Thank you, Robert. It's my favorite conference. I love fireside chats, and it's a great time because we have a lot of events coming up in 2025.
Excellent. Very good. Well, let's sort of jump into it. As you know, whenever I have you on, I'm always sort of amazed by just sort of the number of moving parts to Jaguar. You know, you have FDA-approved products that were sort of internally developed. You've got FDA-approved products that have been acquired, right? Development-stage products through various subsidiaries. Beyond that, you're really sort of this pipeline within a product with multiple follow-on indications, and I think we'll get into all of that, but let's sort of start with the commercialized products first. You know, talk about crofelemer, why it's so unique, and the markets that you're looking to address.
Yeah, thank you so much. You're right. We do have a lot going on. I call us a little big company because we have everything, and even more because our commercialized product comes from the rainforest. So we do everything from manufacturing through commercialization, all the steps in between, and we sustainably supply from the rainforest. And that's what you're referring to there, crofelemer. And that is our lead asset. It's not our only asset, but it's our lead asset. And it's the product that we commercialize now for chronic situations and people living with HIV/AIDS. But we are on the cusp of putting together our regulatory filing to potentially expand the indication to cancer therapy-related diarrhea based on results from a phase III trial that we completed last year called the OnTarget trial with positive results in breast cancer patients. So it was a huge study.
We brought in all solid tumor patients, but where we saw the response was in a responder analysis in the prospectively defined group of breast cancer patients on targeted therapies, those therapies that patients are on for the rest of their lives in a metastatic situation and even for nine, 12, 15, several years in a curative situation. That commercial lead with crofelemer has brought us into the whole area of cancer supportive care. And that's where we are now looking to acquire products as well. Crofelemer, any product that you develop, takes many years to develop. There's 21 unmet medical needs in supportive care in the cancer area. And so last year, we did acquire Gelclair for oral mucositis, and we are looking to bring in other products and make a major development and commercial push into cancer supportive care.
Then the last comment to respond specifically to your question is, that is the next indication for crofelemer, but we also have programs going on in rare diseases and other GI diseases because of the novel paradigm-shifting mechanism of crofelemer that allows us to go after other unmet needs in other patient populations as well.
The current commercialized lead indication is for HIV-related diarrhea in human use. And then you also have sort of Canalevia. Talk about both of those.
Right, crofelemer is commercialized, as you mentioned, in two areas. HIV for humans and Canalevia, interesting, is chemotherapy-induced diarrhea, a conditional approval in dogs. A conditional approval is when it's a limited number of patients, but there's nothing else out there. You can get the product on the market while you're finishing the clinical trial, sort of a little bit equivalent to orphan drug designation on the human area. And so each of those products are growing. Their prescriptions are growing, which is terrific. On the human side, what we're seeing in HIV is that the side effects of the therapies from HIV, in particular the GI side effects, are much less than they used to be, by the way, in contrast to cancer, where they're growing and getting worse every single day.
But what's happening in HIV is the enteropathy, the inflammation in the gut, particularly as the HIV patient population is aging. You have more than 50% of the patients living with HIV have been diagnosed over 10 years. And there are acceleration of aging diseases, cancers, diabetes, arthritis, and GI issues. And the one that you can see, the first symptom that you can see often is the diarrhea. So that's the growing market opportunity in HIV. The other interesting thing is some changes that are occurring in Medicare Part D, and there is a limit on the out-of-pocket spend for Medicare patients in the first quarter as opposed to last year and the years before that. So that may assist in the continued prescription growth that we're seeing as we go into the first quarter of 2025.
On the doggy side, what's interesting there is that if you are a patient in the United States with cancer and diarrhea and you're a dog, you can get a prescription for crofelemer. And the human, not yet, but we're working on that. And the dog is a remarkably predictive situation and model of the human situation. That's not why we went into that market. There's a dramatic need for dogs. But if you just looked at the gut and the channels that crofelemer normalizes, you wouldn't be able to distinguish whether it was a human gut or a dog gut. Dogs get targeted therapies. They often get human therapies. They have the rate that is the same as humans.
About 40% of the time, the patient, whether it's a dog or human, goes off their targeted therapy, goes off their cancer therapy specifically because of the side effect of diarrhea. So the success that we're seeing there and the growth in the market and the support from the cancer therapy manufacturers who point to crofelemer because it allows the patient to stay on their lifesaving therapy is hopefully predictive and relevant to what we're going to see in the human market.
Right. Great. You know, sticking on sort of the commercialized products first before we dive a little bit more into some of the future indications here, you signed a license agreement for Gelclair for the U.S. market, as you mentioned, and initiated really the commercial launch just in October, right? So sort of the fourth calendar quarter of this last year. This is now your third prescription product, right? How does this sort of in-license and commercial launch of this FDA-approved and again, oral mucositis prescription product support sort of the overall plans that you talked about for cancer supportive care?
Great. Thanks for asking that. The mucositis is the most noxious side effect associated with cancer therapy. So it's the wounds that occur in your mouth. It feels like broken glass in your mouth. Patients can't talk. They can't even fully open their mouth. They can't drink. They can't eat. Many times they end up in the hospital to get parenteral nutrition. So it's a very important indication to focus on for both patient comfort, quality of life, but also the ability to keep them on their therapy. So we had this opportunity to in-license this product. This would be our first commercial footprint into cancer supportive care because we don't have crofelemer, Mytesi approved yet at this point for cancer. So we had to think about, you know, small company, how do we do a first commercial footprint?
You know, how do you get into it on a stepwise basis? So what's interesting about mucositis with the new ADCs and targeted therapies, it's about 60%-70% of cancer treatment overall. But in head and neck radiation, HPV patients and bone marrow transfer patients, it's essentially 100%. When they get to a certain level of radiation, they are in the head and neck radiation patients, they are going to get oral mucositis. And so with a very small focus salesforce, we could immediately put our first step into commercialization, get our reimbursement strategy, our distribution strategy, our messaging, our education, our promotion, get it refined. And then hopefully in a year or so with success with Mytesi for cancer therapy-related diarrhea, we would be able to expand that salesforce to go to the entire oncology market and at that point have two products in the bag.
Excellent. Talk about maybe some of the scrip trends, some key catalysts for, again, the existing indications and for now the launch of Gelclair here coming up here in 2025.
Yeah. So as I mentioned, Medicare Part D, so again, reducing the donut hole, the amount of that patients are responsible for in the first quarter, that we suspect is going to be a boost for the first quarter of 2024 versus 2025 versus 2024. Expanding coverage for Gelclair into the Medicare arena will be very important. And continued, as we all have to do in this U.S. healthcare system, continuing the education and the support that we can provide for prior authorizations because just about every product and certainly every new product that's coming on the market requires a prior authorization. So we have some methodology and support and patient programs on the HIV side. And HIV with Mytesi is a chronic treatment, whereas Gelclair often will be for 30, 60, or 90 days.
So luckily, we gained that experience on the HIV side and are able to bring those patient support activities into the Gelclair arena and get those prescriptions not only written, and there is great enthusiasm from the healthcare community, but to get them filled and reimbursed in a timely manner.
Right. All right. Let's sort of transition right to the pipeline, and you've talked about, we've talked about this sort of a product with multiple follow-on indications, really sort of a pipeline within a product with crofelemer here. Let's start with sort of cancer therapy-related diarrhea, CTD. December 11th, I think it was, right at the San Antonio Breast Cancer Symposium, you know, the company presented statistically significant positive results from the pre-specified subgroup of adult patients with breast cancer from sort of the recent phase III OnTarget trial that you mentioned a moment ago. Talk a little bit about this study and these results, what sort of the plans are looking forward and development for now this really unique new area for you to branch out into.
Yeah, it is such an important study. This was called the OnTarget study. And as I said, it was a big hug to the cancer community. The enrollment was all solid tumors, patients on targeted therapy. It was prophylaxis, and it was patients with or without cytotoxic chemotherapy. And part of the opportunity, the value opportunity in Jaguar right now is we did not achieve the primary endpoint, and we took a big hit for that, and that was announced last year. But as you mentioned, what we did achieve in the prospectively defined subgroup of breast cancer patients, which were close to 70% of the patients in the trial, statistical significance in the responder analysis. And the responder analysis is the analysis that is consistent for the novel mechanism of action of crofelemer throughout its years of development and dozens of clinical trials.
It's the analysis for the current approved indication for HIV. It's an analysis in two IBS studies that we presented at AGA last October, and it's analysis that we will take forward to a briefing package and expected meeting with the FDA in this quarter to support a filing to extend the indication of Mytesi, the current formulation of the approved product potentially to breast cancer patients as a supplemental NDA, and that's an interesting point as well. The two most common reasons why new drug applications fail are safety and manufacturing. We don't have those issues with Mytesi. Mytesi is already approved for a chronic indication. We have chronic safety. We have a full supply chain in place.
So it's putting forward these results in the breast cancer patient population, briefing package, discussion with the FDA, filing a supplemental NDA, and then hopefully with success, bringing Mytesi to those patients in need in cancer around the end of this year, the beginning of 2026.
Okay. Beyond sort of the breast cancer here, last month, you initiated a phase II study to evaluate crofelemer for MVID. Sort of talk about this sort of congenital diarrheal disorder, this ultra-rare, sort of development plans and some of the benefits of sort of an orphan drug rare disease business model.
This is so exciting. So as you know, there's many companies that their entire strategy is orphan rare diseases. This is a component of what we do. This is crofelemer, but it's not Mytesi. It's not the approved formulation. So Mytesi is a little pill. I should have a picture of it. And this is a highly concentrated liquid formulation. So it's a different product of an approved active ingredient. And the indications that we are pursuing are MVID, microvillus inclusion disease, and short bowel syndrome with intestinal failure. So what is that? Okay. So these are situations, short bowel syndrome, where there's not enough surface area for patients to absorb the nutrients of life. And they often end up on parenteral nutrition for 20 hours a day, seven days a week. So no quality of life. It's a catastrophic healthcare situation. There's all sorts of complications, and it's expensive.
Costs about $500,000 a year to keep a patient on parenteral nutrition without complications, and you can imagine the complications, infections in keeping the balance of the fat and the proteins of the parenteral nutrition, so it often ends up on average to cost about $1,000,000 a year to take care of these patients. SBS is an orphan indication. We have orphan designations. It's about 40,000 patients around the world. That's intestinal failure when you're on parenteral nutrition. MVID is a congenital diarrheal disease, so children are born with this. This is an ultra rare disease, so it's about probably 200 to 300 patients around the world, and they have the same situation. They have intestinal failure, so they're on parenteral nutrition from the day that they're born, if they're diagnosed. If they're not diagnosed, they die. They're diagnosed every single day of their life.
Often these kids don't live beyond being 12 or 13 years old. In this situation, their intestine is fully intact. It's not functioning. In particular, microvillus inclusion disease, the little villi that are sticking out that are in your gut that are reabsorbing, you're constantly secreting and absorbing, secreting and absorbing, they're inverted. They're not absorbing anything. There's massive cholera levels of diarrhea from the moment the child is born. It's the pure clinical manifestation of the novel mechanism that crofelemer as an anti-secretory can normalize and can benefit. We have two patient populations that can benefit from the same mechanism of action, the same formulation that are both having intestinal failure, that are both on chronic parenteral nutrition, but with different physical manifestations, one the short bowel syndrome and one the MVID.
What's interesting about that, we are going forward with both of these patient populations right now. We have two phase II clinical trials and three investigator-initiated trials, all that are catalysts from December and the first quarter of 2025. There's no alternative for MVID. In SBS, there are some patients, not standard of care, that can benefit from a growth hormone approach to try to grow the intestine a little bit to give them a little bit more time to absorb the nutrients of life. In MVID, the gut's fully intact. So there's no option out there. It's an opportunity, therefore, because of the orphan designation and because of the ultra rare nature of this patient population, to get approval and opportunity for patients to have this product with potentially a single digit number of patients.
We already have 12 patients identified around the world who will be treated, and according to our plans, who will be treated with crofelemer in 2025. It's very exciting what we can do for these patients. It's very exciting how it can get the product into utilization even before complete approval for short bowel syndrome.
Yeah. One of the things I was sort of looking into here was the pediatric gastroenterologist serving as the investigator, right, for this investigator-initiated trial in Abu Dhabi, right, for MVID and SBS is on your scientific advisory board. Maybe for those not familiar, talk a little bit about him and his role here.
Yeah. His name is Dr. Mohamad Miqdady. I've known him for about eight years right now. He heads the Pediatric Gastroenterology Society of the MENA region. And he has a conference that he hosts every year in May that we have sponsored and we've spoken at several times. So he, as you mentioned, is doing the investigator-initiated trial both for MVID and for pediatric SBS patients. And our trials are all being done on a global basis, U.S., Europe, and the Mideast, particularly the UAE, Abu Dhabi, and Dubai. And so why did we include that area? Because it's the right thing to do. And because of the genetic nature of these diseases and the consanguineous marriages in that culture, there is a much larger identified population, particularly of children with these congenital disorders, and there's sort of a watch for them.
So sometimes children who have a genetic disorder like MVID or any other congenital diarrheal disorder are not identified right away, and they are sort of a weak child, and they end up dying. So it's a very powerful collaboration and patient population that we're able to access through Dr. Miqdady. For example, he has probably five dozen patients that he's following, pediatric patients with congenital diarrheal disorders. In the United States, a pediatric gastroenterologist might see a patient, one patient in their entire career. So the knowledge base, the benefit that we can show, and the access to patients to get the data that we need, the proof of concept data to get into these early access programs to get crofelemer into patients and reimburse is accelerated through our relationship in Abu Dhabi.
Maybe spend just a minute talking about, we'll call it the competitive landscape maybe, and maybe get in specifically within sort of adults with SBS there. And I know there was the FDA issued, I think it was back in December to Zealand Pharma, a letter there. So maybe just talk about that, talk about the competitive landscape and really what the significance was of that FDA decision provided to them.
Yeah. So what you're talking about is this is short bowel syndrome and a growth hormone approach. So there is a product that is approved. It's called Gattex in the United States, teduglutide. And it is essentially a growth hormone for short bowel syndrome. And what it attempts to do is, I think I mentioned earlier, grow the gut a bit so that there's a bit more opportunity to absorb and reduce parenteral nutrition by about 15%-20%. And it is approved, but it's not standard of care. It's used in a single-digit percentage of patients. So part of the issues with the growth hormone approach is can't be used in cancer patients or patients who have a risk of abnormal hyperproliferation. You certainly don't want to have proliferation of cancer cells with a growth hormone.
It can't be used until about 12 to 18 months after surgery because of bowel adaptation, and about a third of short bowel syndrome patients are due to some sort of surgical intervention. And then there is some cardiovascular risk, some endocrine risk. So there's a lot of limitations in how it can be utilized. Zealand's product was a biosimilar. And we don't exactly know why it didn't get approved, but everything that's in the pipeline for short bowel syndrome other than crofelemer is a growth hormone approach. So it has to be teduglutide has to be injected. So can it be a little less irritation, different half-life, biosimilars? So they're all going to have the same safety limitations.
Crofelemer is the only approach in this market that is looking to become standard of care, can be used with or without a growth hormone approach, has the long-term safety record that it already has, and get to the same regulatory endpoint. And that's what the growth hormone approach has done. It has established a regulatory endpoint. So that's exactly what we're looking to do by decreasing the secretions a bit, give the patient the opportunity to reduce their dependence on parenteral nutrition 15%-20%. Also, let's have a little bit of stool formation. We are an anti-diarrheal. And then also, as always, focusing on the patient need, the quality of life. And in MVID and our pediatric studies, we're also looking at the quality of life of the entire family and the healthcare team.
Because once you get a diagnosis of MVID in your child, your life has changed. The whole family has changed for the rest of your life.
I can imagine. Few minutes left here. Let's transition quickly to Magdalena. Talk about this sort of set up the relationship there and the opportunity.
Magdalena is going back to our roots, pun intended there. So we have 2,300 plants that we have collected over 30 years now with firsthand field investigation. 20% of them have indications in the field the way they're being used traditionally in the mental health area. And that's such an area in need of innovation. And in particular now, of course, there is an interest on psychoactives, psychedelics, natural products. And the joint venture that we have with Filament Health, which is called Magdalena, has allowed us to mobilize that asset that we have. So it was formed a little over a year ago. It costs us nothing because it's funded with outside venture capital money. We own 40% of Magdalena. The last round had a $5 million valuation. So we.