Hello, and welcome to the joint MorphoSys and Insight Conference Call and Webcast to discuss the FDA approval of Von Juti. At this time, all participants
session.
As a reminder, this conference is being recorded. It's now my pleasure to introduce Anya Palmer, Head of Investor Relations for MorphoSys. Please go ahead, Anya.
Thank you. That is a gentleman. Good afternoon or good morning. My name is Anya Pomerin, and I'm the head of IR at MorphoSys. It is my pleasure to welcome you to this joint MorphoSys and inside conference call and webcast to discuss the FDA approval of Monduvi.
We are speakers from both inside and MorphoSys on today's call. From MorphoSys, we have Jean Paul Cres, CEO Malti Peters, Chief Research And Development Officer and Rola Vandler, Chief Operating Officer. Speakers from inside will be CEO, Helve, Openo, and general manager, North America, Barry Flannery. Also joining for the Q And A session will be Stephen Stein, inside CMO and Cristiana, Stamoulis, Insight CFO as well as Jan Folchstein, MorphoSys' CFO. Mike Booth, Head of IR of Insight, will conduct the Q and A session together with me.
And if needed, one follow-up as this will enable as many of you to ask questions as time allows. Before we begin, I'd like to remind you that some of the statements made by Insight and MorphoSys during the call today are forward looking statements, including statements regarding our expectations for the commercialization of our products, in our development Partners. These forward looking statements are subject to a number of risks and uncertainties and may cause our actual results to differ material, including those described in Insights 10 K MorphoSys 20 F, an annual report, all for the year ended December 31, 2019 and from time to time in other SEC documents of insight in MorphoSys. In addition, I would like to caution everyone that the COVID-nineteen pandemic is an evolving situation and it is still relatively early to be able to assess the full effects of governmental business and social actions and policies and overall economic conditions on our business. Accordingly, it is important to keep in mind that our statements on this webcast speak as of today.
And I now hand over to Jean Paul.
Thank you, Anja. Good morning or good afternoon, everyone. We are all very proud that last Friday, Monjovi received FDA approval as a combination therapy with lenalidomide. The approval provides a new important treatment for adult patients with DLBCL who have progressed as a treatment with first line therapies or later lines of treatment or whose disease has relaxed and who are not eligible for autologous stem cell transplant. This approval is a very important milestone, not only for MorphoSys and inside, but also for the patients battling relapsed or refractory diffuse large B cell lymphoma.
We are very excited with the accelerated approval of Manjovy by the FDA, which we believe emphasizes the high unmet need for patients with relapsed or refractory DLBCL. We have a fantastic opportunity with Monjovi, in combination with lenalidlomide as it is the 1st FDA approved second line therapy for adult patients with RR DLBCL. Over the past months weeks, both our teams for MorphoSys and insights have been working hard to ensure a very well prepared and successful launch and thus to be able to bring this important treatment to market in the United States. For MorphoSys, the approval of Manjovy not only marks an important transformational step into an integrated all our stakeholders. MorphoSys is committed to developing innovative bio pharmaceuticals designed to improve the lives of to thank all my colleagues at MorphoSys who have worked diligently to successfully develop Monjovy.
And to acknowledge the ongoing efforts of the FDA to bring new products to cancer patients. Furthermore, I want to thank all investigators, without home clinical development is not possible. And before I hand over to LV, I want to highlight that And I am convinced that MorphoSys and Insights will continue to work together as we execute the joint commercialization of Mondovy in the U. S. Elvi, please?
Thank you, Ramon. So obviously, I agree that we have a very exciting opportunity here to change the standard of care in 2nd line treatment of DLBCL. In the month, since we signed the collaboration in January, Tafasitamab received priority review for the BLA in February, and we shared exciting new L MIND data at the recent EHA Congress. The approval of Montreal in the US is important for MorphoSys and Insight, but it's only the first step of an ambitious program. We recently announced the submission of Monjovy for the same indication of relapsedrefractory DLBCL in Europe.
And if we view its positive, it could lead to an approval in 2021. In addition, we have ongoing plans to continue to developed tafasitamab in DLBCL and in other B cell malignancies. The Phase III B MIND trial Tafa plus Bendamestin versus Rituxan plus Bendamestin is already underway in patients with relapsed or refractory DLBCL, and we expect to initiate the pivotal program in 1st line DLBCL early next year. For multiple B cell malignancies, The plan to develop Tafar in combination with Pasa Clizib inside PI3 kinase delta inhibitor is also on track and we expect to start that study before the end of 2020. I would like to Mel to walk you through the clinical aspect of Friday's announcement.
Thank you, Herve. First of all, I want to thank the FDA for During the approval process, our dialogue and exchange with the FDA was always very constructive and helpful and the approval now provides a new treatment option for patients with relapsed or refractory DLBCL. DLBCL is the most common type of non Hodgkin's lymphoma in adults worldwide. Approximately 1 in 3 patients initially diagnosed with this aggressive disease, either do not respond to or relapse after treatment with the current standard of care, R CHOP. R CHOP is a combination treatment of rituximab and chemotherapy.
Patients with relapsed or refractory DLBCL who are not eligible for stem cell transplant are poorly served by the current treatment options. And prior to the approval of Mondovy, There was no FDA approved second line therapy to treat patients with relapsedrefractory DLBCL. The unmet need is therefore apparent. Monjovi was granted accelerated approval under priority review with a breakthrough therapy designation based on the phase 2 L MIND study, an open label multicenter single arm trial, which tested monjuv in combination with lenalidomide. Following FDA's approval in the U.
S, Monduvi in combination with lenalidomide is now indicated for the treatment of adult patients with relapsed or refractory use large B cell lymphoma or DLBCL, not otherwise specified, including DLBCL arising from low grade lymphoma and who are not eligible for autologous stem cell transplant. The clinical data in the FDA prescribing information show that in the L MIND study, Monjovi in combination with lenalidomide shows a noticeable objective response rate, a high complete response rate and a long duration of response. Subsequent analysis with longer observation times has recently shown at the Moreover, and importantly, Monduvi was well tolerated in the L MIND trial providing an important treatment option, particularly for patients who are not eligible for or cannot tolerate other forms of treatment. With this, I would now like to hand over to the commercial team starting with Roland.
Thank you, Malte. Let me start by and advocacy organizations and to MorphoSys and inside colleagues around the world who helped us throughout our journey so far. We have a remarkable opportunity with Machuvi and we at MorphoSys and Insight are excited and well prepared to bring this treatment to patients in the United States. Our teams anticipated and prepared for an early FDA approval and have been laser focused on executing a strong Monchoobie U. S.
Launch strategy. We estimate or a DLBCL each year in the U. S. That would be eligible for monjuvie in 2nd or later lines of therapy. Many of these patients have poor prognosis.
And this means our work to launch Manchuvi cannot wait. Manchuvi is the 1st FDA approved therapy for adult patient with second line DLBCL in combination with lenalidomide and it offers noticeable clinical efficacy data and sound in tolerability. And we're excited to bring this much needed therapy to patients. We have worked very closely with our colleagues at Insight, over these past months to lay the foundation for a successful launch through building a strong commercial organization, appropriately interacting with healthcare providers, and preparing for patient access. Over the last several months, we are pleased that our medical teams have conducted extensive outreach to relevant healthcare professionals.
The overall feedback received from these discussions with physicians and lymphoma experts is that Munshovi provides a unique value proposition to meet the continuing unmet need in relapsed or refractory DLBCL. Our commercial organizations are trained and ready. At MorphoSys, we have been fortunate to hire some of the best oncology sales talent in the industry, and our team members have a long track record of deep customer experience and marketplace knowledge within the hematology oncology space. They are now moving to engage healthcare professionals in the U. S.
About Mojuli. For this, during this COVID 19 period, are using a combination of virtual engagement tools to address customer needs and to initiate, maintain and grow connectivity with healthcare providers. We are reaching out to payers starting today to share information on the approval, and we expect coverage will be in line with the labeled indication with access to Machuvi on the government programs, including Medicare Part B, as well as by commercial insurers in the U. S. We are moving on to the last steps of our supply chain, and it will be available through our already established specialty distributor and specialty pharmacy network.
As to pricing, We sought to thoughtfully price Monchoosing by balancing the value of the outcomes and innovation it brings to patients and the health care system with market and saw sizable expectations. The wholesale acquisition cost will average $16,500 per month for the first year of therapy followed by an average of $13,000 per month in subsequent years as a result of a decrease in the required number of doses per cycle. MorphoSys and insights are also dedicated to supporting patients throughout their treatment journeys, and we are committed to help lower patient access barriers. As part this commitment, we have launched a robust patient support program called my mission support. This program offers financial assistance, ongoing education and other want to turn the call to our partner insights whose expertise and established presence in the hematology oncology field will be a key part of the commercial success of Monchule.
Barry, please. Thank you, Roland. It's a pleasure
to be speaking with you today and to share our excitement for the launch of Monduvi in the United States. Our commercial and medical teams are well prepared for the launch and we expect Manjubi to be available commercially shortly. We know from our interactions with hematologists and oncologists that Monduvi represents an important addition to the treatment of patients with relapsed refractory diffuse large B cell lymphoma because their prognosis can be very poor. Driving awareness education of healthcare professionals and patients and providing patient access to Monduvi are the key components to a successful launch and we along with our colleagues at MorphoSys are ready. The collaboration has been fruitful over the past several months And even with restrictions placed on us because of COVID-nineteen, we are fully prepared for the launch.
Incyte and MorphoSys will run largely mirrored commercial and medical teams throughout the U. S. To support Monduvi and both teams are aligned on our priorities. We will focus we will be focused on approximately 11,000 key prescribers across the U. S.
And there is an approximately 80% overlap with Jakafi in this group, so our relationships are already strong. The field teams for Manjovi in include both medical and commercial from both MorphoSys and Insight and will be, equal to approximately 150 people and we believe that's the right size for the target audience. Our ability to leverage Insight's existing relationships and experience with hematology oncology is also very important and perhaps especially so in a mostly virtual environment during the time of COVID-nineteen. We have spent years working with healthcare professionals and we have built trust through developing best in class or 1st in class assets excellent customer service, educational resources, and patient assistance programs as we strive to help improve patients' lives. Our recent launch of Pemazir and continued success with Jakafi are good examples of our ability to thrive in a more virtual environment and we plan to leverage With the team at MorphoSys, we also plan to host an event for investors and analysts later this year.
During this event, which we expect to include expert guests on global development plans for tafasitamab and to provide you with an update of our joint U. S. Commercialization activities. The teams at Insight and MorphoSys have much to achieve over the coming weeks and months as we launch Monduvi, but we are excited by the challenge and by the opportunity to bring another novel therapy to patients in need. With that, I'll turn the call back
Thank you, gentlemen, for taking us through the detailed CFDA approval of Majuhvi and the preparation work for its launch in the U. S. Operator, are we now ready to take
Our first question today is coming from Mark Frum from Cowen and Company. Your line is now live.
Hi, thanks for taking my questions and congratulations on the approval. In the prepared remarks, you mentioned the label being a bit earlier line than many of the other things have been approved recently at relapsedrefractory DLBCL. About how many of those 10,000 new patients per year that you think are eligible for Pluto V. Do you think are not eligible given the labels that the, that your competitors have?
Do you want to take that question?
Miles are taking the question, yeah?
So I think the 10,000 patients we refer to, are based on our assumption of the 2nd line and higher labor. So we believe that the 10,000 patient would provide the patient pool per year or the number of patients per year that would be eligible for the treatment of manjuvie and lenalidomide. So that's based on our current assumption and we believe that the full amount of 10,000 patients would benefit, hopefully from the treatment of our combination therapy.
I guess, when you analyze the market, is, you know, competitors like Pallavi or
CAR T
cells that are kind of approved in the 3rd line or later? Do you guys think all 10,000 are eligible for those therapies, or is it only a much smaller number that is eligible for those 5 or 6 dozen?
This is Jean Paul, Chris. I'll jump in here. We actually plan to give you a better view on these numbers in our upcoming events in the fall However, obviously, it will be about market share and how fast we'll be able to, with our uptake in COVID times But in, in broad terms, it could assume that 10,000 patient is covered by the label, but obviously there will be, there will be a possibilities of market share versus other the other products. Obviously, we think we're very well positioned versus Pol Ivy, as you can imagine, with having the 1st and only second line treatment on the market now. And, you know, I mean, the if you can see the safety and the very manageable aspect of administration of the product makes it a very compelling proposition for our target.
Mark, hi. It's Steven from Insight. Just to try it, maybe
a little bit of color.
If you step right back and you look at the incidence of diffuse large B cell lymphoma in the U. S. To begin with, you're dealing with about 25,000 new patients a year. If you take the 1st line standard of care chemotherapy combination with a CD20 antibody or CHOP, and you assume that occurs approximately half of patients, you end up with about 12,500 patients. And then you take that patient set And you see who then in that line of therapy would be eligible, again, for potentially curative therapy with another high dose therapy regimen in the second line and a stem cell transplant and you eliminate a few thousand patients then.
And then you write within the label at that point. So you're in relapsedrefractory diffuse large B cell lymphoma, not eligible for transplant. And you'll end up then with about 10,000 patient new patient incidents. So that's how we get to that number. This is the only labeled indication now in the United States for second line therapy.
PolyV and CAR T therapies are labeled for 3rd line therapy and are somewhat different population pool. So that's how we estimate or guesstimate that 10,000 number. I hope that's a bit clearer.
Thank you. Our next question today is coming from Craig Suvanish from Goldman Sachs.
Great. Good morning and good afternoon and congratulations on the early approval. I just had maybe two questions. First, Can you give us a sense of, and maybe it's premature, but I'd love to get your thoughts on, what your expectations are for the shape of the launch curve? Obviously getting a second line label where there is no FDA approved second line, treatment is, the great thing, for Mondjuzy, but I was wondering if your expecting whether it's based on the timing of when you'll be able to secure reimbursement, whether you think this is going to be kind of like a a more gradual launch or are you expecting that given that there's nothing out there that potentially this could be a very quick uptake So that's my first question.
And then my second question, if I could is, I'm wondering, how you think of, the competitive landscape in the future. I do believe Roche is running a holistic study which is a phase 3 study for which potential first line use could date and the first line use could come in early 21. I'm just wondering if you have any thoughts around. What do you think that data might look like and how that might impact the shape of the, launch curve for Manjivi? Thank you.
Thanks, Craig, and this is Jean Paul. Thanks for your question. I'll take the first part of the question and Malte will address the second one on the first line. Regarding the launch uptake, obviously, as mentioned earlier, by Steven and Malta, we have a very compelling label. So very very, very confident in the longer term potential of the product and, potentially the leadership aspect of what we can achieve here.
Obviously, we are in a COVID-nineteen era. So we have to be cognizant of what it means for the space. All the patients, for the HCP. And on that, we have to be a bit reasonable here in terms of uptake. And it might be slower than what we could usually expect.
I'll turn the first line.
Yeah, on the first line study, your corrections stating that the polarics data is reading out in 2021. I would not like to give an estimate of what the probability of successes of this study. But of course, we're monitoring the situation very clear. Our labor, which is in 2nd line and higher patient, and our forecast, are in our mind not affected by how the outcome of the Polaris study will be. Of notes.
And Ervie has alluded already to this. We are very pleased on the progress we are making in our own frontline studies. Our first mine study is rolling ahead of our expectations and we plan to initiate our pivotal first line study at the beginning of next year.
Great. If I
could just have one quick follow-up, just on the comments you made about the teams, there'll be separate teams and they'll be, I guess, mirroring each other. Could you just maybe give a little bit more clarity on how the separate teams will work. And I'm just maybe trying to better understand if there are all the marketing materials and the branding. Will they all be, the same or will there be duplicative but separate efforts depending on how each of the companies believe Manjovy should be best marketed?
Thanks.
So I'll start and I'm sure Roland will fill in. But approximately there's approximately 57 territories that are mirrored. 1 insight representative, 1 MorphoSys representative, and they obviously work together and, are planned to go around the territories, separately, at different times being different parts of the territory, for example. As far as the promotional materials, they're all exactly the same. We work together.
We have a team, that is from Insight and MorphoSys, and all of the promotional materials, education materials will be the same.
Okay, helpful. Thank you very much.
Thank you. Our next question today is coming from Tyler Van Buren from Piper Sandler. Your line is now live.
Hey guys, good morning. Good afternoon and congrats on the approval. Can you just discuss perhaps any interactions with the EMA and your confidence and approval in Europe. I guess there's a thought out there that the EMA is taking a stronger stance on uncontrolled studies in areas where they're active competitors. So, for comparators, sorry.
So, just any thought on being able to use the Remind data for potential approval there. Thanks.
Thanks. It's Steven from inside. I'll start off. Malton may want to add something. So we're encouraged far.
We've put the submission in and we've announced that it's been validated by the European Medicines Agency. So the content therein is is reviewable. You're right in a sense, across the board, that single arm studies traditionally have been harder to get approval there. However, again, you know, as we've been pointing out on this call, there's a large unmet medical need here. And it's not a curative setting once you're in relapsedrefractory diffuse large B cell lymphoma that's not eligible for transplantation.
There are differences in labels of some of the competitor drugs in Europe, which may end up impacting the review cycle but we'll use all the data that's available to us that MorphoSys have been generating over the years to try and convince the regulators. And we remain encouraged by what's developed thus far.
Would it be possible just to elaborate on the differences in the labels that could impact the review cycle?
I think the only the obvious ones are lines of therapy. So if you look, for example, poly via the second line label there, There's some use differences in terms of availability and accessibility of CAR T therapies, that may impact some of the regulated regulatory thinking in Europe, but nothing beyond that at the moment.
Stephen, just a quick, addition from my end, you were completely right, fully supported what you said. The reaction so far we received from EMA worth without very encouraging. And with respect to the approvability of an uncontrolled study. Remember, the CAR T cells had also uncontrolled studies also reached also achieved an approval in Europe based on the high met, high unmet medical need, as Stephen pointed out, we are we are quite, optimistic that EMA will look at our data in a very positive way.
Thank you. Our next question today is coming from Jason Butler from JMP Securities. Your line is now live.
Hi, thanks for taking the question and let me add my congrats. I'm just wondering if you could give us some more color on strategies for confirmatory studies, both thinking about the accommodation or the frontline study or other studies that you might be considering that could support, full approval? Thank you.
Thanks for the question, Jason. This is Jean Paul. So the FDA has been very constructive and supportive in the discussions regarding confirmatory trial options. They actually have agreed, on focusing on the synergy of TAFSA plus LAN. Which is very important.
And as a result, we align with FDA on using our first line pivotal trial as a confirmatory trial. With the final report submission by the end of 2025. So I mean, this is as as Malta and commented earlier, we've made great progress with them on the first line design. And details. We'll share with you later in the fall, but, but this is actually a very good outcome.
Very pleased with with what we align on with the FDA for our confirmatory trial here.
Great. And then just a quick follow-up on your pricing assumptions. Just with the cat, specifically around weight, was the, was the average assumption driven by the baseline characteristic in L MIND and any reason that these assumptions could be different in the real world setting?
So maybe on the pricing, on the pricing, I'll ask Hollam to comment.
Yes. Jason, you're right. We have weight based pricing and, our assumptions for the average patient here was for a patient with 70 to 80 kilograms per weight, which would translate into 5 vials per infusion. And this is reflective not only of what we've seen in the trial, but also what we see in the general population out there for these patients with lymphoma.
Next question today is coming from Brian Abrahams from RBC Capital Markets. Your line is now live.
Hi, good morning and good afternoon and congrats on the approval. So some of the feedback we've received in the past is that real world patients with refractory DLBCL can be tougher to treat up in the clinical trial setting. So I'm curious to hear about your approaches to ensuring that physicians select patients appropriately, to optimize, Monjovi's use and outcomes. I'm curious, to what degree the safety and longer duration of use might improve the translitability, for this drug between the trial setting and real world outcomes? And is there any education you might need to do about the preservation of the CAR T option?
Hi, Brian. It's Steven Star. I'll lead off again. Multi may may wanna add, to my comments. So, you know, obviously, when you, when you conduct a clinical trial, you have, inclusion next dilution criteria that impact patients' eligibility.
And in fact, one of the main thinking we always undergo is to try and replicate as much as possible what does occur in the real world. So in terms of tougher to treat, it's a little hard to comment on what you're saying, but I think our clinical trial will, for the most part, replicate what should occur in the real world. And then obviously, positions weigh risk benefit to everything they do. Efficacy first and you've heard and you've seen our label now in terms of the efficacy data and the second line label with the 55 percent response rate, 37 percent CR8 and 21.7 month duration of response data. So they'll weigh that in and then they'll look the tolerability profile as well and which we find very encouraging compared to competitors in terms of other side effects seen like, you know, cytokine release syndrome with CAR Ts, and some other side effects for some of the other therapies.
And they'll weigh that into their therapy choices every single time. So we think that'll dictate the treatment course. The durability data we find very encouraging, not in the label, but in the EHA presentation, you saw updated data with longer follow-up. That we also find very, very encouraging in terms of picking patients for appropriate therapy. In terms of the back party I think you're alluding to biology, you know, does given, CD19 directed therapy change you can then use as therapy thereafter.
We have, and MorphoSys have produced in a very elegant way in CLL thus far looking that does is the receptor retained after therapy, and it's been illustrated that it is, in that listed in and we'll obviously have to generate more data, in diffuse large B cell lymphoma, etcetera, to just make sure that that is indeed the case that then, you know, you can use, for example, CD19 directed car therapies there after after giving TAVR. So that'll be all important in therapy choices, but we think our positioning with the efficacy data, our tolerability profile And in terms of the biology, in terms of looking like the receptors retained, it does position the therapy really, really well at the moment. I don't know if Multi wants to add anything.
No, Steven. Great answer. Nothing to add from my end.
Thanks so much, Steven. Thank you. Our next question today is coming from James Gordon from JPMorgan. Your line is now live.
Hello, James Gordon, JP Morgan. Thanks for taking the question. One question was just competition in second line. So you're going to be the only company with a second approval. So what does your research suggest about prescriber willingness to use 3rd line agents in 2nd line, such as Parelevi or Carti?
Is this an indication where label usage frequently being observed or you think it will be observed? And if I could just squeeze in one of the quick follow-up, which would also be, you had really strong OS data in L MIND, which could be a differentiator, not a big surprise, but that's not on the label right now, but are there any plans to explore trying to get that added at some point in the future?
Sure. Roland will address the first part of the question in multiple second parts.
Yes, James, given the very high unmet need for these patients once they relapse off their first line treatment and the fact that we no other treatment available. Indeed, there is a range of different treatments that are used by physicians and many of off label. This now changes, of course, with the approval that we've just seen for manjubi and for lenalidomide, where we now, for the first time, do have an FDA approved second line options for these patients in high need. And regarding the overall survival data absolutely, that's a very compelling data point. And perhaps I ask Malte to quickly comment on how this will be, use and disseminated in medical education.
Yes, thanks, Roland. So indeed, we are very pleased with the long median overall survival. We are observing in our recent cutoff that we presented this year at, ASCO and meeting over a survivor to remind you is, close to 3 years. We are not sure the over survival will make it into and put into a potentially updated label because, as you know, FDA prefers to randomized studies to include time dependent endpoints, but we would be interested interested in discussing with FDA potentially to include our updated longer duration of response in an updated label. And if you remember, the median duration of response is also close to 3 years in the updated data set.
So this is something that we will certainly entertain. But we have not yet had a chance to discuss this with the agency.
Thank you. Our next question today is coming from Vikram Plogan from Morgan Stanley. Your line is now live.
Hi, thanks for taking my question. So first, a quick one on timelines. Just wanted to clarify, when we could some initial data from the B MIND study? And then secondly, just wanted to see if you could talk a bit more about the design of the intended first line study that you mentioned is going to start early next year. And I know you mentioned that you expect completion here in 2025, but Just wanted to see if you could also comment on kind of, the data point at which we could start to see some initial data here as well.
Okay. Do you wanna take that one?
Yeah, sure. So on the B MIND, we expect to be at the tail end of the study around 23, 24, depending on how enrollment goes enrollment for B MIND or goes quite well. With respect to the frontline study that we were, started beginning of next year. I can only speculate at this moment. Yeah, I can say that we were positively surprised by the enrollment curve that we have observed for the 1st mine study of our phase 1btwo study despite the Corona situation, we are ahead of the enrollment forecast.
And in my interpretation, this shows how great and highly interest is of the scientific community in testing monjovi in combination with lenalidomide in the frontline setting. So I it's impossible for me to look 5 years into the future But today, we have seen much greater support by the hospitals, and physicians than I would have expected.
Thank you. Our next question is coming from Edsero from Guggenheim. Your line is now live.
Hi, everyone. This is Paul on for Esther. Thanks for taking the questions and congrats on the approval. Just a quick one from us. I was wondering if you'd comment on the dialogue you've been having with physicians on diagnosis of agents during the COVID-nineteen pandemic, and whether or not it has changed, if it has, and how you're planning to manage physician interactions during the early days of launch?
Thank you.
Roland, we'll answer your question.
Paul, this is Roland. Our teams are very close to how our customers are interacting with and what we see in the U. S. Is that this differs across the country depending on the local situation. And our teams are making sure that we have the range of options available virtually to make sure that no matter where, health care professional is, that we can appropriately interact and meet the needs the health care professionals for the information they need to actually make the right prescription choice for their patients.
And regarding the, interaction with health professionals, I actually would like to invite Berry to comment because beyond the preparation that we've been doing on the MorphoSys side, for our launch, which is starting end of this week. Barry and team, of course, have been out there, all every month and being very success in their interactions for their solid portfolio.
Yes, Paul. I mean, just going back to our Jakafi experience, just to you know, see how we've been performing during the COVID, period. We do know that, patients in general for, cancer patients in general the new patient visits dropped off for all drugs, in April May and started to come back in June. So our interactions have been very successful for, Jakafi, because we have such deep experience with these offices and hospitals that we're able to virtually, get in, provide educational material and so forth. For all of these physicians.
And our experience with Pemozir is actually, very, has it is very relatable to the launch of, manjubi because, we know that oncologists, hematologists want to hear about new drugs. And they really wanted to hear about PEMAZIR, and that allowed us to, reach them virtually video conferences speaker programs and so forth. And I know that will occur as well, with one Juvy as we get out there, and start talking to them. Got it. Thanks.
Thank you. Our next question is coming from Evan Seagerman from Credit Suisse. Your line is now live.
Hi, all. Thank you so much for taking my question and really congrats on the rapid approval. So one housekeeping question. With this approval, I assume there is a milestone payment from Insight to MorphoSys. Can you provide any color on the size of that and higher level?
So with no real consensus for kind of guidelines for the 2nd line setting, how important is it for? I'm wondering if we could get on the guidelines or to really kind of establish these guidelines either in the U. S. Or Europe to help solidify the launch. Thank you so much.
Well, I'll answer the second question. First, just in terms of guidelines, actually the most important one in the United States is NCCN guidelines. MorphoSys together with, Insight has already submitted our request to be added to the guidelines for, treatment of patients with diffuse large B cell lymphoma. Other compendia, will be, updated as well. But the NCCN is already in.
We think that there'll be a rapid addition to the guidelines for diffuse large B cell lymphoma as other drugs have been added very quickly that have been approved recently.
In terms of your first question on the milestones, in general, we have not disclosed the breakdown of the milestones. However, regarding this particular event, given that the FDA decision was expected to come soon after the signing of the deal. We had incorporated this event in the upfront payment. So there won't be an additional milestone.
Thank you for
the color there. Appreciate it.
Thank you. Our next question today is coming from Daniel Wendorf from Commerce Bank. Your line is now live.
Yes. Good afternoon, and thanks for taking my questions. My main question would really be, can you remind me on the key marketing message for Manjovy again? And in particular, can you use the shown PFS and OS benefits as well as the REMIND data to market the drug? And then also a house housekeeping item, just to to see whether I I got this right.
And the con confirmatory trial for for the approval, will this be the first line trial you have on the way and which will begin in early next year? Thank you.
Daniel, thanks for your question. This is Jean Paul. I'll quickly answer the second part and Roland will address your message in question. The confirmatory trial will be the pivotal first line trial to start early next year. Hola for the messaging?
Yes, Jean Paul. Our messaging is straightforward for 2nd line patients with, relapsedrefractory DLBCLs that are not eligible for autologous stem cell transplants, monjouvealidomide provides the deep response and the durable response that you have been looking for all with a safety profile that is sound and tolerability that is sound and an accessibility that, lets you use this targeted CD19 therapy in your practice, no matter whether in academic setting or in a community setting.
Thank you. Our next question today is coming from Michael Schmidt from Guggenheim. Your line is now live.
Hey guys. Thanks for taking my questions and congrats on the approval. Two questions from me. Around the Phase 1b study in frontline DLBCL, I was just wondering how we should think about the efficacy bar in 1st line patients and what type of result in the phase 1b study would increase your confidence in the outcome of the plan 1st line, phase 3 trial. And the second question, for the inside team was just on the U.
S. Profit share calculation. I was wondering if you could help us with some additional guidance on, the marketing, SG and A allocation to the joint venture. I think you mentioned 150 sales reps in total. I'm just wondering if I think about this correctly and what added marketing expense might be allocated to the JV?
Thank you.
Walter, can you take the first part of the question, the safety and efficacy of first mind and Cristiano, the second piece. Thanks.
Yes. So the first MIND study was not designed to look at the efficacy comparison between standard of care R CHOP versus R CHOP plus monjovi lenalidomide. It is a safety study with a total of 60 patients. As I said, I think this week or so, we expect completion enrollment and we have, of course, monitored very closely the safety signals and are very happy and content to say that so far nothing unexpected, emerged in this study. So we believe that we a high chance to start our pivotal frontline study as planned.
That's, that's maybe all I can say at this moment.
Hi, Michael, it's Cristiano. Regarding your second question, this is a fiftyfifty profit share. So everything is split fiftyfifty between the two companies. So in terms of the SG And A or sales and marketing costs, both FTE related cost as well as external cost, marketing support and other will be split fifty-fifty between the two companies.
And just to clarify, Michael, it's not a 150 sales reps total between the two companies. It's about 150 field based people, and that includes medical affairs, our MSLs, our oncology clinical nurse educators, and market access people.
Understood. Thanks so much.
Thank you. Our next question today is coming from Suzanne Von Vortschhuizen from Kempen. Your line is now live.
Just one with regards to the development in 1st line. You plan to start a Phase III early next year and the plan has been there for longer, but I was just wondering if there anything that you've seen so far in terms of signals from from the first mind trial, whether that's set into the decision to start that study and design, like, sample size and such. And basically, what should we expect for Q4 data release from the phase 1 study will it be on all patients? What type of data will you report?
So, 1st of all, again, we are extremely encouraged by the fast enrollment and recruitment in this study. If you see something like this, it's typically a sign that the investigator community is really excited about a treatment or potential new opportunity here. Again, the study was not designed to make any preliminary conclusions regarding efficacy. But we designed the study to generate a robust safety signal in order to ensure that the bigger frontline study that will be the pivotal study will be conducted in a safe manner and will be predictable in terms of safety signals. So again, so far we have not observed any unexpected safety signal, which is really encouraging for us.
That's all.
And maybe just to follow-up because for the Q4, data release on the Phase 130 what should we expect there?
I'm not sure when we will be able to share the data. It depends a little bit on how fast we are with the analysis phase. I doubt it will be in Q for, but we are doing the best we can to analyze the data as quickly as possible and we'll share the data as soon as we have a robust data said.
All right. Thanks a lot.
Thank you. Our next question today is coming from Mara Goldstein from Mizuho. Your line is now live.
Curious as to what or rather which treatment, do you think will pose the most significant challenge to displace as you begin you roll out Montruvie. And secondarily, you mentioned that Montruvie will launch shortly. Can you discuss what are the rate limiting steps that need to occur ahead of product availability? Thank you.
So
the most significant challenge we know is Barry, sorry for me to say. Is the most used in the second line setting is Rituxan and a various chemotherapy combinations, even though there's no approval there, that's used. And, the data from these, various studies in the second line setting with these chemo combinations like Rituxan and Gemox, for example, is variable. And in fact, it looks like the, duration of response, where manjubi does really well, the duration of response for these Rituxan chemotherapy combinations looks to be much less. So that's where our advantage is.
And, it Roland might be able to give more information, but I think the, manjubi will be available by the end of this week.
Okay. Thank you.
Our next question today is coming from Matt Phipps from William Blair. Your line is now live.
Hi, thanks for taking my questions and congrats on the broad label. One of you could provide your latest thoughts for the 1st line trial around either enrollment criteria or maybe endpoint hierarchy. So they're thinking about cell of origin or risk status given the results they're about robust trial with lenalidomide. And also, are you considering using baseline in case in case sales as a biomarker in this trial?
Sir, could you take that one?
So, with respect to the enrollment criteria, we use, standard enrollment criteria with respect to the definition of untreated, DLBCL patients We have focused on those patients with a bad prognosis in terms of IPI score. So we want to enroll those patients that have a IPI score of 3, 4 or 5. And we believe that based on the data that emerged last year with respect to the robust study, the ECOC 1412 study, the potential efficacy for the combination of Von Jovi and lenalidomide in this patient population may be quite significant. And of course, we will continue to enroll the same patient population in our pivotal study compared to the ones that are currently being enrolled in our frontline
Thank you. Ladies and gentlemen, we have time for one more question and that is coming from the line of Stephen Willey from Stifel. Your line is now live.
Yes, good morning. Thanks for taking the questions and congrats on the approval. Just a quick question. So, noticed that there is a bit of a discrepancy just between the updated EHA data set and the label data set. It looks like the label excludes around 9 patients.
I think 7 of those patients would see our patients. Is this just a byproduct of FDA requiring a centralized DLBCL diagnosis. And I guess how, if at all, do you know, this might impact the updated DLR data that was presented Thank you.
Yes. Hi, Stephen. It's Stephen from Insight. You're exactly right. So the FDA in treated the centrally confirmed diffuse large B cell lymphoma population in terms of labeling.
And that's how they ended up with their patient number compared to what been presented in prior presentations. It's as simple as that.
Got it. Very helpful. Thank you.
Thanks. Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Anja for any further or closing comments.
Thank you. Ladies and gentlemen, this concludes today's conference call. The Investor Relations teams of both inside and MorphoSys. We will be available for additional questions. And for now, we thank you for joining the call.
Have a good day. And bye bye.
Thank you. That does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.