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Mark Altmeyer: Founder and CEO of Arvelle Therapeutics · BioBoss

• 0:00
  John Simboli: Today I'm speaking with Mark Altmeyer, founder and CEO of Arvelle. Therapeutics, headquartered in Zuf, Switzerland. Welcome to BioBoss, Mark.
• 0:09
  Mark Altmeyer: Thank you, John.
• 0:09
  Mark Altmeyer: I appreciate the opportunity to have the conversation with you.
• 0:13
  John Simboli: How did you find yourself here at Arvelle Therapeutics?
• 0:16
  Mark Altmeyer: I was working at a company that was focused on product for Alzheimers .
• 0:19
  Mark Altmeyer: Unfortunately, for patients, especially the products in our pipeline did not succeed in clinical trials. And so we started a significant effort for business development. The company I was at, ultimately did a couple of deals in gene therapy. So they really committed themselves to that area of medicine. But in our efforts to do our business development, we came across the product Cenobamate, which I felt was unique in the respect that it was highly differentiated against the market's greatest unmet need, which is more efficacy. And so, we put together a small internal team to really diligence, the opportunity and actually then move forward to gain the license as well as create the funding for the company.
• 1:16
  John Simboli: Several founders I've spoken with said part of the challenge when you're first starting up is to know when to quit looking. So as one looks, as you were, for the right opportunity and you saw it, was it clear enough that you said"Yeah, I know, this is where I want to go next" or is it a process of looking and looking and saying, "Yeah, I think this is it." How long does that take to figure out?
• 1:39
  Mark Altmeyer: in this particular case it was more self evident. And the reason I say that is I've spent years, as many in the industry have done, looking at different business development opportunities And you're always in that gray area, is it different? Will it be different? Will it be successful? When's the next data milestone? Do we wait till then or not? In this case, you know, the SK program, SK Biopharmaceuticals program, was really well developed. They created some really interesting efficacy data. And then there was a few questions around, OK, well, what are the regulators going to think? Do you have to do any extra clinical work? How would you actually commercialize this? Can it actually get a reasonable price in a market that's highly genericized? But for me, to actually have the efficacy question answered, to know that this drug had substantial differentiation, was already a huge way towards being comfortable that this was an asset worth going after and building a company around.
• 2:47
  John Simboli: And did you consider at any point, thinking, well, this looks like a really strong asset, maybe I'll take this to a big company, and I'll build it within their big company, as opposed to, I'll just have to start this thing from scratch.
• 2:59
  Mark Altmeyer: I think there were already big companies that were looking at it, I don't really have complete visibility into who was talking to SK at the time. So for us, it was much more of an opportunity to say,"Wait, this is a unique asset.
• 3:16
  Mark Altmeyer: There's a huge unmet need here, we can custom build an organization in Europe, just around the epilepsy opportunity." Naturally, we want to actually build in product two, product three, but to your earlier question, that's going to take us a little bit of time to figure out what fits. But what we really wanted to do was custom build an organization to take advantage of this opportunity. And for that reason, we felt we could actually do it, ourselves.
• 3:44
  Mark Altmeyer: Because the treatment patterns or treatment referral patterns in Europe for epilepsy are really well-defined. The actual number of treatment centers or specialty centers is relatively small. So it's a really concentrated footprint you need to have in order to get at the majority of treatment resistant patients and that's really our core business opportunity. We don't need a huge organization to go after that. So we really did feel as though we could do it ourselves.
• 4:16
  John Simboli: How would you say was the difference between what you thought it would be like to start and lead a new biopharma company versus your experience having been in some of the world's largest pharma companies? What did you think it'd be like? What did it turn out to be?
• 4:30
  Mark Altmeyer: The biggest change for me was just the range of things you need to do in a small company. You need to be thinking everything from three to four to seven years ahead. So you got kind of that high level strategic, but you also need to just get the PowerPoints done, get a presentation out to investors. Schedule some appointments with KOLs, We didn't have an admin staff and so you're really trying to prioritize across a much larger range of things. There's nobody to delegate to. So you really got to decide what's important, and how am I going to make this happen? And then focus on the right balance of short and long term things you've got to get done.
• 5:20
  John Simboli: What were you hoping to achieve at Arvelle, that couldn't be done at another company?
• 5:24
  Mark Altmeyer: The things that really stand out, as I think back on it, is, one, working on products that truly bring a differentiated advantage is really satisfying. If I'm going to be perfectly honest, I've worked on dozens of products, but there's probably only a couple that really made a significant difference. I think this is one that can do that.
• 5:47
  Mark Altmeyer: The second thing I think about is, you know, I worked on lots of different teams, led lots of different teams. But there's a few that really stand out. And they stand out because they were populated by people who I felt were really good, highly engaged, but also very collaborative, and very willing to just sit at a table, put titles aside and just have a really good debate about well, how do we optimize the situation for our brand? And it became less about the people or this or politics or how do I get ahead.
• 6:20
  Mark Altmeyer: For me the opportunity to start a new company, to have that as a guiding principle and to really recruit people and actually create that culture, it's just a lot more fun for me at this point in my career, where, I want to work, one, with people I really enjoy, and, two, with people who really want to help build something special here.
• 6:49
  John Simboli: In the New York area, of course, and other metropolitan areas, people say, what do you do for a living? And they really want to know, how powerful are you? How much respect should I show to you?
• 6:56
  John Simboli: And there's a great temptation to say, "I'm a very important person." So when you can get past that, and people say, Mark, what do you do for a living? How do you like to answer that?
• 7:07
  Mark Altmeyer: To me, it's pretty straightforward. What I do is I really help develop and commercialize medicines for people who really need improvements in their treatments. And the reason I like to do that is because at the end of the day, it's good intellectual work, it's stimulating, and if you're successful at it, you can look back and actually recognize that you have made a difference in many people's lives. And that's just personally satisfying.
• 7:38
  John Simboli: Do you feel that you have a management approach that works for you?
• 7:41
  Mark Altmeyer: I do think I've got a management approach that works for me. And to the first part of your question, it's constantly evolving, and I'm trying not to be too set in my ways. And particularly since, you know, dealing in Europe with a lot of individuals who come from a lot of different backgrounds and cultures, I think it requires a little bit more nuanced adaptive approach.
• 8:04
  Mark Altmeyer: But to me, the same fundamentals exist. One is to be collaborative, and be a good listener, to be accessible to people, to set high, but appropriate expectations in terms of what we want to do, and how we want to think through our opportunities and issues. And then lastly, really set out a vision, a set of principles, and then abide by those. At the end of the day, if I actually don't take either positive action and reinforce the good behaviors that are consistent with the vision and how we set up the organization, and conversely, confront issues when they arise and say, that's actually against the cultural principles we set up, then it's not going to work.
• 8:59
  Mark Altmeyer: So at the end of the day, it seems pretty simple. But it really requires, on a daily basis, staying attuned to all this stuff and again, balancing between which ones are really well in place versus which ones need some time and attention.
• 9:18
  John Simboli: I've asked several founders and CEOs, what, their self image was when they were young folks, little kids, actually, and I remember john Houston, for instance, saying, well, that's easy. I wanted to be a footballer. And a couple of people from the UK saying, I wanted to be a doctor because the doctor shows were on TV when I was a kid. So if you can remember back to being eight, nine, ten years old, something like that. Can you remember what your self image was, what you wanted to be when you grew up?
• 9:44
  John Simboli: Does it have anything to do with where your life took you?
• 9:48
  Mark Altmeyer: Not at all.
• 9:49
  Mark Altmeyer: And I'm more like john Houston in that, you know, I really wanted to be an Olympic athlete,
• 9:56
  John Simboli: Which kind of Olympic athlete did you picture yourself as being?
• 10:01
  Mark Altmeyer: So I was I grew up as a ski racer and was very focused on alpine ski racing.
• 10:10
  John Simboli: That would have been a pretty glamorous life.
• 10:13
  Mark Altmeyer: It would have been nice. And it was it was fun for a while till I got 21 and graduated from college and then, you know, all good things need to come to an end and I had some bills I had to start to pay.
• 10:24
  John Simboli: What do you say when people ask who is Arvelle Therapeutics?
• 10:27
  Mark Altmeyer: We're building a company that's going to be a specialty neurology company focused here on our opportunity in Europe, the goal of which is to, as our first initiative, bring Cenobamate for treatment refractory epilepsy, and simultaneously we're going to be looking for other products that we feel can really help address the unmet need that exists across the CNS spectrum.
• 10:58
  John Simboli: What's new at Arevelle Therapeutics?
• 11:01
  Mark Altmeyer: So the newest thing for us is that we filed our MAA. We're in the midst of our EMA review right now. And what that means is we're actively building out all the launch readiness, all the launch preparation, and frankly, our country organizations as well.
• 11:18
  Mark Altmeyer: And so we're well on the way to progressing to be prepared to take the product to market. If we have a successful MAA review,
• 11:31
  John Simboli: When you tell people the Arevelle story and you realize that they've heard something a bit different than where your vision is, what do they mis-hear? And how do you go ahead and say, OK, let me let me try to explain that?
• 11:44
  Mark Altmeyer: I think the biggest thing is when people think about Europe and the possibility of building a successful business in Europe.
• 11:51
  Mark Altmeyer: And what I mean by that is everybody wants a product in the U.S. market. Obviously, pricing is better. There are certain payer challenges, obviously, launch challenges in the U.S., but I think those are all magnified here in Europe. And I think people just, if they get stuck, they get stuck on trying to understand why would Cenobamate actually be able to compete in a marketplace that's got a couple dozen products that are, probably at least 20 of them, are generic. So why is this different than diabetes or lots of other categories where I've seen branded products not do well. And so we walk them back through how we actually got comfortable during our due diligence, how we then made our series A investors comfortable, how we've continued to refine and build down the hypotheses that we had, about why we can actually build a profitable business around Cenobamate in Europe, despite the challenges.
• 12:54
  Mark Altmeyer: And the fun part is being able to try to turn people's views and understandings around so that they really do see why we were able to create the opportunity in the company Arvelle.
• 13:12
  Mark Altmeyer: I think there's three reasons why things work for us specifically here. First of all, the level of differentiation, for Cenobamate, particularly on the market's greatest unmet need, which is efficacy, is amazing. In my 30-plus years in the industry, I've just never seen a product this well differentiated against the market's greatest unmet need. So what that means is at the top line you're going to get, and we've seen this in our market research, really high intent to use, so high penetration rates.
• 13:46
  Mark Altmeyer: On the flip side, when you look at the treatment referral patterns, it's really concentrated in Europe. So there's a very defined set of Centers of Excellence or specialty hospitals that treat the more refractory epileptic patients. So we don't need a big commercial footprint. And then the third thing is when you look at brand new prices of anti-epileptics in Europe, it's clearly a fraction of what you get in the U.S. But even if you use those prices, your P&L works really well, because your high penetration rate and your smaller commercial footprint.
• 14:29
  Mark Altmeyer: And obviously we're going country by country to try to figure out how can we get a premium price because we think if there's ever a product that deserved it, it's Cenobamate, because it really brings distinctive efficacy and new hope for seizure freedom to patients.
• 14:48
  John Simboli: How does the pipeline at Arvelle distinguish who the company, what your vision is?
• 14:54
  Mark Altmeyer: So right now, our first focus for the year was really just in getting our MAA applied to the EMA, which we did in March. So now the company is morphing to two different areas.
• 15:08
  Mark Altmeyer: One is, there's a number of non-epilepsy indications that may be good opportunities for Cenobamate. There's a strong mechanistic rationale and some really interesting non-clinical data that suggests that there may be opportunities. So we're actually taking a look at what further clinical work is justified in those different indications. Separately from that, we are looking at, we've compiled our hit list of neurology or CNS products that have been developedthe clinical risk has been brought down, the regulatory risk, in many cases have been brought downhas not been introduced in Europe. And therefore, as we set up a commercial operation, calling on all the key CNS hospitals across Europe, perhaps there's a really good mix. And so we're beginning to have those kinds of conversations. But at this point in time, we don't have anything specifically in the company to point to, but we clearly want to build out and have products two, and three and four,
• 16:17
  John Simboli: What kind of partners make a good fit to Arvelle?
• 16:20
  Mark Altmeyer: We're working very closely with some of the advocacy groups, obviously, the KOLs, some of the experts in the epileptic area. So those kinds of partnerships are really important to us. As we think about additional pipeline products and assets, finding additional partners who recognize the strength we can bring to them with the European commercial focus, recognizing the development capability we've got in Europe, as well as the commercial strength, would be good. And so partners who don't have that, you know, there's really potential nice synergy there. And I think the third thing is just myself and my two other co-founders came in with, I've got an extensive commercial background, my CMO has an extensive development, regulatory background, and my CFO has extensive financial backgrounds. And so between ourselves and the teams that we've all built it, we think we can offer a lot of expertise on some of the key aspects that smaller companies may not have.
• 17:30
  Mark Altmeyer: And therefore, we could be a really good partner and flesh out in the areas that you need to be successful in the biopharma industry.
• 17:43
  John Simboli: When you're building your team within Arvelle, what kind of people thrive, what's the culture that is the right mix?
• 17:52
  Mark Altmeyer: It's people who have a demonstrated track record, achievement oriented, but are collaborative, are good listeners, have the diplomatic skills to be respectful of individuals so that we can actually get into a position where we can have some really significant disagreements if we need to, but it doesn't enter into the personal level. It's just, I really don't agree, John, with how you're thinking about this, I think the world works this way. Therefore, we should have a strategy or, we should invest our money that way. I hope we can really mix it up and ultimately out of that process come out with what we think is the optimal path forward for us. And so it's people who really come in prepared, they take accountability for what they do, but they're also willing to understand and enter into that kind of debate and dialogue.
• 18:52
  John Simboli: So at this stage, you're entering a very hopeful stage in the development of a company, Is the focus so immediate, and so precise at this point on these next steps, that the opportunity is here now or someday in the future, to sit back for a moment, perhaps on a weekend and say, you know, if this Arvelle develops way, I hope it will, I'm really going to do some good in the world? Or is that something you say to yourself, I know it will, and I'll think about that later.
• 19:25
  Mark Altmeyer: No, I think it's it's actually a piece of the daily motivation. And the way we connect with it, a lot of the work we've done in the past year is reach out to the different investigators. And what's unique about the program that SK ran in their development is it was very sequential in nature. And so the investigators themselves had a lot of open label experience, which is really unique. I'm used to a world where, you know, you finish up your double blind studies in parallel, you run off and file as quickly as possible.
• 20:00
  Mark Altmeyer: Your investigators are trying to guess who was on active who was on placebo. You have those conversations, but they're not necessarily as tangible and concrete as they have been in this situation.
• 20:14
  Mark Altmeyer: And I think the stories we've continued to hear are things like, well, I've been doing trials in epilepsy for 20 or 30 years, this is the best drug I've ever had in trials, let me tell you about patient x, or patient y, or patient z. And you just get really excited about the opportunity Cenobamate has.
• 20:34
  Mark Altmeyer: So we do pause to think about that. We'd love to have KOLs talk to us, or reach out to them or present at team meetings to help energize folks. But I also think, longer term, it'll be super energizing, once the product's out there and we get a chance to have this broadly used across the population, to hear feedback from the marketplace. I mean, I still remember some of the letters I got from patients across the U.S., across the globe, Latin America's one, for example, on Abilify who commented that it was the first time she had enjoyed the holidays with her family in 15 years, because she'd been put on Abilify and it actually really worked for her and helped her.
• 21:22
  Mark Altmeyer: And she was just so thankful to the company for what we did, and all of our efforts to make that product available to patients like herself. So there's a short-term motivation and energy we need to get from people who know the drug. And then there's the the long term hope that, you know, in five years, we can sit back and say, OK, we really did help the standard of care and the treatment of epilepsy, and therefore, hundreds of thousands and and obviously, if we're super successful, a million plus patients with treatment resistant epilepsy,
• 21:57
  John Simboli: Mark, can you describe the scope and the impact that the work that you're doing, can have on patients in Europe?
• 22:04
  Mark Altmeyer: We estimate that there's 1.6 million treatment resistant epileptic patients across Europe. And for us, that breaks into three main categoriesfocal onset, which is our first indication, there's about a million there; then there's generalized, now that's a different epileptic condition but we already have a study ongoing, and we expect to be able to file for that in early'23. And then there's a bunch of smaller, either pediatric or orphan epileptic syndromes and those are interesting to us, because the molecule may have some activity in that area. But we've got to explore that. For us, we actually think our core focus should be on the the focal onset, and then the generalized patients. And if we're successful, that's that's how I think our company can ultimately help the epileptic patients across Europe who've got treatment-resistant disease, and that's how I come up with an estimate that it could be hundreds of thousands or if we're super successful, maybe even over a million patients could benefit from our efforts to bring Cenobamate to the market.
• 23:20
  John Simboli: What's it like for someone born and raised in America to be heading a biopharma company that's based in Europe?
• 23:26
  Mark Altmeyer: So the challenges I face are, you know, it depends on who you're talking to. And you can see some cynicism based on who it is you're talking to.
• 23:37
  Mark Altmeyer: And what I mean by that is, there are other industry partners who've commented that we're not going to know the market, because we're an American, and we haven't been born and raised in it. And in my response is that's why all of our hiring has been focused on people with deep European experience. So the commercial team, the regulatory team, the medical affairs team, you know, everybody's European, because we all share at the foundation, the desire to work on a drug as good as Cenobamate. I also think there's some cynicism about just, well, here's a couple of Americans have put together a company to try to make some money here in Europe. And if that's how they want to think about it, they can. You know, at the end of the day, I've just been doing this a long time, I really get a lot of satisfaction out of bringing good products to the marketplace. And my belief is if you bring good products, and you do a good job, and the market accepts your product, out of that falls a really nice business, and I'm actually geographically agnostic. Turns out the opportunity existed in Europe. The product was great, so it's kind of like OK, let's put those two together. I wasn't really thinking about anything else on those dimensions. But to your point, you know, sometimes you just got to be ready to deal with some people who look at you a little bit differently. Though Zug is a very international, small little town, it's right next to Zurich, which is also a very international city. And for the most part, it's not been an issue that I've had to deal with.
• 25:32
  John Simboli: What's it like to face the challenge of working in an industry where the answers to questions are not clear, sometimes the questions themselves change all the time?
• 25:41
  Mark Altmeyer: You know, in most cases I've been involved in, you know, if your products really good, the good comes through.
• 25:50
  Mark Altmeyer: You know, at the end of the day, the market finds out the truth about your product. So I'm not afraid at all to tell people up front, here's the things you got to know, here's the good, here's the bad, here's what you got to get ready for. But at the end of the day, you put all that together, there's a really nice home for this product within the the treatment algorithm for epilepsy, for example. And you know, over time, you just peel back one risk, two risks, three risks, four risks at a time. And yeah, you've got to, hopefully just make small, little course adjustments. Sometimes they become major. And that's just the nature of the industry we're in. But the good news is if you get out the other end and you get into commercialization, then you've got the opportunity to actually see your drug get used and hopefully help a lot of patients.
• 26:41
  John Simboli: Mark, in what ways is Cenobamate made different from other drugs?
• 26:45
  Mark Altmeyer: You know, the thing that really caught our eye was actuallyto really simplify the whole thingis just the the rate of seizure freedom that came out of the clinical trials.
• 26:57
  Mark Altmeyer: It really had a very high rate of seizure freedom in patients who were in the treatment resistant category. And we think, for that reason, this brings new hope to patients who've been unable to get seizure free with the dozens of available meds that are out there right now.
• 27:14
  John Simboli: How do you deal with the complexity of bringing an innovative drug into the marketplace in Europe?
• 27:21
  Mark Altmeyer: I think back on drug launches I've had in the US, which you know, you've got your own set of complexities, I think Europe's even much more complex. And what you really need to do is break it down into what are the countries going to need to launch? What are the countries is going to need to optimally price your product?
• 27:41
  Mark Altmeyer: And you have to go country, by country by country. And it ends up being each individual country is unique and different in its own special way. And so you really have to be prepared to spend the time to understand the details of their process, their country, the nuances that you need to put in place and how to adapt your core plans. And you've just go to be ready to embrace the complications and the extra work required to do that. You can't just come up with a pan-European strategy.
• 28:18
  Mark Altmeyer: It's country, by country by country. So you just get ready to find the right people who can help you find those right country nuances. And you just put the time in against your key priority countries.
• 28:33
  John Simboli: When people ask, How can Arvelle take this on and bring this forward? How do you like to answer that?
• 28:39
  Mark Altmeyer: So for me, that's a question we had to answer for ourselves. As we were even thinking about putting the company together, you know, is this something we could do?
• 28:49
  Mark Altmeyer: Because at the end of the day, I want to build a company that actually pulls it all the way through, through commercialization. With the focus of Cenobamate made on the treatment resistant population, with a small universe of specialist centers across the EU, 20 that we need to focus on, the actual size of the organization we need, we've done a lot of work to estimate what that is, is actually relatively small. And for that reason, I feel very confident that we'll we'll be able to find the people to stand up this organization.
• 29:33
  Mark Altmeyer: Being essentially a year and a half into it, the good news for us is the people we talked to, who actually want an entrepreneurial experience versus a big farmer experience, when they see the quality of the asset, they also get excited about it, and they see that this presents a good opportunity in the right time for them to actually potentially move from a large or mid-sized company to a small startupone, to give them that experience, two, to help paint the whiteboard and flesh out what the organization looks like. But also with the the comfort and the confidence that we've got a great asset to bring to the market.
• 30:19
  John Simboli: Is there an issue?
• 30:19
  John Simboli: Is there an initiative within the biopharma community that's especially important to you that you would like to share that?
• 30:30
  Mark Altmeyer: I probably tend to be an optimistic person to begin with. I've been in the business since the 80s. And the progress we've made in understanding biology, developing new drugs and new approaches is just phenomenal.
• 30:49
  Mark Altmeyer: And I think that is going to continue. My hope is that we we figure out some way to ensure that whole innovation engine continues, because in another 20 years or another 40 years, millions of people will benefit from that process. And I would just hate to see that short-circuited somehow in us not to be able to figure out how, as a society, we're going to pay for innovation, because I'm just so impressed with how much innovation we've had, and I really want to see it continue.
• 31:27
  John Simboli: Thanks for making time to speak with me today, Mark.
• 31:30
  Mark Altmeyer: Well, you're welcome, John. Thanks for the opportunity to speak with you and all the thoughtful questions. Thanks so much.