DBV Technologies SA at Bank of America Merrill Lynch Healthcare Conference
May 16, 2018 PM UTC
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DBV.PA - DBV Technologies SA
DBV Technologies SA at Bank of America Merrill Lynch Healthcare Conference
May 16, 2018 / 04:20PM GMT
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Corporate Participants
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* Charles Ruban
DBV Technologies S.A. - COO
* Susanna Mesa
DBV Technologies S.A. - Chief Business Officer
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Conference Call Participants
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* Tazeen Ahmad
BofA Merrill Lynch, Research Division - VP
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Presentation
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [1]
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Bank of America Merrill Lynch. It's my pleasure to introduce our next presenting company, DBV Technologies. Presenting for DBV this morning is Charles Ruban, Chief Operating Officer. Also sitting next to me is Susanna Mesa, who's Chief Strategy Officer.
We wanted to have this be very informal, so Q&A. If there's any questions from the audience, feel free to let us know. Otherwise, we will talk about topics that we've been getting questions on.
So Charles, you've had a few updates for your lead program peanut allergy. For those in the audience who may not fully the story, maybe you can talk for about 2 minutes about DBV, your platform, your latest catalysts. And then we'll go from there.
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Charles Ruban, DBV Technologies S.A. - COO [2]
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Thank you, Tazeen. Thanks for having us. Thanks, to everyone, really, for being around and listening.
So DBV Technology is, as you know, a company totally devoted to developing solution allergen immunotherapy solution directed to food allergies. We've developed, over the last 15 years, a very unique approach to treat those kind of disease through the skin and leveraging the skin immune capabilities.
We are very advanced in our food allergy program, especially with a first program, which is the peanut program. The platform is Viaskin, so the first program is Viaskin Peanut. We are -- we have completed the Phase III program so far, and we are excited about contemplating the next stage, which is filing the BLA to the FDA.
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Questions and Answers
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [1]
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So you did give us an update not too long ago that the application will move forward in the second half of the year. So a couple of questions that we have gotten is what needs to be done between now and when you file in the second half of the year?
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Charles Ruban, DBV Technologies S.A. - COO [2]
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Sure. So globally, as I was saying, basically, the -- you -- we are focusing this application on the first indication of the 4 to 11 years old children. That's where our, I would say, our clinical development program is actually, I would say, very comprehensive. And we have accompanying data from Phase III, and especially to Phase III -- from Phase II and 2 additional Phase III, REALISE and PEPITES, that have been completed. We checked with the FDA recently through a pre-BLA meeting that this -- the body of clinical evidence was actually sufficient to go for filing. This happened in February of this year. And right now, we are basically preparing the file, which is a very, I would say, heavy file, obviously, as you can imagine, on the medical side, but also on the CMC side. So that we are able to kind of file this dossier by the end of the year.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [3]
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And so as we think about between now and year-end, once you file the application, what are the timelines for FDA to give you feedback if they accept the application? And then beyond that, what are your thoughts on the potential for an outcome?
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Charles Ruban, DBV Technologies S.A. - COO [4]
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Sure. So I think if we -- so far, we, as you may know, we have this Breakthrough Therapy status that was granted back on the Phase II data by FDA. So the Breakthrough Therapy status is a nice thing because it really enables a very, I would say, continuous and easy communication with the FDA so that we get a profound and deep understanding of what exactly is expected. We are -- and this Breakthrough Therapy status also open for a potential accelerated approval for the accelerated filing. So meaning that, once we've -- I'm sorry?
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [5]
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Priority review (inaudible). Priority Review.
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Charles Ruban, DBV Technologies S.A. - COO [6]
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Priority review. Thank you, Susanna, for helping here. So the priority review, basically, which will -- we might be able to ask for at the time of filing. So the standard process is once you file your data, you have a 60 days acceptance lead time. Once you have filed is accepted, then actually, you can go on the next stage of the re-evaluation of the file. If it is a priority review, then actually, the evaluation lasts 6 months. So we don't know yet. We'll probably be asking for that. Your second question, as far as an advisory committee, will be -- is -- will be in the process, we are planning for, and we get already feedback from the FDA. And from what we have understood, for other application, that it is highly probable that, that we'll have an advisory committee. This is totally normal, right? We are talking about a new therapeutical area, and for which, obviously, FDA will act -- will want to get the feedback of all the stakeholders to understand and to drive, I would say, the application process.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [7]
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So maybe a question for Susanna. We've talked in the past about the Phase III data and the discussions you've had with the agency about the lower-bound interval. So for those who might not be familiar, can you just walk us through the importance of that in the discussions that you've had with FDA? What that means really in a real-world setting? And how you think the agency will feel comfortable with the results that you've shown so far?
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [8]
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Sure. So just for those that are not familiar, our Statistical Analysis Plan included a common consideration for CBER drugs and is actually not just showing that there's a statistical significant benefit, but that there's also some confidence interval considerations that you must meet. In our Statistical Analysis Plan, we included a 15% lower bound of the confidence interval, which needed to be met at the 15% difference between active and placebo. And we had a 12.4%. However though, and I think what encourages us in terms of the path forward, is that this confidence interval was something that the CBER division created to show that there's a differentiation between active and placebo. Obviously, we're showing that. And I think the 15% was somewhat of a random number that we chose based on the Phase II data. And it's important, and I think it'll be important as we go forward, but it's not necessarily something that you can correlate exactly with the clinical relevance of the product in real life. And I think what's important, from our drug development process over the last 10 years, is that we've shown consistently the same treatment effect over time, both from the safety and tolerability standpoint, but also from the efficacy standpoint. And in our Phase III trial, we were able to replicate the same -- somewhat the same response rate that we saw in our Phase II trial. And so I think it's certainly an interesting and important consideration from the technical and from the statistics standpoint, but we believe that it's something that will not necessarily mean that the product will be successful in real life. And I think what we rely on to look at those, that medical relevance and that medical value, it's looking at the benefit from patients over time. And the fact that this is a long-term immunotherapy and we're picking an arbitrary 12-months analysis of our data, but what we're showing is a highly statistical significant benefit. We're showing that, on average, patients, after having a baseline of roughly 2/3 of a peanut, by the end of the trial, they're roughly consuming 4 peanuts. So I think we're really showing that it's a progressive therapy. And FDA has shown in the past, in other CBER drugs, and specifically in the allergenic division, that they can be flexible with the CI. So we do have precedent out there showing that CI considerations can sometimes be changed during the review process. And so far, we feel enthusiastic about our interactions with FDA and obviously believe that the totality of the data will show that it's a very clinically relevant product. But it is something that we have to acknowledge. And I think from what we're doing to prepare as we go forward and as we possibly go into an ADCOM, is to continue to build our clinical evidence to show that this product is something that, from the risk/benefit standpoint, can be life-changing to many patients that are currently underserved.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [9]
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And so as you think about forward discussions with the agency, we just talked to Charles about the potential of an ADCOM, what would you think would be the topics that the committee would focus on at such a session, if you were to have one?
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [10]
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In the advisory committee?
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [11]
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Yes.
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [12]
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I think it's always dangerous to speculate when it comes to FDA conversations. But I think our view and part of the reason of why we feel so enthusiastic about our path forward is because we believe what's going to be very important in this disease is to show a good risk/benefit profile. And specifically, as we think about what peanut-allergic patients experience on a daily basis, they have significant burdens, right? I mean, these are patients that have societal challenges because they can't avoid peanut. Sometimes, they can be malnourished because they're not -- they're afraid of eating. So there is a very high burden for the parent and the child or the caretaker. And -- but when we think about the risk of these patients, we know that exposure to peanut happens anywhere between 15% to 40% on a yearly basis. And in fact, when you look the possible severe actions that these patients may have to peanut, they don't really have severe actions often. I think the literature shows that maybe every 2 years is when they could potentially experience a life-threatening reaction. And so what's really important for a product in this field is to show that you are desensitizing those patients, you are providing them additional benefit, however though, you're not compromising the safety. And I think Viaskin, because of the mechanism of action, where we've leveraged and used the powerful immune tolerance that can be created by the skin, and by doing that, we can keep a very small dose. I mean, for those of you that don't know about our trials, we use 250-microgram dose to desensitize patients, which is 1/1,000 of a peanut. And so we can offer patients a safe desensitization, and that fits well, we believe, with the need today, which is desensitization, but not at the risk of creating more damage than the actual treatment. And I think that's something that we're very proud of and it's something that we were able to create and develop these programs around Viaskin. And I think, from our standpoint, the data shows that this new and novel mechanism of action can do that: Provide a risk/benefit profile that will be very differentiated if the product is approved.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [13]
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Okay, thank for that, Susanna. So taking that last thought and applying it to your plans for commercialization. So Charles, you're kind of heading up that whole process.
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Charles Ruban, DBV Technologies S.A. - COO [14]
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Sure.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [15]
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Can you give us an idea of what you're spending most of your time on the commercial front during these days?
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Charles Ruban, DBV Technologies S.A. - COO [16]
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So I think we are spending a lot of our time, first, on really continuing understanding that market. And secondly, really shaping, I would say, it. Understanding the market, I think, in alongside -- along with Susanna said, we really now understand that, actually, it's a 3-player game, right? There is the patient; there is the caregiver, very important; and there is the doctor. As said, I think you have to think about those patients and the way, basically, to segment themselves as being diagnosed very early in their life. At around 2 to 3 years old, they have experienced a reaction through an accidental exposure. They hate peanut, they don't want to eat peanut. They've tried, they've been trained to kind of avoid peanut all the time. As a consequence, they have very poor quality of life. They are -- they tend to be bullied a little bit, as called, tend to be isolated. And what they are looking for is this additional level of protection in case of accidental exposure to peanut. And this is confirmed again and again through market research.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [17]
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It's probably also important to note that there's really no market yet. You'd potentially be one of the first to create a market.
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Charles Ruban, DBV Technologies S.A. - COO [18]
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Exactly. So that's probably the market-shaping side of it, which is very much in line with really understanding what exactly this -- the patient and the caregiver are living. Because I think from very early on, I think what I'd like to stress is that -- DBV has been extremely patient-centric in the way we have designed our approach and the way we have designed our patch and the way we have designed our understanding of those patients. We believe that those patients need an additional protection against accidental exposure to peanut, which is actually confirmed. They need to do that in a very safe manner and in a very easy manner. So I think that's why we basically put a lot of effort to simplifying as much, as we could, the treatment. It's a 1 single patch. It's a visible one. One dose. Very easy to apply. And actually, our clinical data really show that those patients are extremely compliant with the drug, the safety profile is important, and it really meets their need. Their need being to get a gradual protection without any disruption to their daily life. So I think the question about the disruption to the daily life is extremely important. It's important for the child. It's important for the mother, which usually, in 70% of the cases, she is working, she's not at home. And it is very important for the doctor, too, right? And those doctor are, we're talking about allergists. They have very organized and well-run practices. Everything -- they want to bring an additional value to those patient without disrupting their current practice. So that's basically the way understand the market today, and we feel like what we are trying to offer really fits very much into those constraints.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [19]
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And so can you talk about some of the -- well, I guess, the practicalities of using a patch. How does it work? And for example, do you have to go to the doctor frequently? Is there a titration period? All of that.
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Charles Ruban, DBV Technologies S.A. - COO [20]
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Yes. I think that's -- we've been really trying to understand what is the patient flow, where are those patient diagnosed and how they will be treated. And from the very first interaction with the allergist, and so at the first -- we believe that it's an allergy immunotherapy product, so the allergist will be taking over the treatment for the -- for this patient. Those patient will have to apply this patch, possibly at the doctor's office for the first visit. That's what happens with other therapies. And there is definitely a kind of training on how to apply the patch that needs to happen. There is -- the titration mode is actually very elegant because you're basically using the same patch, the same dose, instead of what you do in traditional allergy immunotherapies, actually, you increase the dose with different doses of product along very, very long durations, 6 to 9 months. Here, with the patch, you titrate only on a 3 weeks period using the same dose, but just playing on the duration of application. So the first week, you apply the patch for 6 hours. The second week, for 12 hours. And the third week, you're already in the, what I would say, the standard regimen.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [21]
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And how does it work with the supply of the patches? How many do you have at any given time?
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Charles Ruban, DBV Technologies S.A. - COO [22]
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So globally, I mean, we were still working on how many patches you would have at a given time. But I mean, the really standard package will be 30 days of patches that will be actually renewed. This is a product that we want to be really widely, I would say, available. So it's going to be a pharmacy-available, in, really, a retail pharmacies, so that we can make it very easy and very accessible. The patient then actually would be titrated at home very simply. He would have some monitoring visits, I would say, for 4 monitorings in the first year and 2 in the following years. And the monitoring of the patient will actually be done through the biomarkers that we're actually currently developing so that to follow the progression of the desensitization. So it's a very easy process for those patient. You have to understand that those patient can still exercise, get a viral infection and the data that we have today, in our pivotal trial, really show that there is no downside in being treated with the treatment today, which is actually, when we think about the market, a very differentiating feature of our product. Any product that really kind of limits the -- I would say, the daily activities of the kid or the mom or the allergist itself is something that will have difficult time, actually, to spread in the market.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [23]
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And Charles, can you just remind us what the safety profile looks like? What are the most commonly occurring events?
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Charles Ruban, DBV Technologies S.A. - COO [24]
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Sure. So basically, that's a patch. So it's applied on the skin. So what you should expect is to have a local reaction on the skin, which you have in, I would say, the majority of patient. Those reaction are itchiness, redness. And they tend to decrease with the additional duration of the patch, I would say, end of 3 months, you already see a significant decrease of those -- of these reaction. You never have any severe anaphylaxis. We never see it. Over the -- I think we have exposed more than 1,000 patients, And including peanut and milk, and milk is going to be a super-interesting thing because you see that, in milk, is a very, very severe allergy. And we see that, even with these allergy use, the patch really provides a very good safety profile. You don't have -- we haven't seen any severe anaphylaxis with either of the patch, which is the major, actually, reaction, what you're trying to prevent, right? It is extremely, extremely important. This is due to 2 things, actually. This is due to, first, the dose. I think Susanna really well stressed the fact that we are exposing to patient -- the patient on a daily dose to 0.001 of a peanut, right? And the first reactive dose of the patient is 1 milligram, it's 0.03 of a peanut. So it's really below even the lowest dose to which a patient will react to through oral ingestion. The second is actually not going oral, you're going through the skin. And the skin is a very efficient barrier, protection barrier. And then you're preventing, this way, the allergen to go in the bloodstream. And so that you don't have, you don't elicit severe anaphylactic reaction. So the profile of -- the safety profile of the drug is very strong, we believe, providing a good benefit/risk ratio. We are seeing reaction decreasing. And we are seeing patient being extremely compliant. We have 96% -- or 95%, 96% compliance rate in Phase III clinical trial, which is, I believe, totally unprecedented in that kind of -- in any form of allergy immunotherapy.
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [25]
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Yes. And I think I would add that, that profile, I think, as well captured also not just by the compliance rate, but over the last 5 years, including from our Phase I/II or both of our Phase III programs, our dropout related to treatment has been around 1%. So we do see that the safety and tolerability is something that's being reflected by the patients staying in our trials. They are compliant, and I think it speaks to the simplicity, but also to the potential of really using this as a first-in-class immunotherapy with a very unique proposal to the patient.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [26]
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And so Susanna, we spent most of our time talking about peanuts, but you are a platform company, you've got a lot going on. Can you give the audience a sense of what other programs DBV is currently in or thinking about going into?
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [27]
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Sure. So our main focus today is really food allergies. It's where we're spending most of our resources today. Obviously, we continue to expand our food allergies platform. And we actually have, in addition to peanut, we have Viaskin Milk, which just completed a Phase II program. And we've identified the right dose to move into the next steps of clinical development. So we're very excited, and I think Charles hinted at it, milk allergy is actually an extremely unmet medical need, in part because the exposure to milk is so high. Milk is very difficult to avoid. These patients tend to be very young, and so you do see more severe reactions. It's actually the #1 cause of food-related death in the U.K. It's the second cause of food-related death in the U.S. And over the last 25 years, there's been a lot of effort in milk. We've seen oral immunotherapy, we've seen sublingual immunotherapy. And there's always a challenge in optimizing the milk protein. Different than peanut, which tends to be a very soluble protein, milk actually has 2 components, it has a soluble component and it has a nonsoluble component. And it's actually difficult to optimize that absorption. And what we were able to do with Viaskin is actually find a very nice way to formulate that protein and put it onto the patch as a 300-microgram dose and expose the patients through the skin and create a significant desensitization over time. So we do have that data today, and I think we intend to speak -- we'll have our end of Phase II meeting with the FDA and EMA later this year. So that's our second program. We do also have a third program ongoing, it's for egg allergy. That's in for clinical. So we're still doing a little bit of work in trying to understand exactly what the commercial potential is, and most importantly, how do you design an egg trial. It is an interesting disease because a lot of patients do overcome egg. So we need to understand, from the commercial standpoint, exactly how we're going to address and what exactly are we addressing. And in addition to that, we have spent some resources in trying to elaborate on our mechanism of action and understanding what is the uniqueness of activating the immune system in the skin. And actually, we've had about 4 different preclinical programs that show promising data in areas such as Hemophilia A. We also had some program -- and a preclinical program with -- partnered with Mount Sinai in Crohn's Disease that shows significant reduction in inflammation of the esophagus. And the most advanced out of the food allergy platform program that we have actually is in eosinophilic esophagitis, where we're trying to reduce the inflammation of the esophagus by using Viaskin Milk. And that's actually partnered with CHOP in Pennsylvania, the Children's Hospital of Pennsylvania. And we should be seeing results from that Phase II trial. Phase IIa, so it's very mechanistic in nature, so I don't expect that we'll see anything -- from the efficacy standpoint, it shouldn't be something that will decide on how we move next. I think what we wanted to see from that trial, it's really the fact that there's a way to activate the gut, the esophagus and other parts of the body with the skin. So I think it's an exciting, I would say, 12 months for us. And we're really looking forward to move on in some of these other programs. Obviously, most of our resources are being spent on our peanut and milk programs today. But I think we have a lot to do. And with our Chief Scientific Officer, Tazeen, who you know well, Dr. Hugh Sampson, who's one of the most well-known immunologists in the world, and actually, the leader for that in food allergies, we're really excited in driving forward the other programs in the next 12 months.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [28]
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So you talk -- going back to milk. You talked about having upcoming end of Phase II meeting with the FDA. So does that mean that your next study will be your pivotal?
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Susanna Mesa, DBV Technologies S.A. - Chief Business Officer [29]
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I think it's probably a little bit hard to speculate. We did have a dose-finding study, so it was a 3 doses versus placebo. And it was a small sample size. So it's a little bit smaller than our Phase II program for Peanut. And I mean, look, I think it's an unmet medical need with an urgency to treat the disease today. And so I'm hopeful that we'll have good discussions with the agency. So far, they've actually been very, I would say, open for us to find ways to expedite our clinical development. I'll give you an example, something that we didn't bring up is actually that we do have, in addition to our Peanut program today in 4 to 11 years of age, we recently initiated -- or not recently, but about a year ago, initiated -- not a year, I'm sorry. 6 months ago, initiated a program in 1 to 3 years of age. And that's actually a Phase III program. And we've never tested Viaskin Peanut in patients 1 to 3 years of age, but the FDA, given that they've seen the amount of data that they've seen to date from us, and specifically from the safety standpoint, gave us a green light to move straight into a Phase III with this new patient population, which is very important for us. So I think we'll see what -- you know me well and I don't like overpromising, so I think we'll wait until we have that end of Phase II meeting to provide further guidance on next steps for our milk program. But again, I think if we look at the past, in our interactions with the agency, they have been supportive of our clinical development and finding ones to expedite, how to get treatments in this disease to patients because this area has been underserved for several decades, and it's the first time that, I think, we have exciting companies working in the space.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [30]
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Okay. And maybe to wrap up, we'll ask Charles for a couple of more bits of insight on the commercial front. So how of a commercial organization do you think you'll need once you go commercial with Viaskin Peanut?
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Charles Ruban, DBV Technologies S.A. - COO [31]
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So the great thing about the food allergy market is, actually, it's a huge market. We are looking, in the 1 to 11 years old patient, close to 1 million patients, so it's very significant. And as I was saying, it's really great to see such enthusiasm, so many initiative really trying to, really, to tackle food allergy. But at the same time, it is -- we're talking about really targeting the primary physician, which are allergists. Allergists are around a bit less than 4,000 -- 5,000 allergists in the field in the U.S. And to address that well, that population, actually, we would need between 50 to 100 reps, together with an additional MSL team that actually we are building up right now, which is actually very active on the field right now.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [32]
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And what are they doing right now?
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Charles Ruban, DBV Technologies S.A. - COO [33]
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So they are usually doing a lot of medical education, obviously. This has been and kind of left-aside field, right? I mean, those allergists have been extremely, I would say, active on respiratory allergen, obviously. They want to develop -- they are keen to actually develop the knowledge about food allergy because they are seeing more and more patient coming to their visit -- to their practice, and they're trying to understand what exactly the medical need is, what other current therapy in development right now. There is a lot of activity, a lot of publication coming in. And they are extremely eager to actually meet us. And we have -- we are developing a very well-trained MSL team right now, and they are engaging with the community very significantly.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [34]
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And so what is the profile of a sales rep that you would think would be good for marketing a new category?
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Charles Ruban, DBV Technologies S.A. - COO [35]
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So I think that's a very important question. I think as -- basically, we would like our sales rep, like any kind of, I would say, field representative of DBV, to behave like -- to be very consistent with what DBV is. DBV is an extremely patient-centric, high-science and trustable company. I think that's exactly what we want to convey in terms of image, and I would say, of value. So we will be bringing up people that are actually coming -- there's going to be a big mix, a good mix between, obviously, big pharma people, but also the biotech, more of the biotechnology world that -- because we are this kind of very specific animal, I would say, at DBV. We are a very high-tech company marketing a drug for which there is a huge patient demand. So we -- I would say the panel of skills that we would need, actually, it's a good combination between biotech and pharma.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [36]
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Okay, perfect. Any questions from the audience?
Okay, one last one from me. So if you were to think about penetration opportunity into the addressable market, there's plenty of children with peanut allergy, but there's varying degrees of seriousness of the allergy. And so as you do your market data research, what do you think is the best initial population that would be receptive to this type of treatment?
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Charles Ruban, DBV Technologies S.A. - COO [37]
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That's an extremely good question. We have been studying this market for over the last 3 years. And to be frank, there is no specific, I would say, medical profile as to really to be really the food allergy patient who will be more prominent to be treated by Viaskin, especially. It's basically a question of motivation of the patient. And there, we have a range of patient today, some of them are extremely concerned about their food allergy, the quality of life, extremely, extremely poor. Some other -- at the other end of the spectrum have been able to really cope with food allergies so far. I would say that the majority of them are considering that, I would say, avoidance is not enough. So I think -- back to your question, that, actually, you're building a success based on the patient that are the most motivated, and there are a big chunk of them. So that we -- you basically create the best positive experience with the patch. It's a long treatment. You basically also create a positive experience for the allergist. And then progressively, you're able to expand your market towards population who would have not consider initially being treated with the patch because their perception of the severity of their disease is different, because they are coping with a lot of different items in their real life. What is super interesting is that we recently, in market research, have retested at very large scale, our profile with the Phase II data. And the -- I mean, the bottom line of that is that with the current profile of Viaskin, we confirm that the product, actually, the potential to be a market leader, really, on the market because of the benefit/risk profile and the fact that it fits very much into the daily life of those patient. They can -- the back-to-normal idea is actually very important for those sort of patient.
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Tazeen Ahmad, BofA Merrill Lynch, Research Division - VP [38]
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Okay, perfect. With that, we're out of time. So thanks, everybody, for joining us. Thank you, Charles. Thank you, Susanna.
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Charles Ruban, DBV Technologies S.A. - COO [39]
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Thank you.
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