Nothing to say, yet
Transcription
I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. I don't know if you can hear me, but I'm going to try to keep it as quiet as possible. Mind me, please, because it took us just a little while to learn. Okay. Yes, when the red light is still there. Sean. Sean. All right. Good morning, everyone. Good morning. All right. So, welcome. I'm really excited, because here for Rigel Pharmaceuticals, some of the data that we're going to be presenting to you today, it's actually the newest data in a while that we've had for Tavalee. So, myself, Sean, and Aaron are excited to share this and seek feedback from you all and have a strategic discussion on the execution for us in 24 to potentially, if this data is compelling enough, to potentially pull through at a community oncology level. We've been, myself, Sean, and Aaron have been fortunate enough, we've been at Rigel since 2018. Sean and I are on the brand team, and Aaron, of course, is in medical affairs. And we've seen a lot of evolution occur. Back in 18, Tavalee, we launched it, and it was a slow ramp up for the drug initially, but then what we saw was patient identification was occurring, providers were gaining experience, and then, of course, COVID happened. And we know this is a very promotionally sensitive product. During COVID, our sales, quite frankly, dropped, but now we're, again, on that similar trajectory. And, in fact, over the course of 2023, we saw a lot more patient identification occurring, and the drug actually had its best year ever. So, we're back almost on that launch mode of the way we were looking at over the years once we first launched the product. We were thinking about different angles of how we could seek insights from you all, especially in this post-COVID environment, and during this time, Sean had the opportunity, and he'll go more into this real-world project from community oncology where we got this data set. So, as we were planning this ad work towards the end of last year, we thought about it and said that it would be great to have providers like yourselves from the community here to have a discussion on Tavalee, and then, more importantly, but it's not just Tavalee, but how you go about in this post-COVID environment of sequencing of therapies after steroids and the management of ITP patients. And we'll kind of go through the day here. We're going to be done no later than 1130, I promise you. Likely, it'll be a little bit earlier, and there's a break sprinkled in. But, as we go through the day, we'll go through our clinical data. We'll do a little activity to get a baseline before Sean and Erin will come up to present the new data, and we'll do another activity after that to kind of grade ourselves and see how compelling the messages are that we'll be having a discussion of. And then, finally, at the very end, Sean's also going to talk about the market access updates that we have. We have a very, I'll call it aggressive. It may not be the right word, but we have a very good contract for community oncology as well. So, just seeking advice with you from, based on the current data, the new data, and how you feel we could potentially partner with the practices and get the word out and amplify this message out there. So, really, overall objectives is Dr. Keppel is going to come up and just quickly give you the baseline data that most are already familiar with Havalese. Then we'll get into the new data and just discuss factors and triggers of sequencing the therapies as we're having the discussion. Just some housekeeping notes, as all these AdWords are, please, candid feedback is encouraged. The mic is pushed to talk, and why we're recording is just for note-taking purposes. We delete it immediately after taking the notes. And restrooms are out the door, past the glass door, in the hallway to the left. You're expected to attend the session in its entirety. And within the packet, there's an evaluation form. Towards the end, if you could take two minutes just to evaluate us and grade us, help us improve for the future meetings. What I'd like to actually do is just go around the horn and have folks introduce themselves. So, three questions. One, introduce yourself. Tell us a little bit about your practice. Two, now, from the pharmacy side, how familiar are you with Havalese utilization aspect? Three is a little bit more of currently. Do you have either your personal algorithm, or does your practice have an algorithm in the post-steroids setting for managing chronic ITP? So, if it's, okay, within our system, it's steroids, then it's Rituxan, then it's Atipo, and then Tavale, whatever that might be. So, maybe, Kyle, you can kick this off. Yeah, there we go. Is that working? That's working. Kyle Kitchen, Director of Pharmacy and Clinical Services at Utah Cancer Specialists. We're a practice of about 20 medical oncologists, and we're bringing on some rad-oncs as well. And we have 12 sites. So, my familiarity with Tavalese, I manage our formulary and kind of our usage, as well as I manage our daily, or our oral dispensing program. And so, you know, have a fair amount of exposure to at least the business side, as well as some of the clinical side of just managing these treatments. As far as like a formal sequencing, we don't really have that. That's left more in the hands of physicians, but I will say we do some preferencing in different categories. And so, this is one that we've looked at and had some discussion on. But typically, you know, after all that, it is typically steroid, TPORA, and then Tavalese at some point, whether that's, you know, third line, somewhere in there, typically. And is there a TPORA that's of preference from a pharmacy standpoint in the system? It goes back and forth. It goes back and forth. Yeah. More oral, or? Yeah, it has been, just because Enplate had some problems with reimbursement. But that seems to be cleared up this quarter. Okay. So, now it's a little bit softer. All right. Perfect. Thank you. Dr. Travis. So, I'm Pat Travis from Arkansas Highlands Oncology Group, Northwest Arkansas. We've got a large oncology practice with 14 med-oncs. We've got rad-onc, surgical-onc, GYN, GI, and so on. We don't have any pathway structure on any of our drugs. So, it's pretty much med-onc dependent choices that push this forward. I think most of us start with steroids, but there's still a lot of IVIG and rituxan as a second line. Okay. And then after that, just TPORAs? Yes. Okay. Thank you. And do you have any experience with Tavalese, Dr. Travis? I do. Okay. Perfect. Ashwin. Good morning. Ashwin Vasudevamurthy. I'm from Indianapolis, part of the Hematology Oncology of Indiana practice. We're a group of seven medical oncologists, six nurse practitioners, span five to six different sites within central Indiana. We are part of the American Oncology Network partners. Our pharmacy is centralized through them in Florida with kind of various other specialty pharmacies that they work with. We don't really have an algorithm either in terms of it's very physician dependent, so there's no pathway. Sure has, if that's what you're asking. I think we are a very collaborative group and especially we tend to get a lot of ITP referrals as a group in total, so I think we all work on the strategy for patients together if they're a challenging situation. I would probably think that it's probably split between second and third line. You know, after steroids on T-PoRAs versus Tavolese. But I do think our practice has built quite the experience with Tavolese at this point. And I've had experience with it over the last year or so. And at your practice, is Rituxan back in favor of post-COVID? Not that I'm aware of. I think if we have used it, it has been because of urgency or availability in the hospital perhaps. Rick. All right. Hello, everybody. I'm Rick McDonough with Florida Cancer Specialists, 200 plus docs in Florida. There's, as the theme has been really physician dependent as far as the order of events. Obviously, Sanjeev knows I've been using it since its launch. So I definitely talk about it with every second line patient and anywhere beyond just depending upon where they are in their journey and how many people they've seen before they end up with me. So that's kind of where that stands. Thank you. Raji. Hey, everybody. Raji. I work at Orlando Health. We're pretty big. We have about 28 med-oncs. We have gyne-onc, surgical oncology. We're hiring a couple more. It's hard to keep a number in my mind. But I've been working with them since October. Prior, I've been in private practice. So I have familiarity with the drug. I've used other agents as well. At Orlando Health, it's kind of our choice position. So we have no restriction. Whatever we prefer for the patient is what we do. And from what I've seen in practice, typically TPORA, second line, that's what I see a lot of the providers do. Rituximab, depending on the provider. Everybody's different. That's what makes ITP so unique, right? So I see it. I see it coming back. Okay. Great. And, yes, that's it. Perfect. Thank you. Nikon. Yeah. Nikon Ajayi, Chief Operating Officer, Highlands Oncology Group. So I work with Dr. Travis. And basically, my role is far more involved. I work with our director of pharmacy with looking at contract injuries as well as part of a group and a team. And, yes, one of the things that definitely is more exciting to me is going more into the real-world evidence base and being able to evaluate our clinical data and seeing some of those trends. I think we've had some experience with that both in the breast cancer space and also in CLL2 as well, about to evaluate multiple myeloma. So I think that presents a really unique opportunity to look at your own data as a practice and to be able to say, okay, where do we have some opportunities? Great. Thank you. Aaron. My name is Aaron Pepper. I'm a local here in Northwest Georgia Oncology Center. We are about 30-plus physicians now affiliated with WellSTAR. So we have about, I think there's about 10 hospitals in the local area plus. WellSTAR actually now owns the Medical College of Georgia. So it's a bit humongous. But as far as the treatment protocol, I was just checking our protocol. Everything is listed there. So it's a shared patient-physician choice. I, fortunately, have learned about foster maternity capillaries a while back along with Rick. So I can claim that I have been with RIGEL for as long as you guys have been. Almost, right? Right on the mark. So I think I let patients decide. I try to explain the best way I can. And I have used the second line and third line depending on patient preference and counseling from me. So as far as retaxation goes, I think the fear is a little bit gone now maybe as far as not using it. So if somebody's adamant about having a limited option or a limited treatment, I think that's something that we are considering now. Thank you. Thank you. Sean. Say hello. Yes. Go ahead and introduce yourself. Am I backed up? Yeah. I turned it on? Yeah. Okay. Perfect. Sean, as Sanjeev said, I've been with RIGEL since 2018, came on as we commercialized the company, and have been fortunate to work with Tavalese since its launch through May. And it's been working closely with the medical team on the real-world evidence project that was kicked off back in 2021 when we closed the data and pushed it through 2022 to get the paper published and then to figure out how to actually get it into print took another six to nine months. So we're excited to be able to chat about that today and learn a little bit more both from the clinician side of things as well as pharmacy and its implications and how real-world data can translate into practice in such a rare disease as we all know. ITP is not something that is adjunctive. It's not what really drives a practice. But everyone sees it. Everyone knows how to treat it. Everyone treats it individually. So we're excited to see how, at a system level, we can help place Tavalese in a second-line dish and look forward to your feedback. Thanks, Sean. Yeah, good morning, everyone. Aaron Sheppard. I'm part of the medical affairs leadership team over at RIGEL. I've been at RIGEL. I probably joined shortly after you. No, no, yeah. I've been with the show, and I've been at RIGEL. Right around the time that Tavalese became commercially available and continued to work on its efforts as well as supporting other products that we have for AML and future pipeline as well. Thank you. All right, Dr. Keppel, please come on up. All right, I think there are a few slides on select data on Tavalese, which you guys are probably already familiar with, so it will be more of a quick review. First, in terms of indication, Tavalese, as you guys know, is a kinase inhibitor, specifically the spleen kinase, and the active metabolite of Tavalese is what disrupts that destruction, and by doing that, it's actually directly addressing the disease mechanism itself, and as far as indication, it could be basically second line or after based on all the reasons that we just discussed, and for patients, obviously, who had insufficient responses, and as you know, most of the patients, about 80% of patients who relapse after first line treatment with steroids. This kind of gives us a quick overlook of what the treatment landscape looks like right now. So, on the left upper corner, you have all the immune suppression mediated treatment modalities, including your IVIG, steroids, and Ritaxan, and also, even though I think splenectomy is now falling, you know, way back on the treatment option, and at least me personally, I always discuss this as an option with patients, and I don't have a lot of patients choosing it anymore because we have so many effective therapies, and I don't think there's excitement to get their spleen removed, but if you have a patient who may consider that, I think that's a legitimate option still. And then on the lower right corner, you have your TPO receptor agonist, which basically works by stimulating the platelet production in the bone marrow, and to some degree, it may address the disease mechanism because part of ITP is you do have the megakaryocyte dysfunction, so it could partially address some of the disease mechanism, but in terms of directly addressing the disease mechanism, tabulase is the first one. It's novel in its mechanism of action, and it does address that by directly addressing the spleen kinase, but I think the spleen kinase is a little bit of a misnomer because people think, you know, everything happens in the spleen, but the platelet distraction can happen in the liver and other places, so even post-splenectomy, as you know, you guys are probably familiar, it does work for post-splenectomy patients because the distraction can happen anywhere, so I think it's better to, you know, probably to say it's a tyrosine kinase inhibitor because that word spleen seems to sometimes cause confusion. In terms of dosing, obviously, you would start with 100 mg BID for four weeks, and if the patient does achieve that response that you would expect, then you would stay on that dose. However, the majority of the patients on the FIT-1, FIT-2, and the combined FIT-3 data needed the higher dose, which is about 88% of the patient population. So, 150 at 12 weeks, you either have to achieve the overall response, which is the 50,000 plus, or you may have that over 30,000 to 50,000 with clinical benefit. If you don't achieve either of those goals, then I think you should discontinue tablets at that point. But in terms of, you know, patients missing any doses, they can take the next scheduled dose. They don't need to, you know, hurry up and take and possibly have, you know, more side effects because they take it in a short interval from the next dose. Other, you know, in terms of the clinical trial, the rescue medications and other stable treatments were allowed, so I don't think I have used, you know, a combination of treatments, but if you have to use rescue medication or if you have to use other medications along with it, that will be written about. So, now... I do have a question for you and for others that have had the Tavolese experience. I know in our clinical trial, it was 88% went to the higher dose, and that was more... I think it was just more protocol-driven, per se, where the advisors were like, wait... Sorry, the primary investigators were... You haven't hit enough of a bounce on the plate. Let's just push them up to the 150. In your practice, though, do you see it more at the 150 of the patient experience or more at the 100? Most of my people have been at the 100 dose, so I think the way you're talking about the way that protocol looked like it was written, that stable response endpoint, they had to go to the higher dose at that fourth week. I think I've only had, I don't know, maybe 20% of my patients who've had to go to the 150 because I'm happy with a good clinical response. I don't need them to have a normal count. Oh, yeah. So, for those few people, those were people that hadn't gotten a response yet at the fourth week, so then I went up. So, somewhere in, like, four- to six-week range, I went up. I think my practice probably a little bit more at 150 VID just to hit that 50,000. That's my goal for during COVID. Yeah, I've had to dose-escalate as well. I think the people that I had started had a few unique circumstances in terms of bleeding issues, and to add to what Rick said, as part of the clinical response were other symptoms like fatigue that were also kind of being managed alongside of it. So, I was able to dose-de-escalate a few of those back down to 100. Can you talk to Travis on this? I've been at 100. Okay. And I just wanted to make sure that everyone's aware that there is price parity between 100 and 150. There is no difference and no increased cost to the patient to go up to the 150 or back down if the VID does sit. And that's one of the things that kind of gets... can be overlooked in practice. So, I didn't know on the pharmacy side if you guys have seen that or if you're aware of that as well. When we dose-increase and when we don't. For the patients that you do dose-increase versus those you don't, would you say the patients that are dose-increased have had more prior therapy failures? Because we know, obviously, the longer you have a disease, the more pre-treatments you have, the sicker you are, the harder you are to get a response in general. Is that true here or is it just a product of you just haven't got the response quick enough maybe? I think that you said the more prior therapy, the more of a fracture, the harder to get that. Those are the toughest. And with all other agents too, with the TBRAs, those are the toughest. That resonates to the clinical side as well. Those are the patients that happen to go up to the highest dose. You're more second-line patients. You'll get a perfectly good response. You're happy with that response of 100 mil. I agree on the refractory patients. Those tend to be ones who have had other lines of therapy before they've come to me. Yeah, I also agree. And that's a good comment in terms of the confounders because some people have such a severely low platelet count or a clinical presentation that's alarming. One gentleman comes to mind who kept having to be re-hospitalized, multiple different therapies. It was hard to say, well, what is he responding to now? We're throwing a lot of different therapies at him because he's so sick right now. Multiple prior therapies. Yeah, I think I can speak to that too because all the second-line people that I have given, they were able to respond with a lower dose. A guy on the speaker slide deck, he's been on it almost four years plus now, but he's actually now on once a day and still cruising. And also what I tend to do usually is if I started at 10,000 platelets and four weeks later I'm at 35,000, I'm patient to see if they will have ongoing improvement before I escalate, as you know. The other question I was going to ask in regards to this, one of the things that we noticed, and it still does exist, were that the providers are not necessarily familiar with the tabulese data. And when I say familiar with the tabulese data, in the mindset of looking at a clinical response almost being that of a T-po, and as a sick inhibitor, you're not going to get that bump in platelets. From a marketing standpoint and training the sales force, do you think it's pertinent that we truly almost lead with this, treat them for 12 weeks with fostamatin before giving up, or do you think already it's well accepted by providers that it is a, you know, how we have it here, if that week four you're not getting the clinical benefit, go to the higher dose? I know a lot of people don't see it that much, right? So I don't think they know that. You know, up-to-date tells us. That's what we get. It's pretty clear and up-to-date. But, yeah, I think you guys should reinforce that. I think it's also the anxiety surrounding the numbers, right? You know, not only from a, perhaps a physician who may not have the body of experience with it, but also the patients fixate on the numbers too. We want to say, you know, our threshold of comfort with it is that the platelet count is about 30, for example. You know, I'm saying, hey, you're in pretty good shape if you're not bleeding, but, you know, numbers are important to patients. I think that's where 12 weeks seems like, hey, that's a long time. So buckle in, you know, and be ready for that. Especially other providers, the PCPs, they freak out. They say 30, that's not good. Oh, yeah. We spend more time treating PCPs than we do. I can convince the patients that 20 is okay or 30 is okay, but... And then, Pat, we end up being the ones that need the X-rays. Yeah, and I think the other thing too is, of course, you know, we have to have a study, but I felt like, you know, if you get a robust response and having any sort of side effect, de-escalating a little bit, dose-reducing probably works, and one of, I mean, it's anecdotal, but I have a patient who started, had a very excellent response. Four months later, he had insurance change, and he was scared of all the financial aspect of it, and he's like, hey, can you just stop it and watch me? And this guy stopped, like, in June, and I just happened to see him yesterday in the clinic, and he's still keeping upper 200 and 300 range. So I feel like maybe disrupting the disease process is given as a time, so is that going to be a durable, permanent remission, or is he going to relapse in a couple of years? But still, you know, those are probably a lot of things that I felt like could be looked at, you know, metabolism, and if we can make it a one-year or two-year treatment, I think that would be a huge selling point, because a lot of times people hate, you know, committing to a medication, one, for the side effect, but also the financial taxes is the aspect of it. All right. So now we do have the five-year data for Tavalis, and the good thing with Tavalis is, you know, once you get a response, you can be assured that most of the patients are going to, you know, stay in that response, and here what we have is the three lines. The top yellow line is the people that have reached that 50,000-plus threshold, and as you can see, it appears everybody's maintaining their response, and similarly, the people with the clinical benefit in that 30,000 to 50,000 range are also maintaining their clinical response, so once a patient achieves, you know, the desired or the target goal of platelet or the, you know, clinical response, chances are they're going to stay in it, and you can feel confident about it, and that's the other good thing about it is, if you're not getting any response and no clinical benefit, I think it's okay to discontinue. In terms of percentage, you know, if you look at the overall study, about 44% have reached that 50,000-plus platelet threshold, and another 26% have achieved the clinical benefit, so combined 70%, but of course, you know, we know that this were very relapsed, refractory, mostly like in the third, fourth line, you know, scenario, so because of that, there was a post-hack analysis done on the data to see what kind of response do you get, and as you can see on second line, in terms of achieving that overall response of over 50,000, that's about 78% of the patient population, and when you combine that with the clinical benefit, that's almost all patients at 94% in the second line. As you go to third line, it's 64% and 86%, fourth line, 52% and 59%, and of course, you know, for the whole study population on the fifth one, you know, you can see that the overall response of the whole study population on the fifth one, fifth two, and three, 54% have achieved the overall response of platelet over 50,000 and 70% clinical benefit, so it still is pretty robust response, especially in patients that are considered to be pretty refractory to a lot of other treatment options. Aaron, I wanted to add in here and ask a question from a marketing standpoint. Of course, now, this is from our 2019 data, and just recently, we partnered with a company out in Japan, Kise Pharmaceuticals, and the Japan regulatory agency, what they make you do is another phase three. It's not just based off of the U.S., so they completed their phase three, and it was recently published. What was interesting, right, on our end, in corporate, you're actually like, well, does our data hold true in another phase three trial? And actually, the Japanese data did hold true. In fact, some of their numbers are slightly higher on the 50K as well, so like the 78%, like 81% response rate in an earlier line, and there was also another 180, I believe, patients are in it, so it's another larger study and not a small N. But what was interesting to me was the, I understand, sure, you want your product to be used for a long time, but at the end of the day, the T-Po's have had an 18-year run of habit, and then you're hoping that you can kind of blunt that habit and go, hey, after a T-Po utilize, probably. When we were launching, a lot of providers said, well, yeah, yours is 78%, but I get 90% of the people to the goal I want with the T-Po Mimetic. 85% of my patients get there. However, in that third line, I found it really intriguing back then was, I don't see the number, if I use a PMAC or an NFRATE at the time, of getting to 65% in the third line. I actually see less. So is there something potentially focusing in from a marketing aspect of just that is, like, Doc, take a look at this third line experience with Havelis, and how does this resonate with your current clinical experience? I think it's compelling. I'm looking at it now, and I'm like, wow, so I think a lot of people are cycling. I think they'll talk about that. They say, well, this is not working, let's cycle to that. I'm sure the response rate is much lower to cycle compared to this. So this resonates to me. Okay, great. Any other thoughts regarding that? Honestly, I think if you look at the clinical trials for T-Po receptor agonists, it's about 80, 85% response rate. I think it was about 66% that was there. Yeah, somewhere there, 70 to 80, yeah. I think that's compelling. I think you need to couple it with duration of response, though, too, because if you're talking about sequencing, and one's better in third line than the other, then that's kind of a counterargument that you need to address. Yeah, and what we saw was in our data, and it's just not kind of broken out in a graph in a publication, but most of the patients that are in the third line of therapy are in that five-year analysis, fourth line of therapy, because it's all comers. So you do see that you may not get the full seven. Now we have certain patients that are now out there, and I know the N is very small, but they are six, seven years out on therapy as well. But those particular patients were later lined, but it's just the onesies, twosies that are still being followed Great. So in terms of, of course, adverse effects are as important as the efficacy for any drug that we want to use for our patients. For TKI, actually, I think the side effect profile is pretty acceptable in terms of the majority of the side effects are mild, but there are a few that are considered moderate, and the two most important adverse effects that we have to watch is one is diarrhea, and the other one is hypertension, and they both are manageable in a close follow-up in the clinic and given the patient's guidance. The rest of them, in terms of moderate, severe toxicity, we're looking at low single digits, and in terms of laboratory parameters, I think monitoring the LFTC is important initially, particularly at least check them monthly, but after that, as a matter of practice now, I don't necessarily check my patients with LFTs every month. I check them every three months or so, and I haven't had any problems personally where people may develop a liver function problem a year later, so I think, and I don't know if you guys can help me in terms of timing of when that may happen, but we're looking for people with hypertension that have been able to manage by adjusting their medications. The other important thing is in terms of risk of thrombotic events. In the post-hack analysis, in the phase three studies, there was one out of the 146 patients who was treated with fostamatin that had a minor thrombotic event which was judged to be unrelated to treatment. He had a lot of cardiovascular risk and thrombotic risk, so the patient that I have on the speaker deck, that was the reason, actually, I decided not to use TPO mimetics first because he already had AFib, he had peripheral vascular disease, he had vascular procedures and all that, so he was a patient that you want to get better in terms of platelet count because he was on anticoagulation, but he was also a patient that you don't want to overshoot in case of possible thrombotic events. That, to me, is a very important point, but something worth considering for all the patients that we see. The patients who had thrombotic events, did they have a splenectomy in the past? That's a good question. I don't think so. Is this comparable to your clinical practice? Is there an AE that may not be listed here, but you've experienced that you think might be drug-related? In the mild, I'd say grade 1, mild is grade 2, and 3, 4, that's how it is. I had a question about the epistactus, for example, and Kyle, perhaps you can shed some insight as well. From a mechanistic standpoint, there is, at least in the theoretical sense, the sick inhibition has some plight with inhibition as well, functionally, at least theoretical, but I don't know how much it's seen clinically, and other doctors, feel free to chime in if you've seen paradoxical bleeding happen with it. I always like when compared to the TPRAs, it's very similar. What you see is the disease process itself, even the headache, I saw that with that one. Epistactus is catching it at the tail end before the response happens. Yeah, I think those are probably, like with any study, you're going to document all episodes, but I think it's more disease-related than treatment-related. And I think that the theoretical plight with dysfunction or inhibition has not really panned out in a clinical sense in terms of preclinical versus clinical. All right. And in terms of, of course, we care about the bleeding episodes in ITP patients that we are treating. Across the board, tabulase did better. When you look at all bleeding, it's 21 versus 35 percent, mild bleeding, 12 versus 80 percent, and the moderate, 9 and 10 percent. But the severe or serious bleeding was zero with tabulase. Even if you don't achieve that threshold of 50,000 plus, getting them to 30 to 50,000, I think, could help avoid all of the serious bleeding complications. And similarly, in terms of needing a rescue medication, it was much less on the treatment population with tabulase at 16 versus 45 percent. All right. I think that was it. Any questions? In terms of data or potential questions that you may have just in general for us based off of the data? I know this is old data now, so everyone's pretty familiar with it. Any outstanding questions out there in terms of patient management just based off the published data that was in the clinical trial? Just a curiosity, off-label, do you guys have any other investigator trials looking at any other uses? Is that something still percolating anywhere? Yeah. So, yeah, we partner right now with the NIH who are doing a number of different types of studies in all sorts of areas where they do stick inhibition in the person area. In terms of something maybe more closer to home, I think maybe the group here is familiar with the fact that we did have a clinical trial. When that came out, unfortunately, our primary endpoint came out negative, but when we took a deeper dive into that, it was kind of compounded by the fact that we had European sites that were given rescue medication right up until day zero, but then we had placebo patients who had a response. Well, of course they did. So when we factor that out and we just look at US and maybe more Western Europeans, we actually had a positive result. So hemolytic anemia is certainly an area of, I don't want to say continued interest, but it's definitely something that we've been thinking about. We've got our data in COVID, and COVID is kind of very much behind us right now to a certain extent. There was positive data there. It's just too slow to come up. We handled it, and that's good. I mean, obviously there's other areas in the world. What else? Evans? Hemolytic anemia and ITP, obviously Evans is going to come up. So I mean, there's a lot of potential. I mean, you know, when we talk about the toxomab, the term vitamin R comes around, right? There's a, you know, a sick pathway from a biochemical standpoint. And I was just going to add on the hemolytic aspect. As an organization, what we're looking at, we went to the FDA, made the argument, but the FDA said no. And it was, I think, by math, was actually the two patients, and they were those Eastern European patients. You remove those statistically, it's a positive trial. And they just said, no, it's not happening. But we have, the medical affairs team is now submitting a package for compendialistine. So we're hoping we get that. And it was kind of ironic, at ASH, our publication hit of the hemolytic anemia paper. So just while we were walking the conference, the doctors would be like, oh, you got an indication of hemolytic anemia. We're like, we did? It's worth $9 million worth now? We're like, what's going on? But no, it was just, you know how it is, you get the alerts that this is now published. And so I think everyone just caught that on their email and then just assumed it was positive, not knowing that it was already a negative trial from that. And the FDA is basically, it's not one of those like, oh, just do another 10 patients and let's see what happens. And by the time the trial will get done, I think we'll have like one or two years of exclusivity left. So it's just not even, the cost doesn't make sense. And so I just want to add, I mean, with COVID, for example, when we were looking at it, COVID wasn't the big picture. I mean, it was a stepping stone. I mean, where we really think thick inhibition and foster plays a role is ARDF. And, you know, so we were looking at these severe COVID hospitalized ventilated patients. And it was really a stepping stone. So that research in terms of ARDF, that's certainly ongoing. And that's obviously an area. The other thing I really can't say much about, I just heard it in the hallways, apparently, was radiation poisoning. I don't have a clue what thick inhibition was to radiation poisoning, but it's been looked at. So again, it just talks to the fact that there's a lot of utility in terms of kind of a research strategy, at least from the medical side moving forward. I mean, Sanjeev already talked a little bit to, obviously, our partner T-State in Japan. And, you know, they've adopted this drug and they've had tremendous success with it in the commercial space, partly because of the drug's own merit, but also because of the fact that in Japan, they've been pairing it up with a T-pill. Now, Japan doesn't have Avatron, because they're definitely thinking about what happens to their market when the doxor is hit, but physicians are able to prescribe Promexor and Tava together, and apparently that's quite a common practice out there as well. So we're interested in potentially doing that type of study. And then the other study we're thinking about doing, obviously, we don't have a pediatric indication due to bone plate closure issues, but if we did late adolescence, you know, 15 plus who have already gone through puberty, we could potentially have a late adolescent additional supplement to our PR as well. Awesome. All right, Sean, let's do the other video. They're on the folder. So we've got two parts. There's the green part and the red part. And what we'd like to take a look at is what's the difference between why you expect your child to go through puberty and how you can work on and then on the red part, what we can do to prevent that. And we'll spend about five minutes to get through why we think you should not go through puberty. We requested we all do this every week. Yeah, when the marketing team came up with this exercise, I'm like, you realize this is doctor handwriting that you're reading. It's famous, right? You need to get the right What happens when you can argue your points We'll tear the card in half and stick it together. Let's have a conversation about that. I think that's a good point well made so we can talk more about it. Okay. Maybe. Not yet. Maybe. We'll be able to tell you it won't be anonymous. If you don't just let me know and I'll start grabbing cards to pick them up. Thank you, sir. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. Wow. 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Wow. Wow. Wow. Wow. Wow. Wow. What we really continue to call out, and this is what our market access colleagues are trying to champion, as well as our sales team, is to remind not only in the clinical discussion after they've had that clinical discussion and efficacy discussion, but rather coming through pharmacy or techs and reminding everyone that this is a limited distribution network. So Rigel only has two specialty pharmacies. The pharmacy we want the patient to go to to fill a prescription for any one of our drugs is your in-house medically integrated dispensary or pharmacy in your practice. That is our first choice. So we've got GPO contracts with everybody, and we are limited the distribution network so it can stay with you. So for example, CVS, you should be able to get an exception to fill at your site because we don't contract with CVS. You send a script to CVS, CVS has to send it to Biologics or Optum. So for the patient that gets really confusing, right, because they've been now punted twice or warm transferred twice to get the fill done. We'd rather have your practice fill it, whether it's Rx to go or your central pharmacy as well. We do, and sample program is out there. We did have vouchers that went away at the beginning of this year, but a sample program is easily executed at the local level. That's where having that relationship with a territory business manager is very helpful. They can work through that. And the Rigel OneCare back end services helps with co-pays, patient assistance programs. So all that sits in the background, and it is actually a pharmacy that you're working with, and you're working with some nurse navigators to help get drugs approved. So if you use Rigel OneCare and you fill out the form and send the tab release prescription in, and your pharmacy can fill it, they will transfer the script back to your pharmacy for fill after you've decided whether or not you want to fill it. We're not taking the script and sending it to Biologics. This was a conscious decision we made in concert and consult with ENCODA, COPA, when we launched, was to keep very limited distribution network and then focus on the pull through there. But the message doesn't get out. There's so many that still don't know it. So our sales team is kind of focusing here and reminding everyone what's out there, and then when they are asked, or when they're having discussion with clinicians who are asking about if you have something with a GPO, we have a contract with all three GPOs for an opt-in voice discount, 5% is the baseline, all the way up to 17%. And if you are in aggregated large network, like AIM, or Athena, or One Oncology, everyone has the same range, and the volume tiers just change a little bit because of size. So that was a big step for us this year, is to actually look at those aggregated pieces. And one of the reasons we're having the discussion today is to try to figure out, is there a message opportunity outside of what I just shared that would resonate in AON practices, that would resonate in Athena group, or even your own institution where you may be by yourself, in the case of Hyland's. What's going to resonate from this marketing, market access message? Not in the clinical discussion, but how should you be communicating this to you, because you're driving it into pharmacy and then pulling it through, I guess. Yeah, I think there's going to be, I think there's going to be a lot of differences between AON and One Oncology. So, I guess maybe, there might be some opportunities to either, for example, with that group? Yes. So, actually, I would turn the question back to you as a QCCA member. Have you heard any of this RWE information? Because again, this isn't something that Cengie on the marketing side can say, and what we've had actually asked of the network is, this is your data and your publication. We helped sponsor it and have a vested interest. How are you communicating that to your membership? Question 23, went into print, September. Okay, so I'm curious to see, I'm going to be in April, so I'm curious to see what the response out there, and how much time. I think that's an opportunity, because I know there So, if I could peel the onion one more there. Let's just assume that the QCCA network, we come up with something creative, and we work this. So, you have it in place. What does pull-through look like? Because FDS has this in place, but we don't see the pull-through, right? So, yes, the offering is there, but how do we tactically pull it through to get the utilization? Is this going to be more of a partnership at your level, at the practice driving down from pharmacy? Is it Dr. Travis kind of, you know? When you walk in, when the rep walks in, other reps do this, the first thing they need to say is, you can prescribe this through your pharmacy, first statement. Two, you can use it second line, and here's the data, three. They might come back to the only challenge, but the main challenge for us is, reps don't have access, right? They don't. Yeah, of course. Okay. Okay. Kyle, from your perspective, taking a look at the contract. Yeah, so, I think you need more airtime from the GPOs and aggregators, for sure, and that's kind of what we've been talking about. And your contract, I think, is really good in terms of the total potential value, but the challenge that we have, and there are pros and cons to being part of an aggregator, and in this situation, we're not, currently with our aggregator, we're not performing above tier one, right? And the tier one value of this contract is actually lower, the total value is lower than where we're performing on the others. And so, you just don't have any momentum in tier one. On this contract, you need to get to tier three, and then it's amazing. But you have this huge barrier where practices are individually saying, okay, there's some opportunity here, but I can't get there myself. And so, you have to rely on the whole aggregate, and it just does, you don't get the momentum. So, in my opinion, you need to eliminate tiers one and two, and then you have everybody's attention. With tier three, it's amazing, and then you get to tier four, and it's even better. But you're just not going to build momentum without that starting value has to be better than the others. Very fair, and I appreciate the feedback, and I guess I should have prefaced, this is something new for us at Rigel this year, starting recognizing the aggregator. So, we can't retrospectively say, here's your baseline, we didn't go that route. So, the baseline is being established right now. So, everyone is kind of on whatever pricing they were in Q4 into Q1. Q1, with the aggregators, and Fluoric Cancer, and Aon as well, are all being set right now, so that it's one month off, so May 1st would be the price update. So, you could be hitting tier two, tier three, based on this baseline performance, and that's why we're trying to let practices know, and systems know, we are here, we've recognized it, we've set a plan here to kind of set a baseline, that's what you're in right now, and then we're going to move forward. We didn't show off at the table, and just to be transparent, coming at tier three, we'd be giving away the farm on the front end, in hopes to make it up on the back end, and that pitch to pricing committee and senior leadership felt very flat. So, here's our slow ramp up to get to... Yeah, you have a great, it's a volume contract, right? You have the limited distribution network, you're good partners, you have all of those boxes checked, but when I see companies that really move the needle, there's upfront value, and that's the one piece that I think you're still missing, is just, because I'm looking at Athena's scorecard, and what they anticipate we'll achieve, it's not tier three, you know, and that's where I want to be, at least. So, that's just a little bit kind of like, okay, well, what do we do with this then? It's just not as interesting to try to move, to try to really make a push for it at the practice level. Okay, no, I appreciate that feedback. And it's not like, you know, you look at the JAK inhibitors, which maybe are comparable in a competitive space, hematology kind of thing, and the newest JAK inhibitor is unbelievably good in the value, and they're getting a lot of attention. They're getting these conversations that you guys are talking about, wanting to have. Which one? The OJARA. Oh, yeah. Yeah. That one makes me very sad. What's that? No, it's a great question. So, let's just assume, fast forward six weeks, eight weeks out, Sean is able to convince you in your leadership, and we're coming in at that tier three, right? If you could just go back to that slide. Sure. So, we're coming in, you're seeing this nice aggressive 9% discount thing. I'm just purposely playing devil's advocate right now. When I look back at the data and some of the, how we're looking at it, like with QCCA, for example, right? I'll be honest with you, there are certain practices I've never written. We went to the meeting last year, we had a discussion, right? This is surprising. None of us have written, right? As we were going through this project. And so, even when we're seeing those 17 practices and this data as we looked at it, it is very driven by three, four practices, and it's not as if all seven, right? So, totally agree. Because the comeback every time we present something, they go, well, but there's no history. And I understand it. I know why there's no histories. One is definitely just brand awareness, like this nice robust discussion that we've had. But then that's my struggle coming back to me, is like, how do I not get the brand awareness there? So, is that right approach top down from the C-suite, where you're writing that email saying... So, here's what's going to happen. You're going to wonder, you know, we're going to have a terrible conversation. You know what I mean? You're going, guys, we have a... Okay. Right? And so, here's what it is, you know, here's what it looks like for the last day. Right? It's telling me that when you talk about, you know, it's all... Yeah. Right? And so... Yeah. Yeah. Yeah. Because we've already presented this to Aon, and Aon has now basically said, you're only getting one T-po, and then you're going to get Tavolis, and the pharmacy's going to be actively calling the practices thing. And we're not saying pick or choose a T-po, like, right? They're just saying, you have the option, all three T-pos are available to you. Whichever one you want, you get the T-po, and then it's Tavolis. Because the value is there. Yeah. Yeah. Yeah. Yeah. Yeah. And Rick, with FCS, I think we'll just, we'll have a follow-up meeting with you and kind of plan this of how can we best get the worst to the providers, because from an FCS standpoint, they're not necessarily there from a pharmacy community if you're getting down after one T-po currently, so maybe it has to be more of a partnership with the senior practice members. Because I, just to your point, Kyle, like, when you're actually seeing the whole number, and if you just, because it's kind of interesting, like, when I asked Sean McCabe, what does it mean to me as a provider in a group? How many patients does it really mean? Right, so if you actually look at that, one to ten bottles, and this is our general GPO contract, this is not the aggregated account, but one to ten bottles is three patients, 3.2 patients, and that's starting and staying on therapy. So it's not a Herculean ask of my gosh, you need to go find 50 patients. No, literally, if you had 10, 15 patients, you are rolling right into that seven to nine percent range on Tavolese, and some patients will come off, other patients come on, so folding Tavolese, to your point, into an algorithm or thought process or what's going on in AON already of, hey, if you go here, here, and then you add Tavolese in, it's going to be an actual uptick, and it's only a couple of patients that need to be added in at each practice in the global nature, like we chatted earlier, Kyle, it's not going to take much, because there's so many that it's never even tried, so is there that opportunity? Do you have any practices at 84 bottles? Are there any questions? When you see our stock hit five, you'll know. I think some of the ones that we've taken a look at, like from a one oncology network, even at AON, they're in that 50s to 70s, depending on when the data cut is put there. I'm just thinking about, you know, how many people have ICT and stuff, you know, like, have a hospital-based... No, you know what, we have not really had a chance to look at that, from a hospital-based practices. Oh, so, very interesting question, and a good one. So, I mean, you've got some interesting games that are played in the hospital system, right? You've got 340B, and they run 340B pharmacy, which can contract anywhere, and then you have a few folks like Mayo, who is a health system, a hospital, but they still have their own GPO oral pharmacy that sits outside. Ohio State does the same thing. They've got a pharmacy that sits outside of Ohio State, so they can choose a GPO contract, and, or hospital contract. 340B, yeah, so there it gets really, that's where we were really focused on the community oncology. Yeah, and we've spent the bulk of our time in community oncology, trying to move it forward, because ITP is a community oncology piece. We don't say that, yet, earlier we talked about, the first time you get it, it is a consult, see now, immediately, platelets, and you're like, it's tiny, it's, oh man, I got that, I got that one. Do you ever have those patients, who are seeing a lot of therapies, they go to an academic center, and they say, hey, get an opinion, and the person there says, it's telling, and then they go back to the office and put it? I, you know, I think it's very, very rare to see these patients, from our experience currently, getting to an academic center, and then coming back into the community, because they end up just being enrolled more into these clinical trials, what limited trials there are, and then even from, you know, you have all these centers of excellence, whether it's myeloma, or AML, in all the communities, in the major cities, but there's not many benign hematology centers of excellence, so that makes the others struggle, so you're not really getting to that. That's about it, right, so it's very, very difficult in that regard, but I think this has been great, we're right on time, so I appreciate that, I just want to say thank you for everything, first of all, that you do for your patients and their loved ones, on behalf of Rigel and my colleagues, the feedback you guys have given, you've actually like re-energized us in this regard, because it's the first time we're sharing this data, this is new, and it looks like it is extremely compelling, we'll go back and talk to both our medical and market access leadership, the data, believe me, if I could market with this data, I could, but FDA will not allow that, but let's see how we can partner, certainly with the QCCA discussion, we'll certainly have that as well, because I think this is, I don't want to say the final hurrah of Pavolisi by no means, but I think this, with the QCCA data, already having their five-year data, and now with this contract, I don't think I can come back and say, here's this nice car, do you want to buy it, I can't put any more options into this car, right, I mean, you can always add in a little bit more from the data sets, the way you said, analyze it, but it's like, I'm delivering the Mercedes, are you willing to buy it, now, let's chat, right, so, but I appreciate the feedback, and I think there's a lot for us to accomplish here in the next couple of weeks, and we'll keep you updated. Thank you. Thank you. Stay at Pavol's home, everyone. Thank you. Thank you. Nice to meet you. Nice to meet you. Nice to meet you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
