Hello everyone, welcome to today's seminar where we're joined by AlzeCure Pharma . I'll hand over to you, Martin, for the presentation.
Thank you so much. Good afternoon, my name is Martin Jönsson and we are here to present to you a seminar on AlzeCure's pain asset, Painless ACD 440, a presentation under the title ACD 440: A Novel Non-Opioid Analgesic with Orphan Designation. Today's presenter will be AlzeCure's Chief Medical Officer, Märta Segerdahl. Märta has a long career within the pharmaceutical industry and before that, within academia as a pain specialist. Today we also have the pleasure to have Dimitrina Dimitrova, who is a business consultant and also from Karolinska Institute, who has done a lot of work within the area of orphan. You also have me, Martin Jönsson, who is the CEO of AlzeCure Pharma and has been with AlzeCure for about six years. Today, the agenda for our session is ACD 440 and the opportunity within orphan.
We will go through a presentation on the orphan drug market, past, present, and the future, presented by Dimitrina Dimitrova. After that, we will dive into our pain asset, ACD 440, and the opportunity we now have within the area of erythromelalgia. We will go over to Q&A, where you will be able to send in questions that we can answer, and then we will have some final remarks. First, we will have a short introduction to AlzeCure. If we look at AlzeCure, we are focusing on pain and Alzheimer's disease. We are a spin-out out of AstraZeneca. When AstraZeneca left the CNS area, researchers from Astra founded AlzeCure. We have been sponsored by the Swedish Alzheimer's Fund. We are based in Stockholm at Karolinska Institute. We are developing small molecules. We have multiple small molecule candidates, which are first-in-class properties.
We have one project, one platform, which is Alzstatin, which is a preventive disease-modifying treatment against Alzheimer's to see to it that individuals do not develop Alzheimer's. We have NeuroRestore, which is a symptomatic treatment to help individuals who have cognitive disorders to improve their learning and memory capabilities. We have the platform Painless, where we have two pain assets, of which one we have ACD 440, which we will focus on today. As a company, we are listed at Nasdaq First Premier Growth Market here in Sweden. Our business model is that we are a research and development company. Our goal is to out-license our projects and to out-license projects to finance the other projects that we keep in our pipeline. If we look at our pipeline that we are having, we have our three platforms.
In NeuroRestore, we have ACD856, which is a positive allosteric modulator to improve learning and memory capabilities, where we focus on Alzheimer's disease, and we have a positive phase I readout. We have also, during this spring, gotten a grant from the European Innovation Council, who are co-sponsoring our planned phase II study. In Alzstatin, our preventive treatment against Alzheimer's disease, where we have a gamma secretase modulator, we have a lead candidate, ACD680, which we now are preparing for phase I. In the Painless platform, we have ACD440, which is a TRPV1 antagonist, where we are working on the indication neuropathic pain, as well as pain in erythromelalgia. We have a positive phase II readout in a chronic patient with peripheral neuropathic pain. Now we are heading in towards erythromelalgia. On ACD137, we have the TrkA-NAM assets, where we are focusing on osteoarthritis.
Here we are preparing these assets, ACD137, for clinical trials. In the platform Painless, with ACD440, which is a topical TRPV1 antagonist, we have initially been focusing on neuropathic pain, which is the biggest individual area of pain disorder with more than 600 million patients. In this area, we are building on science around TRPV1, which has been awarded with a Nobel Prize in 2021. Recently, this summer, we received orphan drug designation for this asset for the indication pain in erythromelalgia. We have also, from the FDA, received positive feedback on a potential registration trial that we now are preparing for pain in erythromelalgia. This is what we will be focusing on today. What we now will be doing is that we will listen to Dimitrina Dimitrova on the orphan drug market, past, present, and future. I hand over to you, Dimitrina, please.
Thank you for the introduction, Martin. And good afternoon, everyone. I'm delighted to share some insights from my master's research at Karolinska Institute, where I choose to explore the global orphan drug market. In this broadcast, I'll take you through why it matters so much for the patients and why it has become such an important focus for pharma and investors. Now, let's begin with some fundamentals to understand the market. Orphan drugs, per definition, are medicines that develop specifically for rare diseases. However, the definition of rare depends on geography. In the U.S., that means conditions affecting fewer than 200,000 patients, while in the EU, the threshold is fewer than five in 10,000 people. Traditionally, medicines have been developed for millions, even billions of patients worldwide, while orphan drugs focus on much smaller patient groups.
Within this space, there's even a narrower category of ultra-orphan diseases, which are affecting fewer than 6,000 patients. However, there's also some unofficial definitions. These very small populations are explained by the nature of their conditions. They're usually very severe, life-threatening diseases with no existing treatment options, representing an area of high unmet medical need. However, regulators have responded. Today, FDA reports that over half of the newly approved medicines are exactly orphan drugs. Despite this progress, it is known that it's almost less than 5% of rare diseases have an improved treatment, which creates urgency for patients and families who have no therapeutic options. While at the same time, fueling fierce competition among companies since being first to market often means years of exclusivity, premium pricing, and dominance in a high-value niche. This urgency, competitions are reflected directly into the market explosive growth.
In 2024, the orphan drug market has reached $195.2 billion globally, which is already accounting for 12% of all prescription sales. This market is also highly concentrated in the United States, where it has generated more than 60% of the sales, followed by Europe and the rest of the world. What truly sets apart the orphan drugs is their momentum. While the broader pharmaceutical industry grows at around 5% to 6%, orphan drugs are expanding double that to 10%- 12% annually, which is twice the speed of the overall market. This means that companies and investors that are active in the rare disease are positioned at the very center of the most dynamic growth in global healthcare. This extraordinary growth is not accidental. It's built on sites of unique incentives. It begins with speed, reaching the patients sooner because patients can't afford to wait.
Orphan drugs are often moved through development faster, typically reaching the market in about five years compared to a decade or more for common diseases. Once approved, companies are rewarded with long market exclusivity, seven years in the U.S. and 10 in Europe, and protection provides stable, predictable revenue. Third, the FDA has built an entire support system around orphan drugs with dedicated review units and accelerated designations like fast track and priority review and raised fees. Finally, there's a strong legislative backing. Since the early 1980s and the establishment of the Orphan Drug Act, a lot has changed in this market. We can fast forward to today in 2025. New rules in the Big Beautiful Bill in the U.S. have now even exempt orphan drugs from Medicare price negotiations.
Exactly this combination of incentives has drawn big pharma deeply into the orphan space, where more than half of all orphan revenues come from just 10 companies. Typically, Roche leading with fielding oncology, Novartis shaping rare diseases with its gene therapy and strong hematology franchise, and of course, Pfizer, and Johnson & Johnson have invested, making rare diseases part of their core business. For these companies, orphan already represents around 20% of the total sales, which is not a sideline but a major growth driver. The economics tell an important part of the story because orphan drugs serve such small patient groups. They rely on premium pricing, on average about 17 times higher than other medicines. It's not only big pharma that sees the value. This market is also of great interest to investors. In the Nordics already, investors' role has been especially decisive in shaping some success stories.
In my research, I had the opportunity to interview HealthCap, a leading life science investment company. Over the years, they have invested about $120 million, on the upper range of $123 million across eight orphan drug companies, creating some of the Nordics' most valuable rare disease assets. I choose a powerful example of Wilson Therapeutics, a Swedish biotech developing a treatment for Wilson's disease, which is an ultra-rare condition because it's affecting only 10,000- 30,000 patients worldwide. Despite serving such a small population, the therapy addresses a life-threatening unmet medical need. Within just six years, the company was acquired for the staggering $855 million by Alexion, which also shows a life-size scenario of investing in an ultra-rare condition and having a shorter timeline in return.
In one of my conversations with a HealthCap partner, I shared something interesting during the interview, a perspective on the fact that regulatory exclusivity can be an even stronger driver for value, which gives smaller companies freedom to grow without immediate competition. The same dynamics are no longer limited to rare diseases. They are now driving the next chapter of medicine as well, laying the foundation for precision medicine. Because rare diseases affect only very few patients, companies had no choice but to design therapies that are highly targeted, often to a specific genetic mutation. In many ways, orphan drugs were the first true examples of precision medicine in practice. Our first targeted treatments, the technologies that grew out of orphan drug development and gene and cell therapies and antibody drug conjugates, RNA medicines, and all the data accumulated around it are now being applied to larger diseases.
What was once used for rare disorders is now transforming how we treat different conditions. Second is enhanced diagnostics. To find rare patients, the field advanced genomics, biomarker testing, and now using even AI-driven diagnostics. Those same tools are enabling us to identify subgroups in much larger populations and match them with the right therapy. In other words, the orphan framework has proven that targeted high-value treatments are possible and today is becoming the blueprint for precision medicine across the entire healthcare system. With that in mind, let me leave you with three key insights from my research. First, orphan drugs are the fastest-growing segment in pharma currently, and both pharma and investors are benefiting from the predictable value in this space. Thirdly, they are shaping the future of precision medicine. I believe we will be seeing a lot more investments and shifts in this area.
To conclude, my research in close collaboration with Martin Jönsson at AlzeCure Pharma resulted in comprehensive reports from pharma reports. Over the course of this research, I spoke with Swedish investors who have committed millions of dollars to building orphan drug companies and with executives who have successfully brought these medicines to the U.S. market, combined with regulatory and IP perspective. To have a look at the full interview analysis and detailed findings captured in the reports, I would welcome you to scan the code for downloading the full report or later available web link. Thank you for your attention, and I'm looking forward to discussing the Q&A session.
Thank you so much, Dimitrina. A very great presentation. We are now heading into the presentation of Märta Segerdahl. Please bear with us.
Hello, everyone, and thank you for being here with us this afternoon. Thank you, Martin, for your very kind introduction. My name is Märta Segerdahl. I'm an MD PhD, a specialist in pain medicine, and I'm also the Chief Medical Officer of AlzeCure Pharma . We have been talking about erythromelalgia, but exactly what is that? Very few people have heard of it. It's a rare, chronic, painful disorder. It's also called burning feet syndrome. It's a triad of redness, swelling, and intense pain. This pain comes in attacks that are called flares, and they're triggered typically by heat or stress, meaning physical stress like exercise. You can see these photographs below here. These are from actual patients. These are not Photoshopped.
You can see, especially in the middle, this picture of this woman with a picture of her when she's fine between attacks and then when she has an attack. As you can see, it's red, it's swollen, and it also looks like she's in pain. One flare or one attack can last for one hour or it could last for several days. Erythromelalgia is again divided into primary erythromelalgia, which is mostly hereditary and often linked to mutations, but not everywhere, and secondary erythromelalgia, which is usually triggered by severe illness like a malignant disease or an autoimmune disease or even by some medications. How does it appear and how common is it really? The prevalence of erythromelalgia, meaning how many people actually suffer from this at one point in time, looking at the primary and secondary together, is approximately 13,000 per 100,000 individuals. That qualifies as an orphan disease.
When we did our application to the U.S. for an orphan drug designation, the literature helped us to find that there is a number between 43,000 and 70,000 individuals estimated to have erythromelalgia. That well qualifies for the orphan drug threshold of below 200,000 individuals of the U.S. population. It can actually start very early in childhood, from age four to six and up to adolescence, but also even start later in life. Primary erythromelalgia is mostly a lifelong and disabling disease with very many secondary complications like skin wounds, etc. It could also be an inflammatory microvascular disease like in secondary erythromelalgia. That could be a side effect to medication, but also a co-phenomenon where you think that the microvascular disease is the only problem, but no, that's not quite it. It's also erythromelalgia. These individuals suffer from pain attacks. They feel a very intense burning.
It's very clearly characterized by patients. The increased temperature could be ambient, it could be a fireplace, it could be it's warm outside, or it could be very local, like you have the sun shining on you or you have too warm clothes on. The only remedy that actually works today is either cooling your feet in ice water or putting them in front of the AC or a cooling fan. There is a global patient advocacy group for this indication, and they give out surveys every few years. The 2021 survey is now published. From this, we can conclude that the hereditary forms actually start by age, roughly by four to 20. One thing is literature, one thing is a questionnaire. The sporadic forms often occur in adult age. Who do they see? Do they see general practitioners? Not really. They won't really recognize this.
It will take more than a year from a contact for the first time to a diagnosis and not until they've seen a neurologist or a dermatologist or a rheumatologist. Basically, it's a specialty care disease. The pain flares come either most days or pretty much every day. As you can see from the right-hand pie chart, about 75% have most days or every day. They're burning, as mentioned. They have a varying duration between one to five hours or even more than five hours. The typical daily pain, like an average pain, is what we call moderate pain, so between three and seven out of ten on the zero to ten scale, and ten is the worst you can even think of. The worst-case pain when they have their attacks is between eight and ten out of ten.
As a comparison, you could say that a delivery of a baby is about eight out of ten, and an amputation pain could be around the moderate range. This is quite heavy and severe pain. Flares are mostly triggered by heat, physical stress, but also in other conditions. It could be like it's in combination with a flu or some infection coming on. Best therapy still is cooling, which can be damaging. They can actually get wounds from the cold water or cold fan, and then they could get infected and be very scared, get a lot of scars on their feet or hands or whichever area it is that is affected. There is no effective medical treatment. That also fulfills the orphan criteria, not only the number of patients, but also that there is no effective medical treatment, not only not approved, but nothing effective.
It's a lifelong disease, and some patients actually improve over the years, but the mainstay of patients actually get worse. 50% of them actually get worse, and about one-third have about the same level of problems, and a smaller group actually improve. The improving part is usually the patients with the secondary erythromelalgia, where they have realized what the problem is and they have cured the cause for it. As it could be understood, this has a huge socioeconomic impact also for the patients, but also the family and caregivers. What has this to do with the TRPV1 receptor? The TRPV1 receptor is actually key in pain signaling. The receptor, as Martin mentioned, was characterized in the 1990s by the group of Professor David Julius, and it was shown to be central for the mediation of heat and pain.
The receptor is also called the capsaicin receptor, capsaicin as in chili. When you heat the skin, this little figure on the bottom right shows that if you heat the skin, shown at the bottom, very bottom of it, you can actually increase the pain and the circulation, the redness significantly. When you cool it instead, it goes down. The receptor triggers the release of vasodilating substances from the sensory nerve endings as part of everything. It's very similar to the way the capsaicin works. The target mechanism then, the TRPV1 receptor or capsaicin receptor is central to the initiation of the pain signal, also called the transduction. It's distributed all throughout the body. If you have a painful condition like a neuropathic pain, these receptors are upregulated. That means that there are more of them, and they're also more sensitive to activation.
Previously, there's been a number of TRPV1 antagonists, like in the first decade of this millennium, and they have been halted or changed to other topical indications, such as Novartis. That's because these candidates were very effective. They were given orally, and then they challenged the whole systemic target effects by the reduced heat sensitivity all over the body. Patients could actually get unintended burns and scald themselves when they were drinking hot drinks, which of course is not a feasible trait for a new treatment against pain. In many cases, patients also got transient hyperthermia, but this was not the key reason for closing down the projects, as we've become aware from different types of contacts and publications.
By developing a topical formulation that we've done at AlzeCure Pharma , ACD 440 is now a gel, and we have circumvented the problems with the systemic side effects because the effect is only where the gel is applied. This opens up the possibility of adding on to the orphan, but also precision medicine in the subpopulations of chronic pain patients with heat hyperalgesia, where current treatments are known to be ineffective. As mentioned, erythromelalgia is one of these diseases, disorders. What does an orphan drug designation add? We were granted the orphan drug designation for the treatment of erythromelalgia by the FDA. The pre-IND meeting we had with the FDA in Q2 this year, they were very supportive of our development program and encouraged us to pursue this further. There are several benefits with an orphan drug designation.
It's granted for severe and life-threatening diseases without currently available treatment options. In the U.S., the disorder must affect less than 200,000 individuals, and in Europe, the prevalence must affect fewer than five, up to five out of 10,000 individuals. With both agencies, there are several advantages supporting the development of the program. One thing is an agreement on program design and output with both agencies and all the way up to market application for both agencies. They're very open to some flexibility, but they have exactly the same requirement for the drug to be efficacious when it comes to launching it and going to market. This also opens up to more frequent interactions along the way. It actually encourages to do so, but it also reduces the risk of a failure in phase III.
That's shown as Dimitrina Dimitrova demonstrated that there are much higher approval rates when you have your phase III data. Why do we think that ACD 440 gel blocks the TRPV1 receptor in reducing this heat-induced pain? We have conducted two studies, one in healthy subjects where we exposed them to experimental pain, and we reduced the heat-induced pain by 50% compared to placebo after only one hour of application. The pain reduction actually lasted for almost 11 hours after only one hour of application time. That publication is free and possible to download, open access. We conducted a study in patients with chronic neuropathic pain with sensory hypersensitivity. That means that they were actually sensitive to high stimuli that triggered the pain further. There we reduced the heat-induced pain by approximately 50% as well. That publication is also available as open access.
Just a note that 30% reduction in pain intensity is considered a clinically relevant reduction in chronic pain intensity by regulatory guidelines worldwide. Are there only help in developing? Not only because this has other following effects. In general, the smaller programs have lower risk and shorter time to market. There is a reduced cost for clinical trials, not only because they're smaller, but also because you have tax benefits for the clinical trials. There is no fee for marketing submission for a small company, a reduced fee for big pharma, which is also a cost that is substantial. They are also exempt from Medicaid price negotiations, as mentioned by Dimitrina. You have an orphan drug market exclusivity for seven years. If you co-submit pediatric data, you have another six months of market exclusivity.
EMA has a similar program with free and frequent scientific advice and no fees for marketing submissions and no fees for the actually quite expensive activity of agency inspections during the review of the submission packet. In the EU, orphan drugs get 10 years of market exclusivity for each orphan designation indication and an additional two years for pediatric indications. There is slightly longer, considerably longer exclusivity in the EMA area. Now what we'll be doing here after having this orphan drug designation granted, we will continue the preparations for a full development program in erythromelalgia. During that, we're focusing on optimizing the program design in all aspects. We're aiming for the shortest time to market and to patients. We will be pursuing, of course, business development activities, looking for the best partner to take this asset to commercialization.
In summary, erythromelalgia is a rare and chronic disease of all ages. The pain in erythromelalgia is triggered by heat, and ACD 440 is effective in reducing heat-induced pain. It's a good match. The granted orphan designation shows that the FDA supports the rationale for the development of the TRPV1 antagonist ACD 440, especially in erythromelalgia. The designation also reduces developmental costs and gives us substantial market exclusivity going forward. Thank you so much for your attention, and I will hand back to Martin.
Thank you so much, Märta, for a splendid presentation. What we will be doing now is to go into a Q&A session. You, as listeners, are very welcome to send us questions, and we are looking forward to answering them. The parties involved in the Q&A are, of course, today's presenters. With this, I'll hand over to our moderator at Finwire. Please, Martin.
Thank you very much, Martin, and everyone, for that presentation. Yes, let's open up the Q&A session here. We'll start with the first question. What are the main challenges and also opportunities in positioning ACD 440 as a first-in-class treatment for erythromelalgia?
Märta, do you want to start?
I can start with saying that it would be a first-in-class because there are no approved treatments. I think that's a very simple answer to the question. You probably have something to add on to that, Martin.
Yeah, the opportunity is, of course, that we will be able to help patients that are in need. As well as to go into the, as an orphan, is also based on a commercial opportunity, very, very attractive. As an orphan designation in the U.S., we will then expect to have at least seven years of market exclusivity. In the EU, 10 plus two. We are, of course, also looking at the opportunity in the rest of the world. Additionally, we should say we are not only looking at erythromelalgia, there are also other orphan indications which are possible. For each additional orphan indication, you in the U.S., for instance, get an additional seven years. This is very attractive. Thank you.
Thank you for that answer. We'll take the next question here. Is there still interest to continue with ACD 440 in peripheral neuropathic pain?
I can start. First of all, I can say that the initial study we have done in peripheral neuropathic pain was very promising. The reason we are now going for an orphan is that we see this as the fastest possible way to the market. We also see it as the most cost-effective way to the market. We, of course, still see that there is a huge unmet medical need and a very attractive opportunity also in peripheral neuropathic pain. Initially, we will focus on erythromelalgia.
Should I add something?
Yes, please.
Yes. I would say that in other indications where there is a trigger of the pain due to heat, this would be an additional precision medicine tool that adds to the rest of the library of pain treatments. Today, it's quite well understood that neuropathic pain is rarely treated solely by one medication. You need a combination, and this would actually be the treatment specifically for this heat hyperalgesia, which affects quite a number of patients with different types of peripheral neuropathic pain.
Yeah. What Märta said here is so important because in the phase II study we did in chronic patients with peripheral neuropathic pain, we allowed the individuals to stay on their oral medication. Even if they were on those medications, you have gabapentin, you have opioids, etc., our assets, ACD 440, added an additional 50% in pain reduction. That shows the opportunities. This will then add additionally. That it can be combined with other pain medications is very attractive.
Thank you for that answer. What will AlzeCure Pharma 's next step be with the EM project?
As I presented to you, we will look in because we have very good feedback from the FDA. They're very supportive. We still need to look at the full program and to optimize every piece of it to be as swift and as smooth of a run for whoever takes it to the market. I think that's actually our next step to work on the plans for this.
To work on the plans and then also to work together with CROs to map out the full program and also the costs, we have already done some work around that. When we were in contact with the FDA, we got some additional questions. We will work on those details as well. We have full focus now on really developing the development program, and in connection with this, also continue, as Märta said before, pursuing the BD dialogues that we already have.
What is your BD strategy for the project?
Our BD strategy is to out-license this project. We are a biotech company. We are specializing in discovery and early development. We do not have an intention to develop a commercial organization. This is about out-licensing this project to the specialists who already have, how should I say, a relationship with the physicians who are treating these disorders. If we look at that today, it is the pain specialist, it's the dermatologists, and Märta, who else is it?
The neurologist.
The Neurologist, of course.
To some extent, rheumatologists, and it's a secondary hyperalgesia. Also, actually, pediatricians.
Yep.
Thank you both for that answer. How big is the erythromelalgia market in terms of value?
There is a report on erythromelalgia, and that report is stating that the current market is worth about $2.6 billion. What's interesting there is that today there are no approved pain medications for erythromelalgia, as we talked about. To be able to come in, and also that the current drugs aren't effective, to be able to come in with an effective, safe drug in this market would open up very attractive commercial opportunities.
Which other development projects exist within the EM landscape?
I wish I could give you a positive answer to that one because there's been a number of efforts. As far as we could understand from literature and from the site clinicaltrials.gov, there's no ongoing projects. Also, there have been no positive trials registered on clinicaltrials.gov, and there's nothing ongoing at present. It looks like it's going to be a challenging comparison because we can't see that there's anything really in the development pipeline for erythromelalgia.
Thank you, Märta, for that answer. Are there any additional orphan indications for ACD 440, which could be of interest for ACD 440?
There is a number of either subgroups or larger patient groups, like diabetic polyneuropathy, for instance, where some of the patients actually have a burning pain, which is not reduced by the standard treatments. There are also many other small indications where we are looking at the possibility and the scientific rationale for looking into those as well.
When would it be feasible to have an approved drug on the market?
I would say that depends on the outcome of our fine-tuning of the development program. It's difficult to say exactly a year or anything like that or a time span because everything has to fit like pieces of a jigsaw. We can come back to that when we have a full picture from both regulatory agencies and our fine-tuning of the program. I think that is a good time to come back to you and respond to that question.
Thank you, Märta. Up until now, you have been focusing on the U.S. market. What is your strategy and intentions for the rest of the world and the remaining markets?
The reason why we have been initially focusing on the U.S. market is, like Dimitrina stated before, about 60% of the orphan market is in the U.S. Therefore, we are beginning with the dialogue there. We are now also pursuing the EU, and of course, we also see Japan. Totally, we see this as a global opportunity. This is a global asset, if we say like that.
Thank you. How do you view the future of the orphan drug market? Is it still growing?
Dimitrina, that is something for you.
Yes, a short answer. It is the fastest growing segment in pharma. As I've shown in some of the figures, it's really expanding. The commercial value is larger, but that's also because of the set of unique factors in the orphan drug space. Over 90%, 95% of rare diseases don't have any existing treatments. In that way, there's a lot of patient advocacy, but also it's attractive commercially. As those treatments are looking to be around $200,000 per patient, $1,000 per patient. There's many angles to it, and looking at that combination of factors is providing a lot of competition among companies to put the first-in-line treatment, be approved, and receive an orphan drug designation. There's actually just the beginning, if you can say it that way.
I think also to add to that, as Dimitrina Dimitrova presented earlier, with improved diagnostics and using genetics, etc., we will understand diseases and patients in a much, much better way. Based on all the input we have from the patient, the disease development, etc., we will see more and more precision medicine. The smaller segments of indication will only grow, and it will grow rapidly, truly.
Märta, any thoughts around that as well?
I couldn't agree more, I should say. I mean, we're learning so much more from biomarkers, from diagnostics, as you say. We now, for instance, in the Alzheimer's space, have APOE4 specific. We have other types of Alzheimer's disease that do not respond to the new antibodies or should not take them. It's pretty much the same in the pain space with all the different pain indications, basically, based on the new classifications and the different neuropathic pain states. I think the field of precision medicine is actually growing. These are, of course, smaller indications. Some of them are orphan, most of them are orphan, but I will still put them under the umbrella of precision medicine.
Thank you for that answer. Do you see ACD 440 as a lifelong treatment for patients with erythromelalgia? As a follow-up, do you see any risk that patients could become desensitized to ACD 440?
Those are two very good questions. The first question is, yes, it's a lifelong disease. There's no reason for us to believe that there is either reduced effect or tolerance development, as we call it, as you can see with other types of drugs. We don't have any indications that we would actually be reducing or taking away the disease per se. I would say it's a lifelong disease, and it would be a lifelong treatment. Do we see a desensitization? No, I wouldn't say so. I mean, as you say, there is a capsaicin receptor blocker or antagonist, this ACD 440. There is an 8% capsaicin patch that has the indication of neuropathic pain, but it doesn't really affect or it doesn't really truly act only on the TRPV1 receptor. It actually affects the whole sensory nervous system in the skin.
The effect is actually much more, much, I say, robust or crude. It's a TRPV1 receptor antagonist. I don't think there would be any desensitization. That's also nothing that we have seen in the studies that we have conducted.
Thank you very much for that answer. That concludes the Q&A session. I'll hand over the word to you, Martin, for some concluding remarks.
Thank you so much. Final remarks on today's sessions on orphan drugs and ACD 440 and erythromelalgia. What we can say around this opportunity is that the orphan drug market grows rapidly, twice as fast as for common drugs, and also with prices which in general are 17 times higher than for common drugs, which really shows how attractive the orphan drug market is. It is also highly attractive both for big pharma and institutional investors, which is important, of course, both when it comes to acquiring these projects as investing in AlzeCure. This asset, ACD 440, for erythromelalgia, represents a major opportunity for us as a company, moving the company up towards a potential registration trial, and this creating the opportunity to have a shorter time to the market. Within orphan, we know it's much smaller studies than with common drugs.
Additionally, we know that the unmet medical need in erythromelalgia is major, and there are currently no approved drugs with this indication, and there are no other drugs available which are effective in erythromelalgia. We are very happy that we have received positive feedback from the FDA on this potential registration trial with ACD 440 in erythromelalgia. Our main strategy is now to out-license ACD 440, which we are working on, while preparing for a potential registration study. Those are the take-home messages, and we look forward to uploading this presentation at our site for AlzeCure. We are also looking forward to make Dimitrina's report available. Please scan the QR code, which Dimitrina had in her presentation. With that, I would like to thank both Märta and Dimitrina for an excellent presentation. I would like to thank you for attending this seminar and wish you a great day.
All the best. Take care.