Thank you very much. Thank you, and welcome to this press conference where we're going to present the strategic partnership we have currently announced today with Zentiva for the commercialization and manufacturing of linaprazan glurate in Europe. This is, as you understand, a very important step, milestone for us, and marks a significant inflection point for Cinclus Pharma as a company, but specifically for linaprazan glurate, which is definitely its validation. This is a very good validation for the substance, and we are proud to actually announce that today. Also, this alliance covers everything necessary that's needed to bring linaprazan glurate successfully to the market across entire Europe, which I also think is important. I mean, we are, as a team now, as a partnership together, we benefit from, actually, I would say, world-leading expertise in both gastroenterology-focused development, R&D. We have regulatory affairs.
We have good manufacturing formulation knowledge. Last but not least, commercialization power, including price and reimbursement expertise as well, which is, of course, needed in Europe. I mean, this collaboration and partnership definitely maximize the likelihood of a very successful development, both commercially and as well as development in Europe. I also think it's also important to mention that this also gives us or gives us an indication of what captures significant global value, specifically in the U.S., where we still have, of course, the rights, the commercial rights. This gives us a good view on how a deal structure could look like in the U.S. after the readout of the phase III trials. We need to have in mind that the U.S. market is significantly bigger than the European-wise, especially from a price point of view.
This is interesting also from validation also from that perspective. Looking to the figures in this deal, the total deal value is up to EUR 220 million, so almost SEK 2.5 billion. That is divided into both development, regulatory, and commercial milestones that will be. The first upfront payment is EUR 13 million or SEK 143 million. Then we have also a near-term milestone expected in 2026. On top of this, we have tiered royalties on the European net sales, which are starting up from the high teens and exceeding 20% at the top sales tier. That is also a very, very positive royalty amount. That will be starting from the first sales. As you understand, this is a European deal. All the commercial rights outside Europe are still in our hands.
I can also mention that this deal is during at least 10 years and during the time of exclusivity of the product, the longest period when we have the exclusivity, either in the regulatory exclusivity or within the patent exclusivity. It will be at least 10 years or more. Just some wording about Zentiva, which I think is important also to mention. Zentiva is a company, formerly a part of Sanofi, but they were divested in 2018 to Advent International, a U.S.-based and one of the world's largest private equity firms. They have a very, very strong background and a strong ownership. It's also recognized that it's a growing portfolio of established, and actually, they started up as a generic company, but now they put a lot of effort and investment into innovative treatment and into specialty pharma, especially also specializing in gastrotherapeutic areas as well.
This is a key sector for them, and they really are committed to invest in this. They also have a very strong commercial footprint across Europe in all European markets and with very good proven capabilities. They also have good formulation development, production, manufacturing, and good distribution from their own R&D centers, but also from their own state-of-the-art manufacturing sites in Europe and in India. As I mentioned, Zentiva is now making significant investment in innovation and the pipeline expansion. It's transformed into, I mean, the wish is to, and also the ambition is to transform the company into a leading specialty pharma company, focusing to deliver differentiated and high-quality medicines also within unmet medical needs. Also interesting to see that they have a very, very strong focus in Europe. Europe is the key market where they want to grow.
If you just look into a small overview on Zentiva, it's a very old, well-renowned company. As you see, established in 1488 in Prague. As I said, they have been acquired by Sanofi, but also now carried out to Advent. An old established company. They have very much of a pan-European platform. Good sales and good EBITDA, very good annual organic growth, both in sales and in EBITDA on 10+%. They have, as you understand, a good portfolio of different products and not dependent on only one product here. That's also important from a solid, so they are solid in their incomes for the future and what they can invest. They have more than 5,000 employees, whereof almost 50% of these are commercial FTEs. All these commercials are in Europe. They have representation in all European countries.
R&D centers I already mentioned and also their manufacturing sites. Of course, they also will. Their linaprazan glurate in their sites in Europe, as well as the API or the drug substance will be produced in India in the state-of-the-art site there. As you understand, they also have a highly experienced management team, and they are very much committed now to prepare and to later on launch this product. This will be a key event also for Zentiva. Before opening up for Q&As, I can just repeat some of the advantages with linaprazan glurate from a European point of view. I think that normally when we have discussed this, we have always discussed it maybe from a global point of view and specifically from a U.S. point of view.
I would say that the differentiation factors and our target population that we are now focusing on, on the severe patients and have the aim to deliver a superior treatment versus the standard of treatment today in this niche population is key for success specifically in Europe. That we can deliver the best-in-class acid control, delivering the best-in-class healing in the severe patient population and best-in-class symptom relief, that is, of course, a very, very good position to have going further with the launch and the price and reimbursement in Europe. If you look at the funnel, the patient target population here, we are aligned with Zentiva regarding this strategy where we are focusing on the severe GERD patients and also patients that are unhealed after PPI treatments. You know that approximately 10% of the milder patients are unhealed after PPI treatments.
More than 30% of the moderate patients are unhealed after PPI treatment, and more than 50% of the severe patients are unhealed after PPI treatment. This is a very interesting target group together with the entire severe patient population. Also, remember here, symptom relief is also important for the European market. Here we know that 50% of patients suffering from night-time symptoms and definitely affected by the quality of life, that is something that we will also focus quite a lot on in our future studies. Talking about studies, as you know, we will be starting up our first patient in the first phase III now in Q3 this year. This, as you can see, is a very high focus on the European markets and the European sites.
This is also a good platform to start from launching a product in Europe as well, to have so many sites already experience this. I think it's worth mentioning here that the phase II trial delivered 93% healing in the best cohort of the severe patients compared to less than 40% in the PPI group. In fact, we also delivered 100% healing of the partial responders after eight weeks of treatment with PPIs. That is also a very important step and showing the efficacy of this substance. I think also it's worth mentioning in Europe, we might be the first PCAB, not only the best in class. We have the possibility to be first in class. This is obviously the first PCAB deal in Europe ever. This is also an important milestone for us.
With that said, I think I stop there and open up for questions.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Ludvig Svensson from DNB Carnegie. Please go ahead.
Yeah, thank you for taking my question and congrats on the deal. My first question, what does Zentiva reach look like in the primary care in the specialist setting? What makes them a strong partner specifically within GI?
As I mentioned, I mean, they are transforming the company going from a generic company to be a specialty pharma company. One of their therapeutic areas that they will invest heavily in is gastroenterology.
They have currently 800 FTE within commercials across Europe, and they have presence in all European markets except for a few countries where they have a distributor. What you could say here is that, of course, they will, with that number of sales reps and sales commercial people, they also have a focus. They also can reach, of course, the gastroenterologists, which is their main focus when going into innovative products, but also they have the capacity to reach primary care as well. Even though, remember, I mean, our focus is the severe patients, and they are mainly treated by specialists. I think also important here to, as a company here, this launch is, of course, very important for us, Cinclus Pharma, but it, I mean, is also very important for Zentiva. This is not just another product for them. This is a key product.
It will be a focus product for them. This is exactly a strategic fit for them to initiate their journey to become a specialty pharma company.
Okay, thank you for a great answer. Do you aim to establish more partnerships before the top line in 2026?
As I mentioned, I mean, this gives us, I think firstly, I mean, we have communicated to the U.S., we want to buy ourselves optionalities in the U.S. We do not want to, I mean, we want to wait with the US decision after the readout, at least of the first trial, phase III trial. We get in value inflection point. That is now when with the European deal, we also have, I mean, giving us more options. Actually, there are, of course, some few Swedish companies that have actually launched themselves in specialty pharma.
I mean, the latest example was Caliditas. They did it fantastic. What you, I mean, of course, in this case, since we are working on a specialty pharma strategy, this could actually be a position. Also, that gives us a strong negotiation hand with potential partners as well in the future. I think U.S., we are postponing that, but we will, of course, have ongoing discussions. In the rest of the world, I think also this could be a trigger, this deal could trigger other discussions that we already have, but also the increased interest. We have interesting market in the Middle East, South America. We also see interesting progress in Asia, in Japan, in South Korea, where this also could trigger other deals.
Whether they will be before or after the phase III is too early to say, but definitely this is something that we will work more intense, I mean, we will intensify our work on this.
All right, great. That was all for me, and congrats again.
Thank you. Other questions?
As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Alexander Kramer from ABGSC. Please go ahead.
Yes, good morning. First of all, congrats on the nice deal. And I have a question on the clinical development path for linaprazan glurate. So now with this deal in the hand, your plan was initially, of course, when you did IPO last year to run these two phase III studies, of course, that you need as required by the regulatory authorities.
My question is if this deal could potentially accelerate your clinical development path for linaprazan glurate when it comes to sequencing the first phase III study versus the second phase III study, and also when it comes to the top line data readout for the healing data that you expect next year. Thanks.
Thank you, Alexander. Thank you. Good question. Definitely, this is something that you know that we are working all the time to accelerate, to do everything that's possible to accelerate the development plan. This, of course, could be a trigger for that. I mean, it's still too early to say anything about that. I would definitely say that this opened up. It is, and we will investigate it further.
I think, although I think it's also important to mention that, I mean, we're starting up the first phase III trial now, and we will do everything that it takes to speed up that as fast as possible. This gives us, of course, also better margin to do that. It gives us also less, reduced the financial risk of the case overall. That gives us also opportunities at looking into new possibilities to speed up things. It's too early to say anything about that, but that is definitely something on our agenda as well.
All right. Thank you very much. That's it from my part.
There are no more phone questions at this time. I hand the conference back to the speakers for any written questions or closing comments.
Okay, thank you very much.
I think this is a very important milestone for us as a company. We're taking step by step in direction to get an approval of this linaprazan glurate drug that will meet the unmet medical need within this disease. You know where to reach me if there are further questions. I'm happy to answer them whenever you want. Let's stay in touch and thank you and have a nice day.