Sky’s the Limit with the Venerable Dr. Vicente Anido, Jr.

PODCAST EPISODE 269

Click here to watch the video version of this podcast.


Host Robert Rothman, MD, is joined by Vicente Anido, Jr., PhD, chairman and CEO of Aerie Pharmaceuticals. Dr. Anido shares his vision for Aerie, and how his lean, efficient team carefully strategizes every move they make to cultivate products that benefit patients. We learn background on both Dr. Anido and Aerie, and how two of Aerie’s products, Rhopressa and Rocklatan, were brought to market in under one year. How has Aerie made a name for itself globally within glaucoma, and next in dry eye and retina? Click “play” to learn!

Transcript:

Rob Rothman: Hello, everyone. Welcome to the OIS Podcast. My name is Rob Rothman. I have had the privilege of being a moderator for several OIS panels in the past, by way of introduction, I am a Board Certified Ophthalmologist, Fellowship trained in glaucoma, and in clinical practice, for a significant portion of my time. The remainder of my work days are spent as the Co-Founder and Managing Member of InFocus Capital Partners, which is an ophthalmic focused venture capital fund. Here in the US, we have a portfolio that consists of 12 ophthalmic opportunities, all early stage. And by way of disclosure, we do not trade in the public space, and therefore I have no interest financially with today’s guest. So that’s my disclosure. I am fortunate enough to have today for my first OIS Podcast, guests, Vince Avido who is the chairman and CEO of Aerie Pharmaceuticals, somebody who I’ve always wanted to sit down with one on one, we’ve had the opportunity to meet several times in the past. And we’ll discuss some of those reasons why I’ve always wanted to speak with Vince and Vince now you will be forever known as my first, so not to put too much pressure on you. But really appreciate you taking the time and coming on the podcast today.

Vince Anido: Well, thank you, Rob, and I promise not to screw it up, at least not on purpose.

Rob Rothman: Well, I do not make that promise. But too bad. Just the way it goes. I thought that in the in the spirit of homeschooling and the current academic environment, we would start today’s discussion off with a little quiz. So it’s a pop quiz for Vince didn’t know he was getting this, which I think is always exciting. And it should be pretty easy. So it’s one question. You know, I did a little homework before our discussion today. And I communicated with few of my ophthalmology friends that I put down on an email 10 ophthalmology companies, and I said send this back to me without looking it up and tell me who the chairman is, of our CEO is at each of these companies, all glaucoma focused into the glaucoma space? And who do you think was the one name that everybody knew on that list? Don’t think too hard, Vince? It was. It was you? It was you. So, you know, it’s a very interesting thing. And and I did that, because I started to think to myself, you know, I don’t necessarily know who the CEOs are of a lot of the companies whose products I deal with on a daily basis. But why is it that I know Vince, you know, what is it? What is it that makes it so that I have come to know your name. So clearly, when I haven’t had the ability to know that for many other companies, and I think it’ll be sort of a focus of the conversation today. And hopefully, we’ll get to it. But I’d like to start off if we can, today with discussing a little bit about you. So, um, I have no interest in becoming the CEO of a large pharma corporation. So that’s good, I guess. But I think there are a lot of people who would like to understand how that happens, you know, what is it? How is your educational background sort of helped shape you? How is that led you to, to the position that you’re in now? And what experiences have you had in your professional life that is sort of built up to you becoming, you know, the CEO of one of the most important companies in ophthalmology today. So I don’t know, maybe go back to the beginning how you grew up where you’re where your education led you all that stuff. Give us a little insight into the progress of Vincent Anido through the ranks?

Vince Anido: Sure. So I’ve been in the pharmaceutical industry pretty much all my adult life. And the reason that that was important to me is I came from a healthcare family. My dad, my dad was a doctor, his clinical pathologist, my mom was an operating room, head nurse. And I was born in Cuba. So shortly after Castro took over, we decided or they decided that it was time to move the family out of there. So I was about eight years old. And they took us out of there and moved us to Miami. And so I actually grew up in is what is now South Beach, went to Miami Beach elementary and then went on from there. And then eventually my dad got his medical license back. Now it’s probably one of the early learnings in that education for him was it. He said, no matter what, no matter who takes over a country, no matter what they try to do to you the one thing that you have that can always make you come back is you’re education for us was always very, very important. So he got his license back, and he became Chair of clinical pathology at West Virginia University. We moved there in the early 60s, and it was the first time I ever saw snow. And to this day, I still hate it. So that’s why I’ve always tried to live in southern climates. And so but I went to school there, because I decided a long time ago that I was going to pay my way through school, I didn’t want anybody worrying about me, I didn’t want anybody telling me what to do, what to study what kind of grades we get, which is probably a good thing because I wasn’t the world’s best college student. So I got my BS and my master’s degree from WVU. My BS was in Pharmacy, and my Master’s Degree was in Pharmaceutical Sciences. But again, following what I learned from my dad, I went on, and decided that after school, I had an interest, not so much in the science side, although I was okay at that. But it was mainly on the business side of pharmacy and everything related to pharmacy and healthcare. So I went to University of Missouri in Kansas City, and did two things, one, pursued a PhD there in Pharmaceutical Sciences so I completed that. But at the same time, I worked for my first pharmaceutical company, which at the time, was Marian Laboratories. Marion was in the gastroenterology, cardiology field. It was doing branded generics way back all the way from the beginnings in the 50s on through, and then we came out with two licensed products. One was called Carter’s and, and the other one Carafate, they transformed the company. So over a five year period, our stock doubled and split, five years in a row and they picked a number of us to develop in very, very quickly because the company was growing so fast. So I was one of just two or three folks that they selected for general management. And so I literally had a job, a different job every two years, for about a six year period. And then they actually sent me up to Canada to go run a 50% own business, which was a free standing pharmaceutical company, called Nordic Laboratories. So I lived in Montreal, for not quite four years, had learned language, because most of the folks here spoke French. And we ran our meetings in both English and French had an outside board. So I was, that was my first CEO gig. So I was in my mid 30s. And, and went through that, and then they brought me back to the US. And it was about the time that I met Gavin Herbert. And so Gavin is the one that convinced me to move to Allergan. And that was my first introduction into ophthalmology. And the thing that I learned from Gavin, and while it’s always an honor to be recognized in a surgery, like the one that you ran, I have to admit, I wasn’t 100% surprised, because the one thing Gavin taught me and everybody else who was there was the importance of the customer, no matter where we went, whether it was in ophthalmology meetings, or dermatology meetings, etc. Everybody knew Gavin. And so for me, the focus has always been about the customer. And so ever since I moved into ophthalmology, I got to do things we couldn’t do in cardiology, because there and gastroenterology just couldn’t get to meet all the doctors, it just wouldn’t have the relationship that we have in ophthalmology. So it’s a very unique grouping of people that both in terms of those that are direct patient contact and those of us who provide goods and services. And so not only in Allergan, but then our subsequent company ISTA. It’s what I learned how to fly, and I ended up flying all over the country, and I was able to visit doctors, where they practiced. So, you know, made it easy for me, I traveled the East Coast, and I spent a week or so flying up and down the East Coast, everywhere, just whenever the rep said, Hey, we need you to come in and talk to a bunch of physicians, we were there. And so I’ve been able to continue that not only post Aerie or post ISTA, but then brought that whole philosophy to Aerie as well. And so, whenever we go to meetings, like the medical meetings, I’ll go to OIS when we were holding those. And I would not meet individually with folks, I would not run any company meetings during those times. I was in the booth the whole time. So if anybody wanted to see me, I wouldn’t go back to a hotel suite. They had to come to the booth to meet with me. And so that allowed me to see a whole range of folks, not just KOLs, but anybody showed up with a suite, the reps would bring them over and we get a chance to visit. And so that’s been one of the greatest things for me as being a CEO of an ophthalmology company is the closeness that any of us can have with the customers. And it was all driven by what Gavin taught us.

Rob Rothman: Fascinating I can it I remember the first time I actually met you, which was in the booth, and it’s, it’s pretty fascinating. And for people who don’t know what, you know, these big ophthalmology focus meetings are like the American Academy of Ophthalmology meeting and OIS and ASCRS. And, and all these giant meetings, you wanted to say hi to Vince, you just go to the booth. And that was exactly where we met the first bunch of times. And, you know, it’s interesting that you’ve, at least in my opinion, surrounded yourself with people who buy into your philosophy wholeheartedly. I mean, the people that we’ve dealt with, in the real world, as an ophthalmologist, from Aerie, you know, some of the close contacts I’ve had with guys like Kevin Hawkman, and even my local rep, you know, Paul still, you know, and, you know, are all genuinely focused on making sure that, you know, we have what we need from Aerie, the company. And it’s, it’s, it’s certainly I think, a, a, a leadership attitude that has filtered down effectively through the ranks. So congratulations, I guess on that. So thank you. What, what kind of planes you fly, just out of curiosity?

Vince Anido: Well, I stopped flying a couple years ago. But the last plane that I flew for a little over 10 years was a Citation V. So it flew, you know, we can carry eight people, we flew up to 43,000 feet, about 525 miles an hour, somewhere in that ballpark. And we could make it halfway across the country before refueling and then go land at Teterboro or any other airport on the east coast. We wanted to go to Boston and things like that. And I could always beat the airlines. Because, you know, again, you know, it takes so long to go sit at the airport and kind of wait for the plane to take off and this and that, where I would just drive up. I had a co-pilot and he and I would trade information about the weather and route and all that other kind of stuff. And then I do a walk around and jump on the airplane and we’d be gone.

Rob Rothman: It’s fascinating. It’s a nice way to do it, if you can do it. Yeah. Pop quiz question number two for Vincent Anido, who was the only CEO who ever came to Long Island and took the administrative group from our practice out to dinner?

Vince Anido: We guess? That was, I guess…well…

Rob Rothman: I mean, again, you know, I’ve been in practice, you know, again, as an ophthalmologist, I’ve been in practice since 1998, I can tell you that. That was the singular time that we were entertained at dinner by the CEO of a pharmaceutical company. And again, and you know, where we’re, you know, I’m part of a glaucoma consultants of Long Island, which is a glaucoma subspecialty group, but we are now I’m a member of a private equity-backed entity here in New York, OCLI. And, you know, this was just a dinner just to say hi, there was no agenda we didn’t talk about any products, there was no sales pitch. This was you saying, hey, like to come out to dinner and hear how it’s going for you guys in New York. It’s just the it’s a very unique. And again, I know, we’re having this conversation. And I’m sure you’ve heard this before. But it’s a very unique style that I think that sort of endears people, to a company or a brand. And I think that attitude is further supported by quality of the products that you provide. If you had good products and horrible management, I think you would find that the attitude towards you know, the products from that company would diminish. You know, I think people really appreciate management style, especially in ophthalmology, which is a small, tight knit community compared to some of the other disciplines in medicine. And everybody sort of knows everybody. And it changes I think a lot of the ways that you really need to do business and I think one of the things that’s come up repeatedly in my conversations now as a, you know, part-time venture capitalist is how we perceive Aerie, as, you know, one of the future, important people in our specialty and a company that we hope continues to grow and support us because, you know, we need some of that tighter knit, more personal approach to how we care for patients because of the uniqueness of the way ophthalmology is practiced. So I think with that, as a segue, I’d love to hear a little bit about Aerie from your perspective, I don’t think a lot of people who listen to the OIS podcast have any idea where Aerie came from. And it’s a fascinating story to me as a glaucoma specialist, especially having known David Epstein in a very cursory way for many years, through his research, and obviously, as a glaucoma specialist knew of him very well. But maybe you can walk us through a little bit about the origins of Aerie. I think it’s fascinating.

Vince Anido: Well, it was really interesting. So David always had this whole philosophy about in order to treat a disease, you have to go to treat the underlying cause of that disease. And then glaucoma is, you know, is a disease trabecular meshwork. And so he spent an awful lot of time in his labs and talking to people and trying to drag venture guys in to do nothing but explore molecules that could actually improve the health of the trabecular meshwork. And so he teamed up by luck with a gentleman by the name of Casey Kopczynski, who’s our current Chief Scientific Officer, head of our Science and Technology Group. And Casey was biologist by training, had been at a startup out on the west coast and move back. And he has a PhD in biology of all things. And so they hooked up, and Casey’s thing was using live animal models for testing, as opposed to what a lot of companies do- in vitro testing. And so the two of them got together, and there was a gift from Procter and Gamble, when they disbanded their pharmaceutical R&D unit, and that included a Row Kinase library. So they started testing all these molecules, there was none in that library that made sense. And it was mixed up with some other molecules and things like that. But with a came up with this, so chemists, so they added him to the picture. And they started testing things, and Casey came up with all these animal models, they can mimic, what would happen if you put a drug on a living organism, you know, some one of the animals that they were using for testing. And they came up with one that was very, very predictive for what would happen in humans, and medicinal chemists actually went off and was, you know, adding his little ornaments to these pharmacophores. And, you know, trying to come up with, you know, various things that it could do. And they came out with a very potent molecule that got tested in the animals first went into humans, did a great job. And that was the first product the company had. And it was great until we actually put it into the first of the phase two trials. And we found that the drugs were great for a very specific period of time. But that was about the time that I came in. So all this that I was describing took effect from about 2005, to about 2013 or so. And so when I came into the company, I said to Casey, look, you know, it’s great that we have this molecule, but we better have a backup. And so he came out with a backup, and it was, again, dangling the little ornaments off of the exact same molecule that works so well. And what we found was that second one, had the same efficacy as the first one, but actually had no tactical access, we didn’t lose efficacy over time. And that’s what came out as repressor. And so we had them both in the clinic, and we were going to choose between them. And it just turned out that the repressor molecule actually made it all the way through. And I think you’ve probably seen some of our data that goes all the way out to a year with pretty stable iOPS, which is incredible in the field that we’re patient we’re trying to treat. And so in parallel, we decided that we were going to take the company public, and unfortunately, the gentlemen that we had running the company at the time, when I came in as executive chairman, just wasn’t going to cut it with public investors, we put him out there and talk to a bunch of folks. And because I’ve had two other public companies prior to Aerie, I knew a lot of the investors already. So I sent him to a bunch that I knew and got feedback in terms of the story in the management team, etc. And we decided to make a change. And one of the options that eventually the board ended up taking was me coming back into an operating role, even though I’ve been retired for a while. And so we did that brought in the management team. And from the time we did it, which was in July of 2013. By October of that year, we got the company public and Rocklatane which is the biggest drug that we have currently out in the market. Actually, when we went public, all we had was animal data. And so we moved very quickly from having animal data in 2013 to actually having phase twos in the 2014-2015 era, and then everybody kept saying, well, we haven’t had a new drug approved for glaucoma forever a new chemical entity, much less no one’s ever approved. And certainly Wiley hates combination products. And we kept saying, yeah, but if we, if what we learned a long time ago is if you do what Wiley suggests that you do, and the drug works, you get an approval. And so we’ve been listening to him pretty closely. And we have a great head of regulatory QA that’s got something like 40 drugs approved within ophthalmology in the US and a bunch abroad as well. And so he taught us how to listen to Wiley we did and long story short, we got both drugs approved within a year of each other. And so we’ve been very, very proud of that accomplishment. And, and as you know, the biggest challenge now is how do you repeat it. And so we do spend quite a bit of time on the pipeline. And we’ve got a growing pipeline that not only includes some future glaucoma meds, but also moves us into dry eye and retina, we bought a company called Envisia. The gate is the ability to create these small inserts, but we can take small molecules, and then mix them with polymers. And we have to deal with a huge polymer company in Europe, where we can mix and match these things to create the best environment for that drug, and then make these tiny inserts and inject them in the back of the eye. It’s very predictive. And so we’re able to move that forward. So it’s a it’s been long, it was a long road for those who started in 2005. But you know, we still have in the company, we have about 400 people in the company, but about 10 of them were originals. There’s the witness.

Rob Rothman: Yeah, it’s great. I mean, you know, and again, for people who aren’t ophthalmologists who might be listening to this or, specifically not even glaucoma specialist, but it’s fascinating was always fascinating to me, as a clinician that even up until you know, up until the time that real presser came out, we never had a job that acted directly on the site of damage and glaucoma. We had all these workarounds, you know, reducing aqueous production and increasing uveoscleral outflow and all these other ways to lower pressure but we know that glaucoma is a disease of speculum meshwork. And we never up until Rhopressa, you know, became available, how to drug the act that at the site of actual damage, and I think when I go back to all those lectures that I heard David Epstein, you know, give before his passing, and, you know, where he was commenting on how ridiculous it was that we didn’t have this and that his singular mission was to go out and figure out how to find the drug that did that, and how you guys eventually came in and helped commercialize that to help with the realization of his dream is just a fascinating story of where a pharmaceutical company comes from. And really, when the foundation is looking at an unmet need, or looking at a specific target that you know, is going to work going out seeking out the the chemical entity that’s going to solve that problem, getting it through clinical testing and commercializing, especially, to drugs that do it within 12 months of each other, you know, Rhopressa and Rocklatane within a year. Right. I mean, it’s a fascinating, it’s a fascinating, you know, progress. And I think that’s one of the reasons why, you know, a lot of us look to areas, a company that’s going to make these types of introductions for us to new products and new ways of treating disease, because you’ve already done it once in glaucoma. And we certainly know that you’re looking to do it and dry eye and retina in other ways. So I think that’s somewhat of a differentiator. And I think, and again, I’m speaking for myself, but again, it’s a consolidation of general opinion from colleagues that you guys function in a very lean, efficient and nimble way. And hopefully, we’ll continue to see, you know, these products getting through clinical trials, I know that you have a Phase 2 study going on going on for your dry eye product right now. Is that correct?

Vince Anido: Yes. Yes, the product is, we designated as 512. We bought a company, a Spanish company that had developed this product had a Phase 2a study and we love the technology, we love the target. And obviously everybody loves the dry eye space because the 30 million patients but only two or 3 million of them get treated. So it’s a big deal. But our drug is a agonist to the cold sensing receptor in the eyes. So given that where you live today, if you were to walk outside and you get hit with that blast of cold air, the very first thing that happens is your eyes start tearing up.

Rob Rothman: Thanks for rubbing that in, by the way.

Vince Anido: Yeah, you’re welcome, to be and so this agonist family, and this particular receptor is one that hasn’t been chased before, at least not in ophthalmology. And so we find that the same mechanism will give us both sign and symptom improvement. So the sign is clearly going to be just to be tear production, we know that we can do that we’ve seen it in the Phase 2 trials and the Phase 2a trials, we’re moving into this Phase 2b trial that’s actually powered as a Phase 3. So we have enough patients in there. And a broad enough protocol that we think that we can get all the data we need out of this trial to go into if it works, just have one more trial do the same concept, it the same receptor, actually, when we put the drug onto the eye, it cools it down, that’s one of the things that the patients continually feedback is my It feels like I just put a little ice on it, it just cooled, it’s a cooling effect. And as you know, for the patient’s dry eye isn’t about signs. It’s about symptoms. And so if we can improve the symptoms, we’ll get this stick-to-it-iveness, I’ll stay with that drug, as the signs continue to sort of kick in and hopefully improve their condition. And so, you know, we will find out, we were very pleased with the way the Phase 2a was conducted and the results that we got. And so we decided not only to run this trial with a sufficient number of patients to make it a three if everything worked out. But we backed up the truck from we ended up putting in all these secondary endpoints, we’re using a dry eye chamber, we’re using the environment. So what we wanted to do was build a database around the drug with the first trial. And the reason for that was twofold. Number one, if it worked, we’re gonna we had the choice, right, either I can do just one more Phase 3 trial, duplicate this one. But as you know, folks have tried to do that. And sometimes it doesn’t work. Or you can simply do one of each, you could do 1 for signs and 1 for symptoms. of so you run two more trials instead of just one. So it gives us that flexibility. The things that we learn out of the repression Rocklatane, because again, new class into an established area, lots of generics in that category, as we’ll have it dry eye with Restasis going generic etc, is that in order to get your product on the formularies, in managed care, you better have not only an approval, but you have you better have a pretty darn good story, right. And so that’s what we’re trying to build by expanding the protocol to include all the secondary endpoints. And there’s all sorts of little twists and turns that we put into the protocol that we think will make for a great story, not only for the patients, but also for eventually getting it onto managed care formularies.

Rob Rothman: Yeah, absolutely. And when we expect to hear some of this the Phase 2b potentially slash three, data readout, do we have any idea when you’re planning on completing?

Vince Anido: Oh, again, because there’s plenty of patients out there. So enrollment has not been a problem. We think it’ll be Q3 of this year.

Rob Rothman: Right. Well, obviously, looking forward to that. It’s interesting that, you know, the genesis of that I wasn’t aware of how that, you know, compound came to be, you guys grew Rhopressa. I think internally you’ve acquired INVISIO. And this asset for dry eye, you have a library of several thousand, multi kinase inhibitors at your disposal, you foresee the future very being this continuous mix of in-house development, acquisition, external product sourcing? How do you how do you foresee the interaction of all these things as you continue to grow and become a larger piece of the ophthalmology pie?

Vince Anido: I think it has to be played out that way. I think if you take a look at the company that had been successful, and you know, think about Alcon, they hardly ever developed any compounds on their own. They were always I mean, they were big enough, they could acquire whoever they want to. And so that was the research side. And you know, Jerry Kay goes on my board. So he and I have created a lot of barbs back and forth sometimes an Allergan guy about that. And so, but ophthalmology started simply by borrowing drugs from other therapeutic areas and applying them into ophthalmology, thinking of nonsteroidals and the anti-infective etc, etc, etc. And even many of the retina products come out of the cancer field, right. And so here, we’re trying to do a little bit of everything. So we’re trying to, you know, we’ve invented our own molecules, I still have medicinal chemists running around, I still have guys that have replaced now, Casey, in doing the animal models, because what we’re trying to do is to figure out how quickly can we get a drug in the hands of the practicing doc’s do a small clinical trial. That’s really the only time you really know whether you’ve got something or not right. And so our whole philosophy is to do that. And so we do see us continuing to try to invent entities. We will opportunistically look at acquisition of companies or technologies to bring in and INVISIO is a good example the company that we bought in Spain was another one. And then we now have because of the INVISIO acquisition platform with our print technology. So the print technology is basically the ability to make these tiny inserts and then we can inject either front or back at the eye. And we’re focused on the back of the eye on the retina side, we can take molecules, and our proof of concept really was 1105, which is dexamethasone inserted into the back of the eye to treat RVO and diabetic macular edema. And so we were able to show that with our technology, and our ability to mix and match polymers, we can take dexamethasone and deliver it for six months. The current products either go out three years in the case of Iluvien, or they’re much shorter than that in the two to three month range in the case of Ozurdex. But we called out and talking to the retina physicians, which is one of the other reasons I like to travel. Is that it, they said no, no, no, the way that my patients work and things like that, if six months is the best target. So that’s what we did. And what was interesting is in looking back on the development in our built, it was our ability to predict based on animal models of retina, how well the drug would work and for how long in humans. And that translation from animal models to human models and be able to predict that with a retinal insert on your first shot out, it was a pretty big deal. So now we can take other small molecules, mix them and match them with whatever polymers we want. Put them into our insert and deliver them to the back of the eyes. So it expands. So it makes it a platform technology at the same time. And this is the fun part for us because it bridges, glaucoma and retina. Now we’re taking a look at 503, which is the most active metabolite of a Rhopressa. And we can put that into an insert go into the eye, we have plenty of animal models that show that we can in a nerve crush model, we can actually get the axons firing again. But we don’t know, we know we can deliver that small molecule back to the eye for six months or a year. But we don’t know is what’s the right concentration of 503 to get that effect over sustained period of time. So again, a lot of flexibility in the print technology. So we’re in the clinic now with where we can inject more than one insert just to see what the concentration really needs to be. And then once we figure it out, then we can go back into the formulation side and come out with making sure that we just have one insert or just one injection, to deliver and that’ll last for six or 12 months. So huge amount of flexibility. So we could do things only on our own. But we continually look at folks that are companies that have things that on our own, we couldn’t do and and we know how to do clinical studies, we know how to do the regulatory stuff, we know how to get those drugs approved x US. So it gives us a great execution prep platform from which to grow.

Rob Rothman: I think one of the biggest unmet needs in ophthalmology is no drug delivery, taking patients out of the equation to some degree. And having acquired a drug delivery technology, I think is a fascinatingly intelligent decision to try and figure out how we can better deliver drugs, it’s seems so easy to just put a drop on the eye and it’s so unbelievably challenging to get patients to actually behave and do these things regularly. So that’s a great, you know, great strategy. In my opinion, the more fascinating aspect is how real kinase inhibitors I think are going to continue to play an important role in the health of the eye mean, we’ve already got evidence from Rhopressa that there is a beneficial effect on lowering intraocular pressure. We’ve seen some of the data outside of the United States that shows the impact of rural kinase inhibition on corneal endothelial modulation in patients who are using these things, you are looking at it, obviously it looks like or it sounds like neuromodulation, potentially neuroprotective aspects of it. So there’s a lot of different things and rho kinase, I think is rho kinase inhibitors are probably at the forefront of their potential in terms of their ability to help ophthalmology patients. You obviously have a plan to provide these drugs outside of US and certainly with dexamethasone, I think that many people may not know about your relationship with Santen and maybe you could just spend a minute or two telling us about your plans for how Aerie is going to give access to their products outside the United States.

Vince Anido: Sure. So our globalization strategy originated with the fact that we own these molecules. So unlike my last company where we were in licensing products, and all we could do is US here, we own the app date, all of the rights. And so we could always do it ourselves or partner it off. But we decided to do was that we would take the very first step and take these products, either through all the way through approval, or at least through a proof of concept, but a full-blown proof of concept, phase two trial. And so what was interesting is, originally we thought that in Japan, we would do get all the way to approval with Rhopressa. And then somewhere along the line, find a commercial partner, because we realized that as a small company, much as a non-Japanese company trying to launch products in Europe, we aren’t sorry, in Japan, that we would have some issues in terms of being accepted by the physicians, etc, etc. And so we did the first Phase 2 trial in Japan. And it was outrageously successful. You know, this is a drug that actually is able to lower pressure, even when the patient’s starting pressures are pretty low. And so we still saw the five, six millimeters of mercury drop, even though the entry pressures within the 12-13 range. And so that was a fascination to the doctors. And so applying the same concept of getting close to the doctors that we did in the US, we did that in Japan, so we got to know all the major players. And there’s a gentleman, Dr. Aihara, who is the head of Glaucoma, as you know, Tokyo University, which is sort of the Godfather, they’re gotten to know his successor, and then a number of other players. And so they fronted us not only with getting the clinical study done, so they’re FDA called the PMBA. He was there with us. And I went along with Casey and our clinical and regulatory teams to present our case, and we were able to get agreement in terms of what to do. And so once we got the Phase 2 trial results, and they were positive, all sudden, we started getting calls from major Japanese companies. And so after a long negotiations, we selected Santen, because they are the largest there, they also have a huge franchise in glaucoma on a worldwide basis. But we were interested in Japan. And so we decided, in order to keep pressure on the negotiations, we continued all the negotiations with a PMDA on the Phase 3 program, as if we were going to go do it ourselves. And we actually started the first of the Phase 3 trials. And so because we didn’t want them or negotiations for a partnership to slow us up, and so that played out pretty well, it did put an awful lot of pressure on the system and put a lot of pressure on the companies to kind of come together with offers that were interesting to us. And we were able to get to the point of signing a deal with Santen last fall, which brought in about 15 million upfront, you know, typical milestones and royalty payments and things like that. And the other thing we were interested in was manufacturing the product. So it will be made for Japan, out of our plant in Ireland. And so as soon as we finish that first Phase 3 trial, we have a small team of about five or six people in Japan. As soon as they finish with that first trial, we’re going to move in over to looking at the dry eye product as well as the retina products in Japan. So we’ll continue with presence there. Because all we’ve done is out licensed Rhopressa and Rocklatane in Japan. Europe was the same story, we ended up doing a, not for approval, but a study comparing ourselves to a product called Danforth, which is a combination product. So we compared Rocklatane to that combination product. reason we did that. It’s the highest price combination product in Europe. So we do noninferiority, we get that price with the pricing authority. So that that was the main target there. And we were successful in doing that. And just like in Japan, as soon as we unveil the clinical result of call it mercury 3. All of a sudden, people start calling us both global companies as well as European centric companies started calling us about taking our product into the European market. Now originally, we thought we would do that on our own. And the more we took a look at it, the harder it became because we could do country by country. We would start in Germany because that’s the free-est of all the pricing authorities that you have there and it goes all the way down to the really tough ones. And so and slowly build our franchise in Europe on the glaucoma side with our own sales and marketing effort. But these companies are started calling us we’re putting enough interesting offers on the table and they could launch good both Rhopressa which is called Rhokiinsa in Europe, and Rocklatane, which is called Roclanda in Europe, both of them are now approved. So we said, Look, you know, the offers are interesting. And they can launch in all markets at the same time. And so we got to thinking about that and started doing the math. And it’s relatively straightforward. The prices over there are much lower than they are here in the US about lead product, again, goes for about $27, a bottle or something like that. But a leading product in glaucoma sells 5 million units, which is a couple million more than we would sell here. Because they just have more volume of product being used over there. And so big product over there between 100 and 50 million US in net sales. We started looking at then the retina products, especially the steroid and said, Wait a minute, you know, that product could be because Europe uses more steroids for retinal diseases than we do here in the US. Over there, that product itself 300-350 million. So I’m not a math major, but I’m pretty sure 300 is better than 150. So we said how about we just partner off glaucoma. And then we’ll take not only the dry side, but we’ll also take this the retinal side and keep it for ourselves. And so that’s what we’re doing. The other benefit is, if I add 5 million units to my manufacturing facility in Athlone, we’re running at probably full capacity, and I may have to add a second shift. So all of a sudden, that facility is fully functional Cost of Goods comes down, we own the rights we own, we control the supply, and that’s the best of all worlds for a pharmaceutical company. And so we made all the sense in the world to partner Europe, as well as Japan. For us.

Rob Rothman: That’s great. I mean, again, you know, it you know, I, I’ve been around, probably longer than I’d like to admit and, you know, having watched the growth of, of Aerie, from infancy through now, it’s just fascinating to see the development and how you, you know, started, you know, at least in the world as a glaucoma company focused on the US product. And now you’re sort of a global entity with glaucoma, dry eye, and retina. And, you know, again, I guess the only thing I could say is congratulations on that growth and development. And, and I think that, you know, we will continue to see important products, like Rhopressa and Rocklatane, that have helped change the way we manage glaucoma patients come out of this company, because we think that the attitude that you have towards finding products that are needed and making sure they get to the patients, and continuing to invest in the development of both processes and products that will benefit, you know, patients that we care for. It’s just been exemplary. So, you know, I wish we could continue to talk for about, you know, you know, the rest of the things and questions that I have, but I think we probably should wrap it up here a little bit. I will say that I did learn some very interesting things about Vincent Ito today. So you know, I did not know you were born in Cuba. Technically, it is Dr. Nieto. It is technically it’s Dr. Nieto. And I think that I will have to call you that going forward. Not that you expect people to do it. I don’t know how you treat that doctor thing. But I only make my patients and my mother call me doctor, everybody else

Vince Anido: That most people don’t think I look smart enough to have a PhD. So for me, it’s okay. They don’t call it you know that.

Rob Rothman: I didn’t know that whatever.

Vince Anido: You know, for formal document is about the only place you’d ever see my PhD attached to my name.

Rob Rothman: Okay, I did not know that. So now it’s Dr. Anido. And I did not know that you flew jets. And I also believe but did not know that you hate snow. And that would explain why you’ve continuously mocked me while you’re in Florida. And I’m sitting here in New York. So I appreciate that.

Vince Anido: For round two, just to show you our 80-degree weather today.

Rob Rothman: That would make us not friends anymore. So anyway, listen, Vince, I really appreciate you taking the time today to talk with me. I think. You know, I’ve enjoyed hearing about your growth and development, and certainly look forward to continuing to speak with you about Aerie and its progress. And I know we’re going to continue to see great things I hope the listening audience understands the significance of your company, to ophthalmologists and to the care of patients and, and once again, you know, congratulations on the success and looking forward to seeing you know how the future treats area as well. So thanks again for your time today.

Vince Anido: Oh, you’re welcome. And thank you for the invitation. And we’ve always been big supporters of of your group and expect to continue to do so in the future. So again, thanks for everybody and, and it’s been a fun ride.

Rob Rothman: Yeah. Thanks, everybody at OIS and looking forward to a future podcasts going forward.

Do You Have

A STORY TO TELL?

If you’d like to be considered as a guest on a future episode of the OIS podcast, please complete the application today.

Meet Our Hosts

Ehsan Sadri
ehsan sadri
Firas Rahhal
FirasRahhal
Paul Karpecki
Paul Karpecki
Subscribe

ON iTUNES

Don't miss an episode. Join the conversation by visiting our podcast channel on iTunes today and subscribe. It's fast and free!

STAY UP TO DATE WITH OIS

Get the Latest News, Podcasts and Videos.