Novaliq’s Positive Phase II Dry Eye Results Present Break from Disappointing Clinical Trial Season
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Christian Roesky, PhD, joins the OIS Podcast to explain why he became the new CEO and managing director of Novaliq GmbH, a specialty pharma company with a novel drug delivery platform technology that can make drugs more effective in treating ophthalmic disorders. He also delves into the company’s positive Phase II evaluating CyclASol in 207 patients with moderate-to-severe dry eye disease.
Tom Salemi: Hi there, Tom Salemi here. Welcome back to the OIS Podcast. Thanks for joining us. We’ve got so much to talk about. It’s a huge week in healthcare obviously. It’s JP Morgan week, and I am not there. This is the first time I’m not there since it’s been JP Morgan. So I might have missed one time a decade or so ago when some child got sick. But did not make it out this year. We’re going to talk to folks who have been out there, including our guest today, Dr. Christian Roesky. He’s the Managing Director and CEO of Novaliq. We’ll talk to Christian a bit about JP Morgan and try to find out some more about anything else that’s gone on out there this week, but it’s been a pretty quiet week for ophthalmology, pretty noisy elsewhere, particularly on the political front. Just got done watching President-Elect Donald Trump’s first press conference. Obviously made an interesting proclamation about bringing bidding to drug pricing in the US. So that’s something we’ll have to follow up on. Going forward, not sure if I’d ask Dr. Roesky to weigh in on that issue just yet, but I do want to talk to him about Novaliq’s great news. It had positive phase 2 results evaluating CyclASol, its cyclosporine solution for the treatment of moderate to severe dry eye disease. They had some positive results, and I’ll talk to Dr. Roesky about that, about what those results mean for CyclASol going forward, and also what the broader plans are for Novaliq. This is the first opportunity I’ve had to speak with Dr. Roesky. Previously, I’ve been speaking with the former CEO, Bernhard Guenther, who’s now the Chief Innovation Officer. Talked to Bernhard actually just this past October at OIS@AAO. So very familiar with Novaliq, but they brought in Dr. Roesky, who has worked in many, many different capacities in ophthalmology and pharma, including a recent stint at Bausch and Lomb. He’s been with Abbott, he’s been with Alcon. So this is really an interesting move for him, and I definitely want to talk to him about what brought him to Novaliq. So should be a great conversation. Hopefully, we’ll hear a little bit about JP Morgan. We’ll hear much more about Novaliq, and probably not a lot about Donald Trump. So please enjoy this conversation with Dr. Christian Roesky.
TS: Well, Christian Roesky, welcome to the Podcast.
Christian Roesky: Thank you, Tom. Thank you for the opportunity to speak to you.
TS: It’s great to have you and to live vicariously through you. I’m not at JP Morgan this year, and it’s the first time in a long time. I can’t say I miss it entirely, but certainly there is a lot of activity and bustle there. Given your background, and we’ll get into that a bit, have you been to JP Morgan before? You’ve had some senior management levels in several big companies. Do they require you to go to make the pilgrimage to San Francisco in January?
CR: Great question. Actually, I was always sitting on the buyer side. But or for buying companies, assessing them. So being at particularly at Alcon and later in Novartis, we looked at companies more from a strategic partner view. So I gave recommendation for commercial and obviously for strategic fit. But I left, you know, the JP Morgan to senior executive team to present the pathway of the companies at that time. So yes, you’re right. For me, now stepping into a new role as CEO in Novaliq, that’s the first time attending JP Morgan. And I can tell you it is exciting and you missed something.
TS: And what has your week been like? Because it just – I know no one actually goes to JP Morgan. It’s just the meetings around it. I imagine given your clinical trials, which we’ll also get to in a moment, you’ve had some invitations for some meetings.
CR: Well, we have been very fortunate because of the meetings we came at the time when we had very positive data to present, you know, that we had just right in front of JP Morgan published our top line data on the CyclASol clinical trial, where we were investigating dry eye disease for severe and moderate patients. So this obviously kept us really busy for both investors and potential partners. So it’s still in the middle of the progress, but I would say at that point I’m very happy with the proceeding of the meeting.
TS: That’s terrific. Well, we’ve kind of broken the ice on the clinical trials, and it is the news of the day. You released the results last week. What were the results? Can you share them with our listeners? And what’s next? What’s the significance of these results for you?
CR: Absolutely. So just remind the audience that we were running a phase 2 clinical trial on evaluating CyclASol. That’s a cyclosporine formulation in a very innovative formulation, EyeSol. That’s a water free presentation. Water free, preservative free. And we were looking into moderate and severe eye disease. And I think the results are really exciting in two aspects. One is we were predicting some of the outcomes with our preclinical models, so the outcome was really very fine. The platform of the EyeSol drug delivery technology that we have been predicting is now clinically validated. And obviously what you want to achieve in a clinical trial as well is that you want to hit the primary endpoint. And so we did this here as well. And as we looked at this study into an active control as well, we found that we are – have an earlier onset of action. So looking a bit more deeper, what we have been doing, this was a phase 2 randomized, double masked, vehicle controlled, multi-center US clinical trial. And we had four treatment groups with basically 50 patients each. Two groups were CyclASol, groups with different concentration, 0.05 and 0.1. And then with an open label active control and the placebo vehicle control. And we were running the study for four months with interim time points, and we looked at obviously both signs and symptoms. So as an outcome, we were very excited about it. Both CyclASol groups showed a significant improvement in the cornea staining compared to vehicle over the four-month treatment group. What was even more exciting is that the data really indicated an earlier onset of action in the cornea staining and conjunctival staining was as little as two weeks. So 14 days. We compare this to the products that are already on the market. That’s really significant. On the other hand, I was very pleased to see that the safety profile of the product was very good because both active concentrations really showed excellent safety, tolerability. The comfort profile was more than 98% of the enrolled patients completing the treatment period, and no adverse events. So this is a bit underlined. There were some thoughts on hypothotics a thesis that cyclosporine may imply side effects, but we cannot really confirm that with studies. So in our presentation, this product works very well and is pretty safe and comfortable.
TS: We’ve seen some other progress, obviously, in the dry eye space. You know, Xiidra of course getting approval last summer and some movement with other programs as well. How is that helping or affecting your program at all? Is there a lot more interest in what you’re doing? Obviously there was interest before, but does the taste of success sort of get people more excited about programs like yours?
CR: Yeah. I think Xiidra or the situation when I look at Europe with other products coming into the market like, I mean it really shows that there’s a high medical need for innovative, fast acting and effective treatment, and at the same time safe. So patients are waiting. And so these results are very promising from our point of view. So we will really move quickly and sit with the FDA and the IMA to discuss the next pivotal study. And obviously we are very excited as we can basically confirm our expectations respect of market authorization in the United States that we were targeting at the end of 2021. So on the other hand here, we are not looking only in dry eye. So we are looking into dry eye, glaucoma and retina. So it was very exciting to see that our platform really works, not only from a comfort point of view that we have established with another presentation, NovaTears, that is on the market already in Europe, but we really confirmed the drug delivery properties. So this obviously encourages us really to develop highly relevant therapies beyond the dry eye space into glaucoma and retina. However, you say, you are absolutely right. Dry eye, I would say, is our key priority. We have very high interest in programs that are running into the dry eye space. In particular, NovaTears, the product that is being already marketed in Europe, we want to bring to the United States. We are very well advanced here because we already have been sitting with the FDA. We know all the requirements, and we are anticipating that in the first half year of 2017 we will sit down and file for a pre IND. So that’s obviously very exciting. And then we don’t have a one shot when it comes to dry eye, but we could launch in the range of ‘20, ‘21, ‘22 a couple of products in the dry eye space that are clearly differentiated in the patients they are targeting and in the mechanism of action.
TS: Do you feel that enthusiasm for the space in the meetings you’ve had this week amongst buyers or potential partners? Is the momentum that we’re seeing in other areas with other companies in dry eye, and across ophthalmology, I suppose, is there – how would you characterize the appetite or interest in ophthalmology amongst the folks you’ve had meetings with at JP Morgan?
CR: Absolutely. When there was one player in the market, I mean there was dry eye was a bit silent. Now with Xiidra, obviously the interest and people are looking much more into detail. A little bit of my observation. So everybody is very excited because Xiidra had a pretty fast take up in the US market. It seems to be that they can address new patients. So both investors and partners, some potential partners I’m talking to, they look into both – in two areas. One is obviously this market needs differentiated products to protect premium pricing and value creation. On the other hand, there are a lot of patients out there that are currently not treated for multiple reasons. So really the need for an effective, fast acting, innovative approach in dry eye, I would say, is even further increasing having now two products on the market in United States. I think it’s a very exciting space that deserves to take a lot of attention from investors and in the ophthalmic community. And this is being confirmed by the scientific advisory board that we have been building over time in order to have both medical doctors, like Professor Tsubota in Japan or Claus Cursiefen in Germany. But industry leaders as well with Michael Stern, who was formerly serving for Allergan or Jerry Cagle formerly being the Chief Scientific Officer at Novartis. They are really encouraging us to continue and bring further products and evidence in this area of dry eye is really very deservable and patients are waiting.
TS: Hey, everyone pardon this interruption, but I did want to remind you that our first OIS of 2017 is coming up on May fourth. It is of course OIS@ASCRS. It is happening at the Sheraton Grand Los Angeles, and registration is open. So go to OIS.net for more information about the event, about the venue, and of course to register. So we hope to see you in Los Angeles. Now back to this conversation.
TS: You mentioned at the start of the interview that your most recent experience has been sort of on the buyer side of things. Tell us a little bit about your background. Your passport in ophthalmology, I think you’ve punched most of the big tickets. You were at Alcon and you were with Bausch and Lomb before this. What were you doing for those companies, and how is it now sitting on the other side of the table, having – I’m not sure if you were talking to buyers, but sitting on the side of the table of the smaller company, looking for a deal with a larger company? How was that transition for you?
CR: Yeah, it’s really exciting time for Novaliq because they own this disruptive technology that are currently confirming here, overcomes all the limitations of water. And I got really excited about it. You’re absolutely right, Tom. And I bring new skills to Novaliq, and I see myself that I’m completing a team at an inflection point. So what I bring to the table is I’m a healthcare executive. I have a background in chemistry, so that we fit very nicely with our platform. And this year actually turns 20 years of experience. I started at Abbott, then I served many, many years, almost 14 years at Alcon, made the integration to Novartis, Bausch and Lomb. And my background is marketing and sales in the beginning, and then I moved to a more strategic role. I work with the executive team. I looked into BD opportunities, market access, and the last years I’ve spent at Alcon and Abbott and Bausch and Lomb in general management. So in all my positions, I was really focusing on transforming organizations. And I think that’s the key. People make the difference, and the team here at Novaliq is very strong. So I hope that I can bring some experience from my past experience in the more sized pharma now to this fascinating specialty pharma company.
TS: What was it that drew you to this opportunity? Were you looking to join the startup world? Or just to sort of come over the transom to you and seemed like an exciting opportunity?
CR: Actually, that’s a great question. No, I thought I would stay in the sizeable big pharma company. Then I was approached by Jerry Cagle and he told me about Novaliq. And I met very quickly with the board and the management team. I got really excited because when do you have the opportunity to really touch something that is disruptive, that is basically challenging all what we know? I mean all eye care presentations are based on water, and we are going to a water-free, preservative-free formulation that opens really new avenues and gates. And what excited me is why was – there was a lot of confidence that this is going to work because Novaliq, when I talked to them already last year, they had already validated their technology in multiple ways. There were a lot of preclinical data. There were early clinical data for NovaTears, CyclASol phase 1 study was there. And they had a product already on the market, so the proof of market was with NovaTears already there. And then I met the people. I have to say they are really great. Great team, passionate, professional, and diverse. So really an organization has a plan in place, and matured so I would say it’s not any longer a startup company, but they really have a plan. We know what are the next milestones; we are very focused. So really a mature organization. And last but not least, I have to admit that the strong commitment from the community. Obviously Jerry Cagle who I know and for many, many years was obviously very convincing to me. But I looked at the financial foundation as well, having a highly committed family office. Dietmar Hopp with his investment platform, dievini, standing behind Novaliq was obviously very convincing as well. And then talking to other renown international faculty members on their advisory board, both industry medicine really competed the need. So I said yes, that’s the right time to make a big step for me, and hopefully we make big steps for Novaliq in the future.
TS: Well, that does lead into my probably next to final question: the future. We talked a bit about CyclASol and what might be next for that product. You mentioned the others as well, and those are all in earlier stages of trials. What are the next to-dos on your clinical trial list? And where are you with financing? Do you anticipate raising some money this year or next? Will that be necessary?
CR: So great question. We all know that the space we are in is great. Eye care, you know, with the three leading indications adding up to more that 12 billion annual sales, and with a great growth trajectory over the next coming years. I think that’s a great space to be. And Novaliq really has the potential to transform the ocular therapeutics, make a big difference to patients and to their vision. So what are the next steps? I mean for me, they’re very clear and defined is we have with our EyeSol technology really the opportunity to open a new gate to customize optimal drops. So this is encouraging us to continue obviously in the space of dry eye. But we are now putting a lot of effort into glaucoma and retina, which is really resonating, not only with our current investors, but with future investors as well. So what has been changing fromm 2016 to 2017? We will run now multiple clinical and preclinical programs in the three spaces, dry eye, glaucoma and retina, in this year. So that’s the major change. On the other hand, we could show that we can deliver because our fast and proven drug development process really increases success and time to market. And I would say we really are an attractive specialty pharma opportunity that has a strong pipeline for a wide range of industry partners and investment. Being saying that we are very well financed, so being here at JP Morgan, my intention is not that I’m looking for additional funds for future programs. Obviously all do that. What I’m talk to my current investors that I would like to enlarge the platform of investors. I think an investor that is being based in Germany, obviously would be European investment, mainly is good, was good for the last ten years. Moving forward, having more programs in the United States, or even looking for partners that would serve these markets from a commercial point of view, I think it is advisable mid-term that we are enlarging our investment base and allowing Anglo-Saxon investors to join this successfully.
TS: Great. Well you’re in the best place, I think, to begin those conversations. I’m wondering when President-Elect Trump announced his intentions to change how Medicare pricing works and introduce bidding, if there was a collective shriek at JP Morgan, if you could feel the change in the air, if it was palpable or if things are still humming along at the same breakneck pace?
CR: Well, you know, I heard about the interview this morning. But I think the healthcare industry believes if we focus on what really is happening to patients, we’re on the right track, and we will be in the United States and we will be globally. So if we continue doing this, and I have a high confidence that we are doing that, then I think we need to address to the audience, to the community that we are charging prices for products, but they are providing value to patients. So we need to do a better job in communicating that. But on the other hand, I believe healthcare is really a sustainable business, in particular the eye care indications, retina, glaucoma and dry eye really are an important space with a high unmet medical need, Tom.
TS: Amen. Well, I hope you can help you tell that story at an upcoming OIS. I look forward to meeting you there.
CR: Absolutely, we have to.
TS: Take care. Thank you for the time and enjoy the rest of the conference.
TS: Well, that is a wrap. Thanks for joining us, Dr. Christian Roesky of Novaliq. It’s great to hear the company’s progress with CyclASol. Look forward to hearing about its many, many more programs going forward and seeing it at an upcoming OIS. Thanks of course to our OIS Podcast listeners. Ask a few favors of you. If you enjoy this Podcast, go to whatever platform you listen to this podcast and just give us a ranking. We would love to hear how we’re doing, to see how we’re doing, add some comments. And of course tell your friends. If you’ve got colleagues who really enjoy what we’re talking about, innovation in ophthalmology, then please let them know about the Podcast. The more listeners we have, the merrier. Finally, if you have some thoughts on issue we should be talking about or people we should be interviewing on the OIS Podcast, please just do send me an email. My email is firstname.lastname@example.org. Healthegy is spelled the word health, followed by the letters EGY.com. Healthegy is the producer of this Podcast and of the OIS Conferences. Again, love to hear topics we should be talking about, guests we should be interviewing. So I would appreciate help in that regard as well. Finally, don’t forget May fourth at the Sheraton Grand Los Angeles. We’ll be having OIS@ASCRS. Registration is open, so go to OIS.net and we’ll see you in Los Angeles.