Industry Spotlight: Santen

May 17, 2022 00:27:31
Industry Spotlight: Santen
Dry Eye Coach
Industry Spotlight: Santen

May 17 2022 | 00:27:31

/

Show Notes

Interview with Peter Sallstig, MD, MBA

Santen’s legacy, global products, NA product portfolio, clinical trials and more.Peter also dives into the disease state of vernal keratoconjunctivitis (VKC) and the recent US launch of Verkazia®, the first and only topical immunomodulator approved for the treatment of VKC in children and adults

View Full Transcript

Episode Transcript

Speaker 0 00:00:00 Welcome to the dry eye coach podcast series. Click on dry eye. Your insider passed to the most exclusive dry topic. The series will raise awareness about the current and future state of ocular surface disease. The podcast will focus on a variety of topic. Speaker 1 00:00:15 Well, welcome to our industry spotlight. My name is Wal Whitley and we also have Tracy doll here with us as well. And our guest, our guest today is Peter ting. Who's a global head product development and chief medical officer at Santon pharmaceuticals. Welcome Peter. Speaker 2 00:00:33 Thank you so much, Walter. Appreciate having me. Speaker 1 00:00:35 Yeah, we're excited to have you here and thank you for being a sponsor for click on dry eye, but we wanna focus here on Satton. Can you tell us how long you've been with Satan and what is your current role? Speaker 2 00:00:47 Absolutely. So, um, I've been with the company now for close to, uh, three and a half years, uh, before that spent most of my pharmaceutical career, um, with, uh, with Novartis, um, ACON, Speaker 0 00:01:01 What is your day to day work entail? Speaker 2 00:01:07 So, um, you know, um, just, I, I was just recently, um, kind of given this, um, additional, um, task of being the chief medical officer here at, um, at sent and so, you know, from a kind of, um, day to day. Um, so it's a global role. So from that perspective, it's really, you know, trying to understand the, um, the changes going on, um, globally, um, you know, depends upon its social, economical, um, technological, but it's really about, you know, how, how better we can actually help our patients. So, um, the, the kind of drive to try to bring forward, uh, the, the insights with regards to the patients that's been really, you know, one of the core principles I would say of Santon for the last hundred 30 years since they've been around. Speaker 1 00:01:54 Yeah. And we, and we're, we've been really excited working with Santon, um, you know, with, within the eyecare space. So what are the biggest current and future growth areas and opportunities in eyecare? Speaker 2 00:02:08 Uh, that's a good question. Um, so I think, you know, there is obviously, as we all know that there is a huge, um, medical need and I think, you know, it's, um, always gonna be there. Um, but I think it also depends upon the kind of the, the maturity of the country or region, you know, if it's a developed or developing country. Um, but, but overall I would say, you know, the, the, uh, the need for innovation remains. And so I think, you know, Santon, we we're quite uniquely, uh, situated, uh, since we cover basically all areas of, um, ophthalmology, you know, it's from glaucoma front of the eye to, to back of the eye. Um, most recently we've also kind of versed into gene and cell therapy. So, um, you know, overall, I, I think people are definitely, you know, interested in innovation that has a positive, um, impact creating an easier life. Speaker 2 00:03:02 Um, for instance, you know, needing to have, uh, less drops, um, of any kind of, um, medication or much longer, you know, duration. Um, so, so I think, you know, that, that that's really what, um, patients are, um, looking for. And, you know, another area where we kind of have dwelled into most recently of course, is, um, myopia, um, which is a huge, um, issue particularly, um, here in the, um, Asia region, uh, in China where it's just most recently, you know, has been, uh, recognized as a national health issue by the, um, Chinese CDE. Um, and as I mentioned, you know, last few years there has been also Anick in gene therapy options. Although I, I, I would dare to say they're actually still, uh, relatively limited. So I think, you know, overarchingly, there is a huge area still where, um, we can actually still bring forward, um, new innovation, but, uh, as I mentioned, you know, myopia is definitely one of our key areas. Um, as, uh, from, from Santa's perspective Speaker 0 00:04:08 Now, Santon isn't new to being, um, part of a global leader in healthcare. Can you tell us a little bit more about what their legacy is and, um, where Santon came from? Speaker 2 00:04:20 Absolutely. So, um, so Santon was established more than 130 years ago. Um, and it has grown quite considerably the, uh, the last, you know, five to 10 years. Um, but ophthalmology has always been, uh, an area where we've been focused upon. And, uh, so, so I would dare to say, you know, we, we understand this quite well after 130 years today, we, we have a presence, uh, in, in most areas of the world. So approximately 70 countries and increasing, uh, originally, uh, from Japan, this is also where we have, um, our headquarters, but literally, you know, we are, we're covering most geographies, um, Japan, China, Asia, Europe, uh, most recently also now, um, here in the states, um, quarter main wise, um, you know, it's, it's glaucoma, dry eye allergy. And, um, as I mentioned before, you know, most recent, we also added some additional new domains, uh, such as for instance, um, myopia or posis or gene and cell therapy. So, um, that's a bit about the background mm-hmm Speaker 1 00:05:28 <affirmative> so globally, how many patients have sented, uh, global products treated? Speaker 2 00:05:35 Yeah, that's a big company question and, uh, yeah, I mean, from a global perspective, I think that that would be, um, you know, quite tricky to answer, you know, back then 130 years ago, I don't think the, uh, they were really, you know, counting and checking, but, um, but I think, you know, if we just look at our, um, product portfolio, it it's really vast quite frankly, and it is often embarrassed between countries to countries. So if you take, for instance, Europe, you have different, um, you know, drugs, um, that we have in Germany compared to, uh, France, you know, often it also has to do something with reimbursement and so forth. So, um, I think, you know, overarchingly, it would be really, <laugh> hard for me to, to, to say. Um, but I think, you know, if we were just looking also about the, uh, the portfolio in general and you know, what we have right now is the, um, upcoming launch of, uh, Verium, which is a, uh, product, um, indicated for a VKC, um, which, uh, is obviously, you know, uh, as you know, in, uh, orphan disease resembling, um, allergic, conducting devices really impacting, you know, the, the lives of the, um, the children, particularly in important years, such as, you know, when, when they starting school. Speaker 2 00:06:52 So, um, you know, if you, you don't have a treatment it's really impacting their ability to learn, you know, creating stigmas and, and so forth. So, so we are really happy, uh, that we actually have this, um, opportunity and this, this is, you know, this, this is, um, one of our first treatment options that we are bringing here, um, to the us. So that's why we are really excited about that. Speaker 1 00:07:15 Mm-hmm <affirmative> so Speaker 0 00:07:16 I'm excited for treatment for VKC aren't you all? Speaker 1 00:07:19 Oh, definitely. Definitely. Uh, you know, so as we're talking about that, can you just, uh, explain for our listeners, you know, what is VKC its pre prevalence within the United States, including why it affects children largely over adults? Speaker 2 00:07:34 Yeah, so, so D KC, as I mentioned, I mean, this is, you know, it resembles really, so, so it's a Vernal or car conjunctivitis, and it really resembles that of a, um, allergic conjunctivitis. You have inflammation courageous also often in these patients. And often you see this, you know, starting in, um, ages of, you know, age of four, five years of age. And it actually does go up, uh, all the way until, um, adolescents and, um, sometimes even up into adulthood. So it's not necessarily just, uh, you know, focused upon, um, younger children, but it, it actually spans, um, uh, quite quite long so to speak. Um, if we're just looking, you know, from a geographical perspective, I mean, um, initially, you know, this is a disease that, uh, was particularly predominant in the more kind of, uh, Dr. Areas, uh, if I can call it that way, but, uh, obviously with a lot of movement with a lot of changes also in the environment, I think we, we were seeing an uptick here. Speaker 2 00:08:38 Um, it, it is an orphan disease. So, so the number of patients is of course, uh, still limited, but that's why it's so important that we actually have a treatment option cuz otherwise, I mean, this is a disease that would've been easily forgotten and I think, you know, often it is misdiagnosed the for instance, um, allergic conjunct devices. So I think, you know, it is absolutely critical that um, physicians and optometrists perhaps, you know, see also these patients can actually get a very good understanding of, um, you know, what it is, how to diagnose it. And then of course, you know, being able to treat them. Speaker 0 00:09:14 Yeah. Can you explain to our listeners, um, how, you know, the severity of this condition really affects the lives of the patients because while it looks kind of like an allergic reaction, it's far more severe than that, right? Speaker 2 00:09:27 Yeah, no, absolutely. Absolutely. And I was trying to kind of allude to this, you know, you really have this, um, this issue because it is very, you know, it's very severe itching. It is extremely, you know, painful condition. Um, patients often has also, uh, bad Pitis so they, they really have difficulties even attending school and all the complications that follows with that. Um, so I think, you know, having treatment options like ver CIA, where you can actually get the lives back on track for these patients so they can go to school so they can go out and play with their friends, I think is absolutely critical. So, um, yeah, it's um, it's, uh, it's a quite severe disease. Speaker 1 00:10:12 So Peter, can you talk about VICA? So how does it work? Speaker 2 00:10:19 Yeah, so, uh, I mean basically what we're talking here about is a, um, Konic nul utilizing a, um, technology it's called Nova sob. Um, and, and, and basically what, what we're trying to do here is to have that emotion binded to the, um, ocular surface and utilizing here the difference, you know, the electrical charges, so to speak between positive and negative. So basically what this technology that we're utilizing does is it actually maintains the, um, the emotional for a longer period of time, um, on the, um, ocular surface and thus allowing it really to, um, penetrate and do what it's supposed to be doing. So that's in a nutshell high level Speaker 0 00:11:03 Mm-hmm <affirmative> drug delivery is so important. I love now how, um, this, these innovations are coming up with ways to get the drug to the surface, um, better and stay longer. Speaker 1 00:11:15 So what are some of the clinical studies, uh, in regards to BRCA approval in the United States? Speaker 2 00:11:22 Yeah, so, so I think, you know, the, um, the main study that we conducted, uh, was the, um, vector trial, um, which is our phase three program, uh, where we, uh, really, you know, looked at, um, different doses, um, of, um, of SIA. Um, and, and basically that this was a trial, you know, it's a four months and then a follow up 12 months and you were actually able to see that statistical difference and that impact that it has on the patient. So we really are, you know, excited about having, uh, that data where we can really show the, the impact that it has and how much better actually the patients can get, uh, with the treatment. Speaker 1 00:12:04 Mm-hmm <affirmative> can you remind me what is the dosing and duration of therapy for Veia? Speaker 2 00:12:11 Yeah, so, so in this case, so, so we are utilizing it it's, um, four times a day, uh, dosing and, um, agree, you know, it might be a bit, um, it, it might sound, uh, tedious, but at the same time, you know, if you're considering the impact that it has on the patient's life, um, you know, I think it's, it's definitely worth while, uh, with that. And, um, it it's cycle SPO, so it's a 0.1, um, percentage concentration. Speaker 1 00:12:39 OK. Speaker 0 00:12:41 So will many of our patients who are suffering from ocular surface issues are already using things four times a day, so that doesn't actually seem out of the wheelhouse for treating things on the front surface of BI. Um, so why is the VII FDA approved of the United States, so significant to patients and your company, as opposed to other treatments and how are, you know, compared to other things that they had used before? Speaker 2 00:13:09 So, um, so yeah, so, so I think, you know, the, the reason why it's so significant, um, is of course the fact that there hasn't really been a treatment option indicated for BKC previously. So, uh, you know, in the past, the physicians tries to treat the patients with whatever Materium they had, um, to, you know, to steroids or to, um, or so be. So, so I think, you know, having something which, um, is readily available, which is so to speak at the shelf and, um, approved is absolutely critical. And, um, you know, you, you actually have studies therefore also to, to support it to back it up. So hopefully that also gives, uh, physicians, um, and particularly the patients, the parents, the, um, the confidence that this is really, you know, something that, um, is really gonna be how to say, um, helpful and useful for them. So, um, that's why I, I personally think that this is really great because there was nothing out there previously, everything else was, you know, off-label quite frankly. Speaker 1 00:14:19 Yeah. And, you know, when we're thinking about the, the treatments that we had previously, it was steroids and we could use some allergy drops as well, but we're using these in young kids and thinking about the chronic use of this medication, can you speak to the safety profile, uh, for VECA? Speaker 2 00:14:37 Yeah, no, absolutely. So I think, you know, if we're just looking at, uh, you know, from a clinical trial perspective, um, haven't really seen anything besides, you know, what is well known from, you know, usage of, um, cyclosporin so to speak. Um, so there is nothing else that we've seen that actually pops out from it. Um, and like I said, I mean, this, this is, this drug now is actually not just approved here in the us, but we also have it, uh, around the world. So we're getting more and more safety data. And, um, so far, like I said, um, everything, according to what we know from, um, previous cyclosporine treatments. Speaker 0 00:15:17 So my main concern when I have to treat, you know, younger kids as steroids is an increase in, um, interocular pressure. And your data does not show that there's an increase in interocular pressure, correct. Speaker 2 00:15:29 That's correct. Mm-hmm, Speaker 0 00:15:30 <affirmative> Speaker 1 00:15:31 Peter, we're gonna, we're gonna switch gears going back to, to St. North America and, you know, can you talk about the current product portfolio we're, we're aware of the, uh, acquisition for IVANS and those products there. So can you talk about the whole portfolio within north America as well as what the pipeline is Speaker 2 00:15:50 I line is? Yeah, no, absolutely. So, um, just as we've been talking, of course, um, Verium, you know, which, um, which we're launching now then, um, also, um, IVANS that we just, um, recently, um, um, purchased, um, I think they have a variety of, uh, different products they're treating, you know, from type of, um, um, to products two, for instance, uh, fresh coat, um, which is a, again, another, you know, great product for treatment of, um, dry eye. Um, so, you know, with, with IVANS, I think, you know, we've been able to bring a, uh, relatively, um, good portfolio to patients. And, you know, if we're looking at the, um, the pipeline per se for north America, um, one of the next ones that we're focused upon is in the treatment of glaucoma. Uh, we have, um, uh, hopefully we're gonna be resubmitting relatively soon. Speaker 2 00:16:48 Um, I BS we got there, unfortunately, our CRLs due to some, um, uh, external manufacturing issues. Um, but we're planning to resubmit that, uh, shortly and hopefully by the end of the year, um, get also an approval. So you have that, then you also have, um, other, um, compounds in the field of glaucoma coming up, uh, like for instance, Theatro, um, which is, uh, FP three, um, agonist, um, and then, um, you know, obviously, you know, longer down the line, um, as we mentioned previously, um, we, we are very much focused upon myopia. We don't necessarily just see that as a disease, uh, which we see predominantly, um, in, in Asia, but obviously that, that's also something that impacts us, um, in the us. So, so from that perspective, that's another, you know, uh, treatment options that we're hoping to bring, um, to the forefront, you know, uh, hopefully, um, uh, within the next, uh, few years in the us, but, but, you know, at the end of the day, what we're really trying to, um, aim for is to provide a broad base of, uh, different, um, therapeutics, um, to the patient also in the us. Speaker 2 00:18:06 Um, and, and that usually covers, as I've said everywhere, where we're active glaucoma, dry eye, um, and so forth. Speaker 1 00:18:14 Yeah. I mean, with, with the, uh, would bring on, I ance, I mean, this, that portfolio, I mean, cerate comes to mind right now, and right now as allergy seasons, I'm sure Tracy, you as well have been prescribing a lot of that, and it's been very effective yep. For our patients with the, with the itch and ocular allergy mm-hmm <affirmative> when we look at Flarex the broad indication that it has for patients with, with, uh, ocular surface disease, we have Tobradex SD, as you just mentioned, Peter for conjunctivitis and those patients with inflammation and, and just the irritation, but I'm gonna go back to PCA because we know it's cyclosporine 0.1%. Right. So are there any pipeline, is there, is, is that in the pipeline for dry eye or severe keratitis down the road? Speaker 2 00:19:00 Yeah, I mean, in, um, in Europe, actually we have, um, the same compound goes under, um, ICUs. We actually have that approved there for, for the treatment of, um, dry eye. So we, we we're considering, you know, different options of, uh, potentially bringing, um, something similar, um, to the us, um, still needs to talk to the agency about the best path forward, but, um, definitely something that we could be looking into. Speaker 0 00:19:28 So how do you continue to contribute to addressing the unmet needs of patients? How does Seton do that? Well, Speaker 2 00:19:39 Yeah, so, so I think, you know, one of the things that we've really, um, been pushing forward, just like many other companies, quite frankly, and perhaps we're just a bit late to catching up, but, um, it's, uh, utilizing of course, um, you know, patient advocacy to, to get that patient insights. Um, we're working very closely together also with, um, NGOs. So, so we have a collaboration on ongoing with, um, with Orbis. So trying to see, you know, through their work as well, getting those, um, additional insights. And then of course, you know, working very closer together with, um, academia, we have our research centers, um, across the world, uh, where we actually have the opportunity to, to get that, um, topnotch insights with regards to, you know, truly, um, innovative new pathways. And they're, you know, always based upon that unmet need of the patient. So it's a combination, right. I mean, both seeing the patients, but as well, also just doing more research, theoretical work Speaker 1 00:20:40 Mm-hmm <affirmative> Speaker 0 00:20:42 So how long have you been active with the United States? How long has Santon been here? Speaker 2 00:20:47 Yeah, so, yeah, so, so I think, you know, um, this is for the lack of better word, uh, kind of our, um, second attempt. Um, I think, you know, the, um, historically Santon was, uh, made a, a, a minor, um, entrance back in the early two thousands. Um, but, um, kind of didn't, um, have that pipeline, that depth, so to speak in, in order to be really, um, successful. So we've been, um, we've been at this of trying to get new compounds here, um, out on the market for the last, um, 10 years or so. So, uh, we're finally there, we finally made it, so we're very much, you know, grateful and very much looking forward to that. Speaker 0 00:21:30 We're all excited too. So thank you for making the jump over here. Speaker 1 00:21:34 Oh, definitely. And it's a great opportunity just with that portfolio that we were just discussing earlier. It, you know, getting the opportunity to work, you know, within, uh, with, with all the various, uh, the eyecare professionals with academia with, with various, uh, um, institutions. So to what extent does sand collaborate with industry academia and government in advancing its work, uh, overall? And can you provide some examples? Speaker 2 00:22:01 Yeah, so, so as I mentioned, I mean, we do try to particularly, you know, get that, those, um, um, patient insights and utilizing NGOs, because particularly, you know, with regards to, you know, working with government, um, I think that that always becomes a bit tricky, particularly in certain areas, uh, of the world. So we're trying there to work either through, um, certain societies or respectively, as I mentioned, um, any types of, um, NGOs, um, when it comes to, you know, um, industry, of course, we're very much, uh, supportive of collaborations, um, trying to, um, gather insights, uh, from potentially, you know, other, uh, players, not necessarily within ophthalmology, but just to kind of share best practices and so forth. And then as I mentioned, our could be from an academical perspective. Um, we have those collaboration, for instance, ongoing with the, um, Singapore I research, um, Institute, um, then also with, um, university of college in London. So really trying to, you know, tap into the, um, the great work that is happening in academia. Speaker 0 00:23:18 So do you have any localized home bases for Santa north America here? And, um, if so, where are those gonna be located? Speaker 2 00:23:29 Well, yeah, I, I, I presume you're asking, you know, our locations and, um, I mean, we are, um, our main area, um, our main headquarters in the us, um, is, um, the San Francisco bay area. Um, that's where been also the last couple of years then now most recently, of course, with the, um, with the integration of IVANS, we also have presence in Texas. Um, and then from previously with the, um, um, purchase of in focus, we also have some presence in Florida. So, um, yeah, tho those, those are kind of the, the main three areas where we're at Speaker 1 00:24:11 Peter, if any of our colleagues have any questions about, uh, any of the products, whether it's SIO or anything within the portfolio, uh, who can they contact? Speaker 2 00:24:22 Yes. And so, I mean, um, obviously first of all, um, I guess something they can always reach out to, um, our med info team. Um, they, they would be able to have that information, um, uh, or respectively, you know, you, you can always reach out to our core comps, uh, communication team. And I think, you know, they, they can also help, so, um, either or works, but perhaps starting up with med info. Speaker 0 00:24:48 So you have medical science liaisons, is that right? Speaker 2 00:24:52 Yes. Correct. I mean, you can also reach out, um, to them, you know, if you can get a hold of them, they're very, very busy <laugh>, but, um, definitely you can also talk to the, the MSL, um, but if you wanna make sure that you get a more quicker answer, I guess yeah. Medium for, um, communication, but MSL. Absolutely. Speaker 1 00:25:11 You know, I add another question that that just popped up. So what is the sales team right now? How big is it, how many team members do you all have throughout the country and north America? Speaker 2 00:25:22 Well, you know, from, from a pure, um, size perspective, um, can't necessarily comment on that, but we make sure that, you know, there are, um, enough, um, sales rep there to, um, satisfy the needs, uh, for visits, et cetera, um, from the physicians. So you can definitely count on we, we make sure that, uh, we're there. Speaker 0 00:25:45 Is there anything else you'd want our listeners to know about Santon, uh, north America in general? Speaker 2 00:25:52 Yeah, no, absolutely. I think, you know, one of the things that we talked about, uh, about, you know, what makes, um, Santon special, and one of the things that I'm really excited about is that particularly in today's, um, industry, you see so many companies kind of opting out of ophthalmology, um, for, for SC and this, this is our bread and butter. So, so we are here to say literally, so, so from that perspective, this is, uh, kind of what we're good at. This is what we're focused upon. Um, and we welcome any types of collaboration, you know, with, um, with, um, academia, with industry, with government, with, you know, physicians, uh, so patients, um, to, to get those, um, connections, to get that collaboration, um, ongoing, because we we're really, you know, keen on, um, ensuring that we can actually be providing, uh, good service. Um, so from that perspective, um, yeah, I mean, please feel free to, to, to reach out because we are really, you know, happy and grateful about this opportunity to be able to serve the, uh, the us market. Speaker 0 00:27:00 Thank you, Peter, for coming on the click on dry podcast today and sharing your expertise about Santon and their growing role in the us marketplace. Uh, thank you so much for your time and, um, sharing with our listeners about what's coming up in the pipeline and all the exciting innovations that are there that are gonna be in existence to help our future patients. Speaker 1 00:27:23 Thanks, Peter. Speaker 2 00:27:24 Well, thank you so much for having me really appreciated the opportunity to talk about San. Thank you.

Other Episodes

Episode 0

December 30, 2022 00:22:05
Episode Cover

Worlds Collide: Dry Eye and Ocular Allergy / Dry Eye Juice Box.

Interview with Josh Davidson, OD, FAAO from Williamson Eye Center in Baton Rouge, LA. Dr. Josh Davidson scratches below the surface of ocular surface...

Listen

Episode

June 15, 2021 00:23:32
Episode Cover

Addressing Dry Eye Flares: Early Anecdotes and Experiences with Dr. Adam Ramsey

Eysuvis, a new FDA-approved corticosteroid that is indicated for the short-term treatment, up to two weeks, of the signs and symptoms of dry eye...

Listen

Episode

May 04, 2021 00:16:16
Episode Cover

Dropping the Mic on Demodex: The Final Word by Dr. Bobby Azamian on Blepharitis

Dr. Whitley talks with Dr. Bobby Azamian, co-founder, president and CEO of Tarsus Pharmaceuticals, about a topic that we haven’t addressed before on the...

Listen