Hello everybody, and welcome to the Olanzapine LAI TEV-749 phase III SOLARIS Data Presentation Conference Call. My name is Elliot, and I'll be coordinating your call today. If you would like to register a question during today's event, please press *1 on your telephone keypad. Now I'd like to hand over to Christopher Stevo. Please go ahead.
Thank you, Elliot. Good morning and good afternoon, everyone. Thank you for joining us for this call. In a moment, I'll pass you on to my colleague Dr. Eric Hughes, who will introduce the other speakers. I just want to let you know we'll be making forward-looking statements during today's call, and we undertake no obligation to update those statements after today's call. If you have any further questions on our forward-looking statements, please see the appropriate sections of our SEC filings under Forms 10Q and 10K. With that, my colleague Dr. Eric Hughes, the floor is yours.
Thank you, Chris, and thank you for everyone joining today to talk about our SOLARIS phase III data safety and efficacy that we presented recently at the Psych Conference in San Diego. Moving forward, before we get to talking about our program for schizophrenia, I did want to briefly highlight the strong neuroscience legacy we have at Teva, starting with COPAXONE and AZILECT in the past, and now with AJOVY, Acetaminophen, and UZEDY in our marketed products. Looking forward to potential approvals for UZEDY in bipolar, and today our program in phase III for Olanzapine LAI. Not to forget, we have Emma Schulman developing in phase III for multiple system atrophy. This legacy has given us great capabilities in our R&D organization from preclinical to clinical and approved products. It's been a great opportunity for us to build upon that legacy.
This is not just in the United States., but in the EU and the rest of the world. Moving on to what we're going to talk about today, and that's schizophrenia. Schizophrenia, as many of you know, is a devastating disease, frequently for the patient as well as the family members of those patients. It's a complex disease. It has both positive and negative symptoms. It has cognitive implications, and it also affects the mood of patients suffering with this disease. All of these contribute to the functional deficits that really impact the quality of life of these patients who suffer with schizophrenia. Moving on to why we're so excited about what we can do for the treatment of schizophrenia, it's important to remember that schizophrenia is frequently a progressive disease that is exacerbated by relapsing of the disease and then the progression of that disease.
Remember, every time a patient relapses, it makes it more difficult for that patient to be treated, and it progresses their disease. It's also important to remember that 80% of patients, despite treatment, frequently relapse multiple times in the first five years of treatment. What can we do about that? The things we can do about that is help with adherence, because we know that adherence is important for the treatment of schizophrenia and preventing those relapses. That's what brings us to Olanzapine LAI, our new formulation that we studied in the SOLARIS phase III study. This program and this formulation were designed specifically to show that we could make a subcutaneous injection of Olanzapine that prevents the possibility of having PDSS. That's Post-Injection Delirium and Sedation Syndrome. Why is that? First of all, this is a subcutaneous injection that's easily given, and the formulation rapidly aggregates.
It's a very controlled release of this formulation so that you don't have any spikes in the exposure to Olanzapine, and that's what we believe drives PDSS with the currently available injections. If people want to have a clear and more elegant video to watch about the way that this formulation works, we do provide a link on this page. If you write to Teva, we can get you a password code to look at that link and see how the science behind the injection works. Moving on to what are the results and what we're excited about at the conference this year in San Diego, it goes from preclinical all the way to the clinical results. As I've talked about before, this formulation, when you're comparing it directly to the currently available LAI, you can see in this graph to the left that the currently available formulation rapidly dissolves.
This is a study in vitro, rejected formulations directly into serum. In this worst-case scenario, you can see that in the green, there's a rapid dissolution of the currently available LAI, but with the new formulation that we have developed at Teva, there's a very slow and continued release, even in this worst-case scenario. Going on this in vitro test now, across the entire program for our Olanzapine LAI formulation, we have over 4,000 or approximately 4,000 subcutaneous injections where we've seen no PDSS. It's important also to remember that the efficacy for all three doses was spot on and statistically and clinically meaningful, and that with this data, we're confident in the safety profile and the efficacy of this formulation.
I hope you can feel the excitement we have for this program and the potential of really opening up a whole new avenue of treatment for patients suffering with schizophrenia. With that, I'm going to pass it off to my colleague Chris Fox to talk about the opportunity for Teva that this presents.
Thanks, Eric, and good morning, good afternoon, everyone. Eric, before I start, I just want to say thank you to you and your team. You guys continue to do amazing work in addressing unmet needs and advancing medicine, clearly with your know-how, but also with this technology, and we're really excited about it. To frame it up, I would describe this opportunity as really unique for Teva at large to have a best-in-class LAI franchise, not one medicine, but two. Underpinning that is with two very well-established molecules with a wide range of patients. All of you know and are familiar with UZEDY, and that really suits for patients that are on risperidone or paliperidone. They might be somewhat controlled but desire additional convenience or more sustainable control by being on an LAI.
Many physicians characterize UZEDY and their use as the fastest and easiest way to get to a therapeutic optimal dose. On the right-hand side, we see Olanzapine being an incredible complement to this. Patients that might be appropriate for Olanzapine LAI will certainly be folks that are on orals or not suitably controlled on other orals and need more control. What we've seen in the research and from physicians is they particularly like this molecule for patients that present with agitation or aggression. We see this combination being really powerful from a breadth perspective and offering new and innovative options for patients. When we think about the opportunity, I'd like to start with characterizing it just on the overall approach and the unmet need. As Eric said, schizophrenia is a really severe mental illness that obviously is devastating for patients, their families, and society as a whole.
You can see just based on this bar graph, high unmet needs. Further, if you look at the graph, you can see that the market represents a significant number of patients with roughly similar numbers of treated patients across the U.S. and EU, and the propensity most notably in the EU to favor the use of LAIs. If you ladder that down one rung, you'll notice that oral Olanzapine usage both in the U.S. and EU respectively, and then certainly the percentage of LAIs. You can see some variation, but overall, really a significant opportunity, and we see this as really being a significant opportunity from the perspective of quicker utilization and broader adoption of LAIs. One of the things that makes this so complicated is when you look at kind of the patient journey, you know, across the board, how do we help and intervene with these patients?
The left-hand side is meant to take kind of a look at the patient journey. This is a very, very simplified perspective, and you'll see all the squiggly lines kind of representing inflection points that affect treatment and ultimately control for these patients. Most of these patients start seeing symptoms in their late adolescence or early teens, and they're often misdiagnosed or treated for depression or anxiety, and it can really take years. In fact, what we see with schizophrenia is that in many of the treatment reports, it can take an average of eight and a half years between that first onset of symptoms and the starting of treatment. You can appreciate that that's obviously a really, really difficult pathway to take. Why we spend so much time on this is we think we've taken the time to service these patients and the physicians treating them by understanding this.
We've used, you know, UZEDY as our foray into this market, and this deep understanding of the patient journey along with differentiated products really lends itself to us being in a unique position from a go-to-market perspective when we're anticipating the launch of Olanzapine. I'll close just by saying that, you know, we're really, really excited about this opportunity. We think that this is a really unique position to be in on answering these unmet needs with a differentiated LAI franchise. We know that we can address a broad spectrum of patients. Most of the patients will either be able to benefit from UZEDY or Olanzapine, and as I've said, we think we have a really excellent go-to-market capability and opportunity to really be a leader in the psych space and advance that as we go.
Now it's my absolute privilege to introduce our keynote speaker today, Professor Christoph Correll, who is an incredible leader in the psychiatry space. He has multiple appointments, including Professor of Psychiatry at Zucker School of Medicine in New York, Chair of Child and Adolescent Psychiatry at Charité Berlin. He is a prolific researcher and has something to the effect of 900 peer-reviewed articles, and we're delighted today to have him be able to speak as our principal investigator leading the SOLARIS study. Welcome, Professor Correll.
Thank you very much. I seem to have had trouble signing in with my internet. I'm really sorry about that. I'm really privileged to talk about the SOLARIS study, which I believe is a milestone in the treatment of schizophrenia, which, as we've heard, is really troubled by a lot of relapses that have to do with mortality, poor functioning, and also nonadherence. While we've had multiple long-acting injectables available to us, first generation, but also second generation, those have been restrained to risperidone, paliperidone as one family, and they are a preferable franchise. The Olanzapine, which has been used a lot for very chronically ill patients, has not been really available to us within LAI simply because we have problems with the PDSS or the Post-Injection Delirium/Sedation Syndrome, which can be potentially fatal when all of the Olanzapine that's injected can enter the bloodstream.
The subcutaneous formulation that Teva has been developing is really the solution to that because, as you've seen, even when you inject it into the bloodstream itself, its formulation really flocks out, and it can't enter the bloodstream. What we've done in the SOLARIS study is that we have two different phases. The first one was the FDA to show that the medication in that formulation works for schizophrenia. Basically, an eight-week acute study where you can see here that 20-point and more improvement in both and all of the three doses were achieved that were equivalent to 10 mg, 15 mg, and 20 mg. That was the efficacy portion. Obviously, we know that Olanzapine works. Check, it works also when it's formulated as a subcutaneous formulation. The question then obviously was, what about the long-term safety?
Here, we were able to show that over the next 48 weeks, there was very good tolerance of this medication, and there were over 3,400 injections and not a single PDSS. The patients who had been finishing the initial phase were then re-randomized, or they were continued on the dose, but re-randomized when they came from placebo. When we look at the safety of the medication, we can see that it was also very well tolerated. This is Olanzapine as we know it. There is weight gain that has to be monitored and managed and can also be, I think, monitored and managed as we know with Olanzapine because you know that this medication, despite the cardiometabolic side effects, is still one of the most used medications orally, but not yet as an LAI because of the issues that we've had with the deep intramuscular injectable.
You can also see that there are, obviously, as expected, also some injection site reactions. When you put all of them together, they were mostly mild to moderate, and also less than 1% of patients discontinued treatment either due to the weight gain and metabolic abnormalities, less than 1% due to injection site reactions, and also less than 1% due to sedation, which can be a side effect with Olanzapine. Overall, this medication was very well tolerated, and this was also confirmed in the SOLARIS study. Now, let me see which slide you're on now. I think I've gone through them. Is there anything else I need to cover? Hello? Can you hear me?
Yes, we can hear you, Professor Correll. Eric, go ahead.
Thank you. We'll now go into Q&A. If you would like to ask a question, please go ahead and ask one by one on your side. Sorry.
Oh, sorry, Eliyahu. Dr. Eric Hughes had the conclusion. Just a couple of slides before the Q&A. Eric, are you there still?
I think you're on mute.
I'll tell you what, I can do Eric's slides. Thank you for that, Dr. Correll. We very much appreciate that. We're also proud to say and proud that our colleagues' hard work with Olanzapine was honored and the hard work of the investigators and the patients who participated in the trials. We just wanted to mention that here. Very well done on the part of our colleagues. Next slide, please. That's it. Now it's time for our Q&A. Elliot, please feel free to go ahead and queue up the first question.
Thank you. If you would like to ask a question, please press *1 on your telephone keypad. If you would like to withdraw your question, please press *2. When preparing to ask a question, please ensure your device is unmuted locally. As a reminder, if you're using a speakerphone, please remember to pick up your handset before asking a question. First question comes from David Amsellem with Piper Sandler. Your line is open. Please go ahead.
Thanks. Just two for me. First, on the total number of injections, I think you cited 3,470 injections in the SOLARIS study experience, or maybe it was the overall clinical experience. I just wanted to clarify, I think you needed at least 3,600 injections per the FDA. I just want to make sure that you have enough injections and exposures to pass muster with the FDA. Just give us a refresher on where that stands. I think you do, just wanted to clarify there. That's number one. Number two, regarding LAI Olanzapine beyond schizophrenia, can you talk about bipolar and also eventually getting that into the label? Just talk more generally about the mix between schizophrenia and bipolar usage among the oral Olanzapine population if you can. Thank you.
Can you hear me now?
We can, Eric. Thank you.
Can you hear me, Chris?
Great. Professor Correll, maybe I'll start with the FDA question that was just asked. FDA has been in conjunction developing the program with us for many years. Actually, I'm in Zagreb, Croatia right now in the very labs that the formulation was developed, and they reminded me that the first time we interacted with the FDA on that very question was back in 2016, and they said that there was the possibility of developing a formulation without a black box warning or monitoring. That began the journey. You've seen the data that shows both preclinically and now clinically around 4,000 subcutaneous doses without PDSS. This is checking all the boxes that we've discussed with FDA with regards to what the safety and efficacy should look like.
Although everything is up for review with the FDA, we're confident in the data and the way that it's been developing over the years, and we're looking forward to their feedback. With your question about bipolar disorder, that certainly is an opportunity that we could entertain as a lifecycle management for Olanzapine. Just to remind you, we actually have already submitted that very indication for UZEDY as well back in February of this year. We're also looking for feedback on that program. I think that we're really building a franchise not only for schizophrenia, but potential other indications in the future.
When it comes to the use of this oral Olanzapine LAI with regards to where patients would come from with regards to oral, perhaps I could ask Professor Correll to maybe highlight how he sees LAIs entering the market, maybe particularly for Olanzapine, and what the opportunity is there for patients.
Absolutely. Just to follow up on the other question, the 3,470 injections were just in the SOLARIS program. Overall, with all these studies, I believe there are almost 3,900 injections, if I'm not mistaken. In terms of where Olanzapine LAI would, okay, great. Thanks for confirming. Overall, where Olanzapine LAI subcutaneous would now come from, I think there are multiple sources. I would certainly move over a number of my patients who are currently on oral Olanzapine, and most of my colleagues, I think, are waiting for that option too. You may remember that Olanzapine is used mostly for more severely ill patients that often have also more cognitive dysfunction, may not have as much supervision, and family members who can guide them and help them to remember taking the medication, and may also have fragmented illness inside. Here, having an LAI can be very helpful.
We also have a number of patients who are currently on either aripiprazole LAIs or risperidone and paliperidone LAI and still have residual positive symptoms where we think they might be able to improve further, but we weren't able to move them to an Olanzapine product because that wasn't available really as a manageable LAI. In that sense, I also assume that some patients might move over from those patients. There are others that, because of the lack of an LAI, would not have been tried on oral Olanzapine and therefore might also come from that third group.
I believe that here we have a treatment that will fulfill a gap and will also pretty quickly gain treatment users more than even with UZEDY because UZEDY has had to fight actually against five or six other formulations that are available at risperidone or paliperidone and still has held its own very nicely with music gliders, also because of the subcutaneous formulation. Patients might actually prefer that than deep intramuscular formulation. The ease of injection at the beginning, no dual injection needed, no oral co-treatment, no loading dose, no booster injection after one week. The same assets are also present for Olanzapine LAI, which I think makes it a very easy-to-use option now that many of us are waiting for.
Thank you, Professor Christoph Correll. Next question, please, Elliot.
We now turn to Jason Gerberry with Bank of America. Your line is open. Please go ahead.
Hi there. Thanks for taking my question. Maybe for Dr. Correll, I'm just curious with Relprevv, how much of the issue was the box warning and the safety fear factor of PDSS versus the post-dose, I think, three-hour monitoring requirement? My sense is that the monitoring requirement was the much bigger issue. I'd love to get your thoughts on the weight gain. You know, will that be a factor that you manage through patient selection, or would you use weight mitigation strategies like co-metformin prescription for these patients, or just pull patients off drug if there's, you know, the hint of metabolic parameters going in the wrong direction? Thanks.
Yeah. Thanks for the two questions. I believe that it's really a combination. The fear of PDSS, even though it's just on one in 1,100 - 1,200 injections, but that can be potentially fatal, is something that has made it very difficult to prescribe this medication. To then mitigate that, three hours observation in the hospital is just so hard to do operationally. What if the patient just walks out and says, "Thank you very much," and then we're responsible for them? I think it's really this combination of the risk and the risk mitigation strategies that has made it unmanageable in most settings. Therefore, not having either of the two is really freeing up Olanzapine LAI as a new option for us. In terms of the weight gain, this has been something that we know as it is a problem with Olanzapine as well as with Clozapine.
The two most effective drugs at the moment of the use of postsynaptic dopamine modulators have not deterred clinicians from using this medication. Actually, when you look at long-term studies with oral Olanzapine, Olanzapine has adhered to a longer generally, even than other medications. The weight gain is an issue, but it's monitorable and manageable. Many patients will recognize, especially when they're more into the illness, that yes, weight gain is something that has been happening with other agents too, and now I need to get my feet on the ground and be back into life. What we've also shown is that despite the weight gain, actually, the mortality is reduced with medications, including the high metabolic risk agents, because as patients improve functionally, they are going more to doctors to have secondary prevention of weight gain and blood pressure problems and glucose problems.
They also have less psychosis-related stress, so that's hormonal changes, and also basically have better lifestyle behaviors. In that sense, what we would do is improve their healthy lifestyle by giving lifestyle instructions. When patients are less psychotic, they can follow them more. On the other hand, you're right, metformin is something that we're now proposing very much at the beginning even of Olanzapine treatment because prevention of weight gain is easier than intervention. At the same time, GLP-1 agonists might also be an option to actually mitigate the weight gain.
Thank you.
Thank you, Professor Christoph Correll. Thank you for the question, Jason. Elliot, next question, please.
We now turn to Les Suleweski with Truist. Your line is open. Please go ahead.
Good afternoon. Thank you for taking my questions. A couple for Dr. Correll. How do you ensure, or how did you ensure representation across schizophrenia subtypes among the 675 participants? What strategies were used to minimize the dropout rates in the OAE study? To go back to the metabolic and weight effects, the 5.6 kg weight gain over the 48 weeks stabilized after week 32. Can you elaborate on the dosing impact between the 318 mg and the 531 mg? How does that compare to oral within your experience? I have a follow-up for Eric.
Thank you for the three questions. First of all, we used sites that have patients who come in and are exacerbated and need to be treated for their relapse. This is a patient population that actually agrees to be in the study. In that sense, I think it's very representative of patients in RCTs. Is it fully representative of all patients with schizophrenia? Most likely not. We didn't enroll patients who had suicidal ideas or who were so aggressive that they couldn't understand the study procedures and adhere to them. I think overall, the population is very much on par with other medications that we've seen. We know that Olanzapine, actually, the efficacy really translates from RCT data into the real world because it has such robust efficacy. In terms of keeping people in the trial and the long-term study, these are patients who are called.
They are in the study. They have agreed to it. We have seen with other studies too that Olanzapine is actually a drug that, despite the weight gain, patients seem to somehow feel well enough and maybe sometimes even better than with other medications, that they do stay in, and we've seen that in this study too. The third question, remind me, was about the stabilization of weight gain. Sorry?
I'll go. The stabilization of weight gain after week 32 and then in comparison, whether it be the dosing and oral.
Yeah. Okay. There has been in the literature a small dose-dependent effect on weight, but we really, I don't think, have looked at that in depth. If anything, the delta is not very large between the doses because all of them are efficacious. When you look at the 5.6 kg overall, this is very consistent with both oral treatments of Olanzapine for a year or above, as well as with the WellCrush data, the Olanzapine deep intramuscular and long-acting injectables. There are no surprises. It's the same molecules.
Very helpful. Thank you. Perhaps just this last one for me, if I may, for Eric. How might the 749 impact hospitalization rates given the separate UZEDY data that showed cost savings? Thank you.
Eric, are you there?
If Eric can't answer, maybe I jump in again until he comes in. I think we can really learn from the UZEDY data. We know that Olanzapine is highly efficacious, and we know that LAIs really beat all antipsychotics. We've done multiple meta-analyses on that, particularly on relapse prevention and hospitalization. Since hospitalizations are the most costly aspects of care, not only in the United States, but overall, this will lead to cost reductions. I think pharmacotherapy studies will follow and will also show that.
Excellent. Thank you so much, Eric.
Thank you.
Next question, please.
We now turn to Umer Raffat with Evercore ISI. Your line is open. Please go ahead.
Hey, guys. This is Michael DiFiore in for Uma. Thanks so much for taking my question and congrats on the data. Two for me. This is more of a commercial question. How should we think about the peak penetration into the oral Olanzapine segment? As a follow-up to that, you had a slide saying that your total franchise peak revenue was between $1.5 billion and $2 billion. That seems kind of conservative. I just want to get your thoughts on that, especially in light of the fact that, you know, back in the days, I pressed at peak sales were over $5 billion. Thank you.
Thanks for the question, Mike. Chris, do you want to take those?
Sure. Happy to. Thank you for that. I appreciate your optimism. I guess I'll start in reverse order. I think we're trying to be thoughtful about the opportunity, and we realize that for Olanzapine specifically, the opportunity is going to be bigger, at least at the onset in Europe, given that they have higher Olanzapine and higher LAI. I think the bigger thing in the U.S. is kind of the behavior shift to using LAIs and using them sooner in the treatment algorithm to gain that control. To your point about peak penetration, we certainly expect, as Professor Correll said, that the early usage will come from patients that are on oral Olanzapine. You can see the opportunity, and just based on the data, that if patients are not controlled, there could be other oral to Olanzapine LAI use as well as LAI to LAI.
I think we'll have to see how that nets out. We certainly think at start, people are very comfortable with Olanzapine as a molecule, and that's where we will get the initial uptake.
Got it. Maybe if I can speak for the questions.
Thank you.
In the U.S.
Thank you.
We now turn to Matthew Toal with Goldman Sachs.
Sorry, Elliot. Let Mike finish up with his follow-up question. I apologize.
Of course.
Thank you. I appreciate that. Just really, really quick. You said that the U.S. will kind of require like a behavioral change amongst physicians and HCPs in prescribing Olanzapine LAI. I mean, is this going to be a kind of a Herculean effort? I mean, how long do you think it'll take for physicians to kind of realize the value proposition of this medication and really start prescribing it regularly? Thank you.
I don't know that we can set a watch to that necessarily. I didn't mean specifically behavioral change to LAI Olanzapine, just LAIs in general. I think adoption rates, you know, we have less penetration with LAIs. I think that that's just maybe because they haven't had good options. Certainly, we've seen great uptake with UZEDY. If that flows through, I think it could be something similar in that kind of traction. With this, you know, bigger opportunity, as Dr. Correll said, there's a big comfort. People know Olanzapine is a molecule. We haven't been, you know, prolific around stating the curve because we don't know that yet. That will depend on access and reimbursement and all the other things that flow through once you launch. We're very optimistic about this.
As importantly, I think we underscore not only our responsibility in leading this proposition, but also in what it can do for patients from all, you know, lifestyle changes. We described how important and significant it can be in a schizophrenic's life.
Professor Correll, you have anything to add to that?
Yeah, I think I fully agree with that, that in the sense of Olanzapine LAI, there will be a very short runway because we know the medication, we know what an LAI is. If we see that patients on Olanzapine or other LAIs now have this future option, that's an easy sell. What's more problematic, as Chris was saying, is getting overall the LAI use increased over 16%. I think this has happened over time more and more. Having now a new option in terms of a molecule, I think will add to the overall sales of LAIs. Here, Olanzapine LAI will really keep quite a bit of that percentage, and we'll see a steeper increase than even with UZEDY. That's my prediction.
Great. Thank you so much, Professor Correll. Elliot, next question, please.
We now turn to Matthew Toal with Goldman Sachs. Your line is open. Please go ahead.
Great. Thanks. Congrats on the results. Maybe just following up on the peak sales side of the LAI grant side, could you all share any more details on how that breaks down between UZEDY and Olanzapine? It looks like UZEDY peaked consensus sales at around $650 million. How are you thinking about the time to peak sales, as well as the durability of this franchise? Maybe just going a little more specifically into UZEDY, just given the strength of the profile to date, how confident are you in its ability to expand into other molecule classes such as Invega Sustenna? You highlighted that as a key aspect of forward growth.
All right. Chris, I don't know. Were you able to hear Matt's question? I can repeat them for you if you'd like.
Yeah, I think I got most of them. Maybe you can help me out if I don't touch them all.
Okay.
I'll start with UZEDY first and just say, listen, we're really pleased with our results, and we think we've done an excellent job. A big part of that comes from the deep understanding and has penetrated the part of the market in which we directly play, having the majority of that share. I think we're hovering at pretty much maxed out on that. You're exactly right. We will expand into other utilization from other molecules and switches from other orals. That's going to be a big, important part. I think as physicians get more and more experienced with UZEDY, they tend to be more and more comfortable with that. I think composition-wise, overall, for the franchise, Olanzapine LAI will contribute more, particularly because Europe's going to play such a big, important role, having about 30% base oral Olanzapine usage to date and a much higher LAI usage as well.
I think that behavioral change that I was talking about before, a lot of that already exists. Physicians and government bodies, payers have recognized how important it is to the system to get patients controlled and have embraced that. I think we have two really great products, and that combination allows us to hit most of the potential patients. That's a wide swath. 70% 80% of patients could be eligible for either one of these compounds. Time to peak, I don't think we're commenting on yet. That will all flush out when we see uptake and once we know access, both within U.S. and ex-U.S. Chris, did I miss anything?
No. I think those were all the key points, Chris. Thank you. Thanks for the question, Matt.
Next question, please, Elliot.
We now turn to Ash Fermer with UBS. Your line is open. Please go ahead.
Hey, good morning. This is Dee here on Ash's behalf. We have two questions. The first one is that as you are getting ready for the regulatory filing here, I just wanted to see if there's any consideration similar to the UZEDY regulatory review process where I think FDA flagged the instances of patients receiving higher than assigned dose or dually enrolled patients. Are you, I guess, are you confident that Olanzapine LAI data is clean from that standpoint? My second question is, can you talk about which division of the FDA was applicable to go through? As you think about agency adoption, like agency adopting a class label or not, what makes you believe that FDA would be discerning enough in the case of Olanzapine LAI to give you a label that's differentiated? Thank you.
Thanks for the question, Dee. Eric, are you able to answer?
Yes, I'm here. Thank you for the question. I'd start off by saying we learned a lot from the UZEDY filing when we had that CRL, and we had the review and identified the problems you frequently see in schizophrenia trials of dual enrollment. We incorporated that all in our process of executing the Olanzapine study. We had extra monitoring. We had 100% unblinded monitors during the study to make sure that we were giving out the drug appropriately and positively to only a single patient. That's the challenge that you sometimes have in these studies. In addition to extra monitoring and oversight of the study, we did an additional pre-submission inspection on our own to make sure that all the problems we had seen before were not recapitulated in the study. We're really confident in making sure this is a picture-perfect submission.
I'm confident we've addressed all the issues ahead with UZEDY. With regards to the favorability or the willingness of FDA to address this label issue with regards to PDSS, as I mentioned before, we've been in these discussions positively interacting with the idea that if we can generate a database of safety and efficacy that checked a number of the boxes that FDA worked with us on throughout this development program, that is a possibility for what our label will look like. That is still open possibility. I think that the data that we've generated and talked about today supports a very favorable label for this treatment that would give people or patients a new opportunity for treatment. It is the same division that we've worked with on UZEDY, so we're very familiar with them.
Thank you so much.
That includes the totality of the preclinical work as well, demonstrating, as Dr. Eric Hughes would say, the impossibility of PDSS, not just the clinical.
Yeah. It's the totality of the data. As I keep going over, the in vitro data is very supportive of the fact that the formulations are completely different. One dissolves rapidly. It's an intramuscular injection. Ours is a subcutaneous shot that rapidly aggregates in the aqueous environment of the subcutaneous tissue. Our phase I data has shown no spikes in the PK. The totality of subcutaneous injections is almost 4,000 injections. This has fulfilled all the data points that we discussed with FDA. They understand what the submission will look like, and we've had productive discussions on formulating what the submission structure would be, and we're moving forward with that.
Great. Thank you, Eric. Thank you for the question, Dee. Next question, please, Elliot.
We have no further questions, so I'll hand back to you for any closing remarks.
Eric, any closing remarks you'd like to make?
I would like to first thank Professor Christoph Correll for participating in the call today and being the lead investigator for our phase III SOLARIS data and study. We're pleased with the results. I'm proud of the team at Teva for executing a well-run phase III and an entire program, including the great formulation and preclinical work. I think the totality of the data is really exciting, and I think that this will be a great moment to build our franchise in the LAI market for patients with schizophrenia. There will be more to come. Chris, I don't know if you had anything else you wanted to ask and add today.
Thank you all for calling, and thank you for your interest. We really appreciate it. You can tell that we're excited and expect really great things. Thank you for your time.
Great. Thanks, everyone. Thank you to my colleagues. Thank you, Dr. Correll. If you, as Eric mentioned earlier, would like the password for that video, please reach out to Investor Relations, and we can provide that to you. Thank you, everyone. Bye-bye.
Bye-bye.
Ladies and gentlemen, today's call is now concluded. We'd like to thank you for your participation. You may now disconnect your lines.