are positioned to have the first (or one of the first) approved vaccines for COVID-19. For more information about Moderna’s Phase 1, read their latest company presentation “Novel Coronavirus Vaccine (mRNA – 1273) Positive Interim Phase 1 Data.”
• Catalent noted that, in total, they have been presented with more than 100 opportunities involving about 90 molecules, which represents ~45% of all COVID-19 products and treatments in development.
• Private company Immunoic spoke about creating a vaccine that “hits multiple targets on the virus, not just the spike protein” to generate a more robust response to the virus.
• Despite not launching its own vaccine program, Takeda Pharmaceuticals President & CEO Christophe Weber noted: The question will be how much risk the world wants to take by shortening the development period of the vaccines, which normally take 5 to 10 years. I mean, if you shorten to 1 to 2 years, you have less data.

 

Abbvie (UBS Global Healthcare Conference – 5/20)

Question – Navin Cyriac Jacob: Fully understand that this question maybe challenging to answer, given how early stage you are with this and how, on a relative basis, the understanding of the virus is extremely early in its existence. But is there — is the antiviral approach that we’ll be taking against SARS-CoV-2 will — do you think it will be a combination approach? I mean, so far, everything seems to be done on a monotherapy basis, perhaps combination, if you think about hydroxychloroquine plus ZITHROMAX. But typically, we see cocktails being created. And in HCV, we even had cocktails being created with multiple novel therapies that have not necessarily been approved. Is there a path for a novel cocktail of antiviral being pushed forward in development for SARS-CoV-2?

Answer – Michael E. Severino: Ultimately, I think combination therapy will be the answer to treatment of COVID infection. Obviously, vaccine development will also be important, but that’s a separate matter. If we talk about treatment of COVID infection — and I think there will be a need for both, a vaccine, certainly, but also the ability to treat patients who acquire disease either before a vaccine is developed or in the period between when a vaccine is first available and when we have wide-scale immunity across the population. There’s going to be a period there where antiviral therapy is going to be very, very important. And I do think combinations will ultimately be the way to go. I think in the initial studies, what you saw is monotherapy for the reason that I mentioned earlier, which is that we are primarily dealing at this stage with repurposed therapies that have unclear activity, and there was a desire to establish individually whether activity was or was not present.

Once that’s known, I think building up rational combinations would be very important. And as we have therapies that are specifically targeted for COVID, where one can have greater confidence that you would see the kind of inhibition of our replication that would take to translate into a clinical effect, I think building up combinations will be very important.

 

Catalent (UBS Global Healthcare Conference – 5/20)

Another point is given our capabilities as well as our organic and inorganic investments that we’ve made, Catalent has really become a go-to company for COVID-19 therapies and vaccines. We’ve engaged work across all 4 of our business segments, including projects for drug substance, drug product, oral, respiratory, analytical chemistry and then finally, clinical supply services. In total, we’ve been presented with more than 100 opportunities involving about 90 molecules across those opportunities. And that represents, we believe, somewhere around 45% of all COVID-19 products and treatments in development. We’ve signed around 30 deals, including a partnership with J&J for establishment of a new segregated manufacturing capacity in preparation for large-scale commercial manufacturing in the U.S. for their lead vaccine candidate in our Bloomington facility. We also had a press release regarding a partnership with Arcturus Therapeutics to support the drug substance manufacturing of its COVID-19 mRNA-based vaccine candidates in our Madison facility. 

 

Icon PLC (UBS Global Healthcare Conference – 5/20)

Question – Daniel Gregory Brennan: Okay. Well, before we go to virtual, since we have about a little under 20 minutes left, maybe I’ll skip back to virtual so we have time at the end. But maybe just kind of switching gears more towards the environment. I was wondering, can you quantify like what have you provided in terms of the impact — positive impact from COVID so far? How much has COVID trials contributed in 1Q? What are you seeing kind of what’s baked in Q2? And any way to frame the potential benefit as we play out in 2020 and possibly early 2021?

Answer – Brendan Brennan: Yes. I think it’s a solid environment in terms of what we’re seeing there from an RFP perspective, both COVID and non-COVID. Obviously, there’s a lot of activity going on here. As we know, there are hundreds of compounds in development, whether they’re treatments or vaccine candidates for COVID treatment. So — yes, and we’re very, very active in this space. I would want to kind of just caution a little bit here in terms of while there is a lot of activity here, and it will help because it’s obviously — these are vaccine trials and treatment trials, and we’re all racing towards, as I said, winter to ensure that we have treatments and vaccines in place. So it will help us during these — maybe these more fallow months of the summer period that we’re going through in Qs 2 and 3, particularly, probably more so in Q3 as those times, trials really start to ramp-up in terms of patient headcounts.

So I do see it as a help, although probably not substantial enough to really counteract any kind of imbalance as a result of the shutdown of sites.

 

BioNTech (UBS Global Healthcare Conference – 5/19)

So in addition to that, we’ve entered into other partnerships using a variety of models. I think Pfizer is a prominent one that you see there on the page. We first entered into a research collaboration. This is our first collaboration in the infectious disease space in 2018 to develop mRNA vaccines against flu. And more recently, we’ve expanded that collaboration to develop multiple COVID-19 vaccine candidates, which is currently ongoing in clinical trials. I’ll speak more about that in a few minutes.

…In addition, we have our first program in the clinic outside of oncology in the form of our COVID-19 vaccine program, it’s BNT162 you see on the page, where we’re partnered with Pfizer and Fosun. Pfizer worldwide ex China, Fosun in China. We are currently conducting clinical trials in Germany and in the United States and plan to also initiate trials in China. And this is a broad program for COVID-19, where we have 4 different candidates that we plan to study in the first phase and have an upcoming readout, which I’ll talk about a little bit more in this slide or 2. But we expect it in June-July time frame in terms of first human data.

… And then also, I’ll highlight that in addition to the BNT, the COVID-19 vaccine data, which we expect, as I said, in June or July, we also expect in the second half of the year first data for our bispecific antibody. This is a PD-L1 4-1BB. This is, again, partner with Genmab, 50-50. We see great potential in this molecule to potentially establish a new standard of care in certain solid tumors. In the preclinical setting, we’ve seen this molecule outperform first generation checkpoint inhibitors and are excited to present our first data in humans likely in the back end of the year.

 

Pfizer (UBS Global Healthcare Conference – 5/19)

Question – Randall S. Stanicky: Yes. And then if we pivot to what’s probably definitely not in Street models, you can look at COVID-19 therapy or vaccine. Obviously with Moderna’s update, a lot of focus around vaccines right now. But as we step back, there’s also a lot of focus on where Pfizer is at. And I think Albert was recently quoted as saying you guys could be in a position to deliver millions of vaccine doses of BN 162 (sic) [BNT162] by October. And so just in light of some of the news over the last couple of days, how are you guys thinking about COVID-19 from either a therapy or vaccine perspective?

Answer – Charles E. Triano: Yes. So we’ve got both. We’re in the clinic now with our partner, BioNTech, right? And so we’ve got an mRNA vaccine — and I’ll say plural, vaccines. We’re testing 4 different variants of an mRNA vaccine. So we’re testing not just the spike protein, which we are testing but we’re not just testing that. That’s Moderna’s approach, and I’m not saying that that’s a bad approach at all. But in addition, we’re testing both the spike and the receptor binding domain. So we — which offers a different hypothesis and allows us then to select based on clinical data, the best 1 or 2 hypotheses to move forward here, right?

So as we look at that, we are looking to dose just under 400 patients with each of the 4 variants of the vaccine. One is a self-amplifying version of that. We have 2 modified RNA and one with unmodified RNA. So we’re looking at those. And the plan would be as we move forward — and I expect we’ll probably be in a position — and we’ve got our partnership here, so I can’t commit to everything. But I would think by June sometime, we should be in a position to have some early antibody data there. And presuming that 1 or 2 of the programs starts to show itself and emerge as probably a best hypothesis, we’d look to move to sort of a stage 2 of testing where we’d get into now closer to 2,500 patients and continue to add on the database.

And so that would run really through the summertime. And then after that, again, presuming things continue to go well and we’re seeing a good profile emerge, we’ve said in the fall, we’d have probably close to 8,000 total participants on vaccine. We’d be manufacturing the lead candidate. We’d be manufacturing at risk. We’d be in a position to have tens of millions of doses, if successful, this year and then hundreds of millions next year. So really kind of growing the clinical study, reporting data maybe not quite real time, but more of a back and forth with the regulatory agencies in terms of, as we get data in, to supply them with data. And we can do a much, we think, quicker analysis of the data.

But I think our view having the 4 different variants of the mRNA vaccine, both the spike and the RBD, may be an advantage here as we look to move quickly toward a vaccination. We’ve got manufacturing capacity at our existing facilities there. So we’re very hopeful that 1 of the 4 programs will look good.

And then on antiviral, we have screened out a lead compound. We’ve had some antivirals in our library back from SARS. They had not been in preclinical tests at that point. But we had, with a third party, screened out and have looked to — looked and have identified a lead candidate that we’ll start looking at that. We’re also looking at Xeljanz. There’s a study going to occur in Italy with Xeljanz, looking if there may be some impact on the cytokine storm that we’re seeing as part of the ramifications of COVID-19.

So several irons in the fire here. Pfizer, in terms of decision-making and resource allocation, moving very, very quickly. And this is led from the top down, from the CEO level down, doing everything we can to, as safely and as quickly, look for vaccines or therapies here. So the company is moving very, very quickly. The whole leadership team and clinical development team, highly, highly focused here, which is what you need, right? You need a company, in not just Pfizer, but you need other companies, large companies that can make the investment, that have the resources in terms of clinical studies, manufacturing.

 

Syneos Health (UBS Global Healthcare Conference  – 5/19)

Question – Daniel Gregory Brennan: Excellent. Okay. And then on the flip side, obviously, there is the drag, but there’s also a potential nice opportunity given all the COVID research that’s ongoing. I know at the call, you discussed some color about the number of COVID trials that you’re involved with, both therapeutics and vaccines. What — how do you see that opportunity progressing? I know it’s only been a short time since the call, but maybe you could just kind of highlight Syneos’ position and kind of the future potential here.

Answer – Alistair Macdonald: Yes. Well, I think it’s an interesting space because it could be very short-lived, and let’s all hope it is, right? So we are — gosh, well, we’ve actually won another COVID program today, so I don’t know the exact number we’re up to now, but it was in the high teens before in terms of the overall number of projects. Now some of those are trials, vaccine trials, et cetera, but some of them are just consulting, engagements, et cetera. So it’s not all big trials. That will bring a faster piece of revenue through the organization, but it doesn’t offset the delays in all the other programs caused by COVID. So it’s not going to fill that hole. But we are engaged in it. I think as the world’s second-largest CRO, we’re always going to be in or around those kinds of requests when things are moving very quickly. So we’re doing our part in that sense. We have a great history and a great track record in infectious disease, vaccines, et cetera. So we’re well equipped to handle that.

 

Merck (UBS Global Healthcare Conference – 5/19)

Question – Navin Cyriac Jacob: You — Merck announced on the Q1 call that you have a vaccine program underway for COVID-19. There are various different vaccine modalities being explored. Just today, Moderna announced some Phase I data and some preclinical data. There’s a DNA approach. Merck is taking a more traditional approach. But wondering how you think about your approach relative to some of the more novel approaches. Roger on the call, on the Q1 call, highlighted perhaps a need for multiple different vaccines for COVID-19. When you guys think about the reason why multiple vaccines may be required, is that because of different baseline demographics? Or what is the thought process behind why multiple vaccines may be needed for COVID-19?

Answer – Michael T. Nally: Well, I think in many respects, Navin, when we’ve looked at this, right, one of the things that we’ve been very thoughtful about in our approach has been we really don’t understand this virus at all. And the virus was initially sequenced in kind of the mid-January time frame, right? And our understanding of the implications of the virus continue to evolve on a daily basis. We’ve all kind of seen the evolution around the cytokine storms, around clotting, around risk in children. We’ve also kind of had a — it’s taken us some time, and we’re still in somewhat the early days on understanding the fundamental transmission dynamics as well as durability of antibody protection. And so for us, and you’ve seen this in some of the announcements that we’ve made, we’re trying to understand the nature of this virus. We’ve got a partnership with the Institute of Systems Biology (sic) [Institute for Systems Biology] to really try and understand the nature of the virus to kind of ultimately formulate the best approach for both treatment and vaccination.

Question – Navin Cyriac Jacob: As — given the challenges of expanding coverage — or rather, capacity with GARDASIL, how do we — how do investors think about COVID vaccines? I mean Merck is one of the leaders in vaccine production and had obviously an existing franchise in GARDASIL and has had challenges expanding capacity there. Is this piece of vaccine production not fully appreciated by either Wall Street or general public as it relates to COVID vaccines?

Answer – Michael T. Nally: Well, I think you’re hitting on an important point, Navin. The — in our estimation, scale-up will be as profound a challenge as the science, right, to come up with a valid construct. Now the difference with some of the COVID platforms is there’s existing capacity that can be leveraged for those assets and also, the constructs may be more amenable to the existing facilities. The complexity of GARDASIL oftentimes comes in the fact that you’re really combining 9 different vaccines. The 9 different serotypes in GARDASIL 9 makes it a very complex construct. And in doing that, it’s far more complex than the constructs that we’ve seen to date for COVID. Usually, you’re talking a single antigen-based approach, leveraging an existing platform that can leverage existing capacity. I think what you’re going to see in the COVID response, the initial capacity build-out will leverage existing facilities. The — a lot of the challenges will come on the form fill side because this is a challenge across the industry. It will depend on whether or not lyophilization capacity is required. And depending upon which vaccines are successful, how do you quickly shift capacity because we’re going to need to band together across the spectrum, whether it be industry or CMOs, to try and support the most promising technologies going forward. But you also have — within the time line, in the GARDASIL time line, we’re moving at a breakneck pace. But even within that, things like permits and regulatory cycles are more traditionally-oriented. COVID will have, as we’ve seen with all the clinical work, unprecedented time lines on some of those things that can condense in these time lines a bit even as you’re building new capacity.

 

Moderna (UBS Global Healthcare Conference – 5/19)

Navin Cyriac Jacob, UBS Investment Bank, Research Division – Equity Research Analyst of Specialty Pharmaceuticals and Large Cap Pharmaceutic: Fantastic. Well, very eventful day for Moderna today and obviously, for the entire market as well. Very exciting news that you had to share with us today.

Perhaps for folks who haven’t seen all the data, wouldn’t have a chance to see or listen to your conference call this morning, Tal, if you don’t mind, one or two sentences just summarizing the data we’ve seen so far before I dig into some questions here around the data set for the SARS CoV-2 vaccine.

Tal Zaks, Moderna, Inc. – Chief Medical Officer: Sure, Navin, I’m happy to. So what we’ve announced today is the first positive interim results from the Phase I study that is still ongoing. In today’s announcement, we described data from the first 3 cohorts of subject aged 18 to 55 that were treated with 25 microgram, 100 microgram or 250 microgram in a prime boost regimen of our vaccine. The primary endpoint here is safety and tolerability as well as immunogenicity. And and at a very high level, what we described is as follows. On the safety and tolerability side, we see pretty much what we expect see. And this is a mixture of local and systemic solicited adverse reactions. The — there was no — nothing surprising here. It’s all the things that we’ve seen before and what one would expect from vaccines. There were no great (inaudible) adverse events. There were no serious adverse events. What was notable is that we had 3 cases of severe adverse events, but only in the 250 microgram at the top dose and only on the second dose. So on a CMO, so I always start with safety. Now the — I think the news that got everybody excited here is the immunogenicity. And what we’ve described is that at 25 micrograms already, we are seeing, after a boost, subjects have antibody levels in their blood that are at or above what we typically see in convalescent serum. In fact, they exceed the median point or the halfway point for people in terms of the antibody levels and people who are recovering from COVID-19 disease.

At the 100 microgram, we see, after the boost, clearly a level that is far above that with non overlapping confidence intervals, and so we see a very nice dose response curve across the cohorts. We don’t yet have data for the post-dose 2 for 250, just so we didn’t go into any depth in there. But it’s pretty clear that the prime boost and across the doses, we’re seeing very nice immunogenicity. Now the salient point that I think everybody has been waiting for is not just describing the level of antibodies, but assuring ourselves and the world that these antibodies are what you’d expect in terms of their activity. That’s been done with assessing their ability to neutralize the virus. 

 

Moderna  (S3ASR – 5/18)

Our Vaccine Candidate Against SARS-COV-2 (mRNA-1273): In response to the global coronavirus pandemic, we are pursuing the rapid development and manufacture of our vaccine candidate, mRNA-1273, for the treatment of SARS-CoV-2, the novel strain of coronavirus that causes COVID-19, in collaboration with the Vaccine Research Center and Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). 

… We believe we are positioned to have the first or one of the first approved vaccines for COVID-19, which will give us an opportunity to have a global health impact.

 

Moderna (Press Release – 5/18)

Biotechnology company Moderna reported on Monday that study subjects who received its COVID-19 vaccine had positive early results.

Reportedly, all eight initial participants in the Moderna trial developed neutralising antibodies to the virus at levels reaching or exceeding those seen in people who have naturally recovered from COVID-19, the press release stated. Moderna has partnered with the National Institutes of Health to develop the vaccine.

This early data comes from a phase 1 clinical trial, which typically studies a small number of people and focusses on whether a vaccine is safe. The information has not been peer reviewed, nor published in a medical journal.

Dr. Tal Zaks, chief medical officer at Moderna, was quoted as saying: “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 ?g.”

At the highest dose, three participants had the most notable adverse events, which were resolved and no serious adverse events were reported, Moderna said, but did not specify what the adverse events were.

According to the World Health Organisation, Moderna is one of eight developers worldwide already doing human clinical trials of potential vaccines against the novel coronavirus. Two others, Pfizer and Inovio, are also in the US, one is at the University of Oxford in the UK, and three others are in China.

 

AGC (Earnings Call Transcript – 5/18) 

In life science business, we are receiving a contract for development and manufacturing of vaccine as well as treatment of COVID-19. We have already signed a contract for one treatment and one vaccine, and there are multiple deals that are currently ongoing.

 

BioNTech (Bank of America Merrill Lynch Healthcare Conference – 5/14)

And finally, our business model is built around an industry-leading set of collaborations. And these collaborations help us accelerate our own pipeline products towards the market and have also brought us supporting capabilities for technologies, which complement our own pipeline.

You see some examples of these collaborations on Page 5. In the oncology space, they tended to be cost and profit shares, 50-50 model. It’s a model we’ve implemented multiple times here, both with Roche, Genentech, with Genmab, similar model with Sanofi and also more recently with Pfizer in the case of our COVID-19 vaccines.

…And last but not least, our BNT162, our COVID-19 vaccine. As indicated earlier this week, our quarterly — first quarter update call, we do expect our first-in-human data in the June/July timeframe. So now I’ll say a few words about our mRNA cancer vaccines, FixVac and iNeST.

So turning to COVID-19. I’ll spend just a few minutes on COVID-19 because I think, this has been covered quite a lot in many recent calls. But for those of you who are less familiar with our program, and I’ll start by saying that we made the decision in late January, when we saw the news coming out of China, to move into COVID-19 because we thought that our vaccines and our technology could make a difference here. And we thought we had the ability to move very quickly. And indeed, I think, we were able to do that going from concept to start of clinical trials in about 3 months.

So why is mRNA well suited for pandemic vaccines? Well, there’s a couple of key reasons. First of all, I’ll remind you that mRNA is a naturally occurring genetic molecule with defined — well-defined biochemical properties. It’s of high purity and it’s an animal free product, and we’ve shown it in the case of the cancer vaccines, but also others have shown that it’s highly immunogenic and does not require the need for an additional adjuvant. It’s one of the advantages versus some other modalities. We’ve shown and certainly seen in our own studies, that an mRNA-based vaccine has the ability to stimulate both strong antibody and T cell immune responses at very low doses.

And since starting clinical testing with mRNA vaccines in 2013, we have dosed more than 400 patients, in this case, very sick patients, typically, with doses, ranging up to 400 micrograms, which is well beyond what we’re testing here in the COVID-19 scenario. And last but not least, the mRNA, as a modality, enables highly scalable production processes and actually relatively low-cost production as well, at large batch sizes, which make the ability to manufacture hundreds of millions of doses possible.

 

Catalent (Press Release – 5/14) 

PARTNERING FOR TREATMENTS: We are working with several customers on multiple COVID-related antivirals, vaccines, diagnostics and treatments for symptoms and effects of the Covid-19, including Johnson & Johnson’s lead vaccine candidate, Arcturus Therapeutics’ mRNA-based vaccine, Humanigen’s GM-CSF monoclonal antibody, and Ennaid Therapeutics’ antiviral treatment targeted at COVID-19.

 

Immunomic (Press Release – 5/14)

While ITI is intent on progressing its ITI-1000 program into Phase III trials and advancing other promising product candidates along its pipeline, including a cell-free version of the glioblastoma therapy called ITI-1001, it is simultaneously deploying the UNITE technology to develop a COVID-19 vaccine.

In the past, the UNITE platform has been widely applied to create vaccine candidates for rabies, yellow fever, Dengue fever, hepatitis C and another coronavirus, SARS, so Hearl and his team felt confident that their platform could help solve the COVID-19 problem. ITI has partnered with Epivax to develop the design for the vaccine and Pharmajet to deliver the COVID-19 vaccine via its needle-free injection technology if the vaccine is approved.

‘For COVID-19 we can hit multiple targets on the virus, not just the spike protein. We can pull these together and create a vaccine design that will generate a better, more robust response,’ said Hearl.

‘We have materials prepared and are conducting mouse experiments. Once we have proof of concept in an animal model we can really start looking at human safety studies for our COVID-19 vaccine hopefully later this year,’ he added.

 

Takeda Pharmaceuticals (Earnings Call Transcript – 5/13)

Question – Fumiyoshi Sakai: I have one question, well, specifically right here. I think this is a question for Weber-san from your expertise. Where do you stand with the COVID-19 vaccine development? Now some companies are very hopeful about commercializing the vaccine within a very short time — period of time. But I really doubt a vaccine is going to be developed so easily. It takes time, and every company is now working in different standard. I know there’s some experts saying we need the vaccine to be effectively defense — defend the infection. But obviously, we are — I’m stopping there — where are we going to go? So I appreciate your input on this. Obviously, some input from Plump-san as well.

Answer – Christophe Weber: Thank you very much, Sakai-san. So I mean, my view is that it’s good to have multiple technology progressing in parallel because it would be too risky for the world to bet only on one technology. So to have 4 or 5 technologies is great. And you see what we have today with the RNA vaccines, adenovirus vaccines and more of the traditional type of technology.

There is — we shouldn’t have too many because you have — you will waste resource if you have like 50 candidates. I think it’s a waste of resource. But it’s — perhaps what we will get — I think that we shouldn’t forget that developing vaccines is very hard. Some vaccines will have no efficacy. Some vaccines will have an efficacy which will wane over time. And sometimes, we need a booster or — and some vaccines will have 50-50 signals as well potentially. So the world think — might think that it’s a slamdunk, the vaccines will come. But it’s far from sure.

I’m optimistic that a few will succeed. The question will be how much risk the world wants to take by shortening the development period of the vaccines, which normally take 5 to 10 years. I mean, if you shorten to 1 to 2 years, you have less data. And therefore, we’ll need to see how we assess that.

And then the last point I will make is that the big issue is the manufacturing scaling. And so scaling the production of vaccines is not easy. Usually, it takes time. And a bottleneck are not necessarily where you anticipate them. So one of the well-known bottleneck in the industry is actually the syringe and the filling of the syringe, which is more late-stage downstream manufacturing process, but that’s a huge bottleneck.

Another bottleneck which is huge in the world today is the lyophilization process. For example, because there is a scarcity of big lyophilizators. So I think that we should be careful at managing expectations. Not all vaccines will succeed. There will be some bad news, some good news as well. I think a few will succeed. And then the scale-up will take time. The scale-up will take time.

And so if you are looking at successful vaccines and we vaccinate the majority of the population worldwide, you are talking about 5 to 10 years.

Question – Fumiyoshi Sakai: That’s really long. But any program of Takeda for any specific project right now ongoing?

Answer – Christophe Weber: Yes. So in fact, when we see the coronavirus back in December, January, we assessed if we should have our own programs. But we didn’t have the best technology to launch our own programs. So we didn’t launch our own vaccines programs. But we are keen to partner, and we are in dialogue with a few vaccines manufacturers, 2 vaccines company and programs to be a partner so that we can help with the scaling up.

 

Corning (Conference Transcript – 5/13)

Question – Samik Chatterjee: Got it. If I can finish off with a question, just in the time that we have left on Life Sciences now. It still is a small portion of you revenue. But probably one of the areas that (inaudible) very well maintained benefit and kind of leverage some of the growth coming out of this COVID kind of pandemic, help us think about where you are in the process of getting Valor more widely distributed? What else do you need to do to ramp that outside of just production? What do you need to do in the channel, et cetera, to ramp that up more?

Answer – Wendell P. Weeks: I would say this current challenge has actually pointed out some of the weaknesses in the industry that we built Valor to address. So like I said, assuming we get a vaccine or we even get really good strong antiviral treatments. If you look at the capacity in the world, even before the COVID-19 issue, you are about 2 billion doses short of what the world needs in fill capacity and a pharmaceutical packaging. So we developed Valor because it increases the throughput of that fill capacity. And all fill capacity is assuming we invent a good COVID-19 vaccine, we’ve actually got to put it in a pharmaceutical package and then ship it out. If Valor increases the throughput by over 50%, so our existing fill capacity, now all of a sudden goes up dramatically. And if you invest in new fill capacity, we can get like a 100% improvement in throughput once you design around our new package. And it’s a lot safer for patients. The way Valor works is that it’s really — it overcomes one of the issues with borosilicate packaging cause you can have throughput of through cracks that create sterility problems. You can have glass flakes, you have all these sets of issues that endanger patients. And Valor is aimed at addressing all those pieces to be able to deliver things like COVID-19 vaccine cost effectively and safer. 

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