Ahead of infectious disease event with GSK management. As usual, the presentations were emailed to our distribution list earlier today and is available on gsk.com. Please turn to slide 2. This is the usual safe harbor statement, we'll now move to the next slide. Today's speakers are Emma Walmsley, Tony Wood, Luke Miels, and Deborah Waterhouse, and leaders across our R&D commercial organizations, who will join us for one of our 4 breakout sessions a little bit later. On this slide, you'll see today's presentation is going to be hosted by Emma. We'll be joined by Tony and Luke, and this presentation will last for about 30 minutes, followed by 4 mini 30-minute breakout sessions, including Q&A. We'll run each of these breakout sessions twice so that participants can attend two of their choosing.
We'll then return for a final Q&A session with Tony, Luke, and Deborah, and the broader team before closing. After the event, all presentations and materials will be available on demand on gsk.com. Turning to slide five, I'll now hand the call over to Emma.
Thanks very much, Mick, and a really warm welcome to everyone. Please turn to slide 6. GSK is a focused global biopharma company with strong momentum and big ambitions to get ahead of disease by uniting the best of science, technology, and talent. We have a unique strategy focused on prevention as well as treatment, with an exciting portfolio and pipeline across 4 therapeutic areas based on our deep understanding of the science of the immune system and advanced technologies. We are committed to delivering our competitive medium-term sales and profit outlooks, and are confident in our ability to sustain profitable growth through the decade and beyond to deliver human health impact at serious scale. Today, we're hosting the first of a series of Meet the Management events. This session will focus on our progress, capabilities, and growth prospects as a world leader in infectious diseases.
You'll also have a chance to meet some of our impressive R&D and commercial talent during the breakouts this afternoon. Next slide, please. For more than 70 years, GSK has pioneered in infectious disease innovation. Our infectious disease portfolio is the broadest in the industry and represents two-thirds of our pipeline. In 2022, sales from infectious diseases, including HIV and pandemic solutions, amounted to nearly GBP 16 billion, over half of GSK's total sales, and we expect this therapy area to be a major source of future sales and profit growth. Our vaccines business is a key driver of this, and our innovation in shingles, meningitis, and pediatrics is unparalleled. We're now adding to this, following the ACIP recommendation last week, with the launch of the world's first approved RSV vaccine for older adults, our latest innovation, Arexvy.
With the launch of this vaccine, GSK will be the world's leading biopharma company for adult immunizations. As you'll see today, we have further substantial innovation in clinical development, with new vaccines and medicines for seasonal respiratory infections, bacterial, fungal, and chronic viral infections. You'll also hear about our plans to continue leading in global health and in the fight against antimicrobial resistance. All of these are areas of high medical need, and GSK is needed. Infectious diseases remain a significant societal burden, responsible for one in six deaths globally. Governments and healthcare systems increasingly recognize this, now placing increasing value and focus on early intervention through vaccination and, of course, effective treatment. Getting ahead of disease is better for patients and society, and we are very much committed to it.
Of the more than 2.5 billion people we will reach this decade, the significant majority will be through our infectious disease portfolio, and it is equally financially attractive. The market for infectious diseases is expected to exceed GBP 100 billion by 2028. With a world-class pipeline and portfolio underpinned by proven technical expertise in manufacturing, regulatory, and commercialization, we're confident that GSK will deliver competitive, profitable growth in infectious diseases through this decade and beyond. I'm now going to hand over to Tony, who's going to highlight our R&D focus here and his priorities, including the high unmet medical need associated with infectious disease. Slide 8, please.
Thank you, Emma. Welcome everyone. Please turn to slide 9. We have an exciting portfolio of 69 assets in clinical development, with a focus on prevention and treatment in our 4 core therapeutic areas, shaped by the sciences immune system, advanced technologies, and outstanding people. The combination of which helps us to get ahead of disease. We're confident that this pipeline will strongly offset the loss of exclusivity from dolutegravir at the end of the decade, enabling GSK to deliver competitive, profitable growth to 2026 and beyond. Please turn to slide 10. When I took on the role of chief scientific officer in August last year, I set 3 clear priorities. 1, a focus on execution and acceleration, which will increase our vaccines and specialty medicines pipeline. 2, doubling down on technology to deliver innovation better and faster.
3, to build a culture that is ambitious for patients and where talented people thrive. Please turn to slide 11. With this framework established, the increase in infection is a major concern for patients and society. To illustrate this, you will see on the slide that approximately 1 billion people are affected annually by seasonal respiratory viruses such as RSV, influenza, and COVID, and many require hospitalization. Millions of individuals are also struggling with bacterial and fungal infections, while hundreds of millions live with chronic viral conditions like hepatitis B. Our objective is to revolutionize the prevention and treatment of infection, to enhance the quality of life of billions globally, representing a significant market opportunity. Please go to slide 12. We have a rich tradition of innovation leadership in infectious diseases.
We've been at the forefront of developing novel science and technologies that safeguard people from diseases caused by bacteria, viruses, and parasites. Over the past two decades, we've introduced over 15 new vaccines and medicines. We expect to have 22 data readouts and 25 launches by 2031. Later this afternoon, you'll hear from some of my R&D colleagues about how we address the challenges of seasonal respiratory viruses, bacterial, fungal, and chronic viral infections. Importantly, you'll also hear from Deborah Waterhouse about delivering health and impact at scale, and how GBP 1 billion allocated over 10 years will accelerate research and development to prevent infectious diseases that disproportionately impact lower-income countries. Next slide, please. 44 of the 69 assets in our portfolio tackle infectious diseases.
Among the mid to late-stage development opportunities, we have several potential first or best-in-class vaccine candidates, which address high unmet medical need and have an attractive commercial potential. Our vaccines franchise is getting even stronger, thanks to the great success of Shingrix. On the right-hand side of the slide, you'll see some recent pipeline developments. The first one listed is Arexvy. We have a huge opportunity with Arexvy, our RSV vaccine, the world's first approved vaccine for older adults. Our goal is to become the leader in RSV with our exceptional data, and last week at ACIP, we presented second season data, which showed Arexvy continues to provide efficacy against low respiratory tract infection and severe disease over two full RSV seasons.
We're on track to be the first vaccine to have data in adults aged 50 to 59 in second half of 2023, which will provide additional information about the vaccine's efficacy and safety. A next example is an invasive meningococcal disease, which is an uncommon but serious infection, which can cause life-threatening complications and death. 5 serogroups are responsible for most meningococcal infections, and no single approved vaccine can protect against all 5 of these. MenABCWY could provide the broadest coverage against the most prevalent serogroups, leading to a simplified immunization schedule and increased vaccine uptake. We're working closely with regulatory agencies to review the complete phase 3 data before U.S. regulatory submission in 2024. Antimicrobial resistance proposes a significant danger to global health and the well-being of many individuals.
It causes over 1 million deaths yearly and is projected to increase to 10 million by 2050. In the U.S., there are about 15 million uncomplicated urinary tract infection episodes each year, with approximately a quarter of these being resistant to current treatments. A third example in our portfolio is gepotidacintidacintidacintidacin, which has the potential to be the first oral antibiotic for uncomplicated urinary tract infections in over 20 years. The U.S. FDA has granted gepotidacintidacintidacintidacin qualified infectious disease product designation for uncomplicated urinary tract infection and urogenital gonorrhea, with the latter also receiving Fast Track designation. You may recall that EAGLE-2 and EAGLE-3 phase III trials were stopped early for efficacy, following a pre-planned interim analysis. The data were recently presented at ECCMID.
An oral antibiotic for uncomplicated urinary tract infections has not been approved by the FDA in over 20 years, so we're working with them on the totality of the information that is needed for a thorough review. To complement our UTI portfolio and gepotidacintidacintidacintidacin, we added Tebipenem, an oral carbapenem, a novel late-stage antibiotic for complicated urinary tract infections. If approved, Tebipenem will address a high unmet medical need caused by rising levels of antibiotic resistance. The U.S. FDA has also granted Tebipenem qualified infectious disease product and Fast Track designations, and additional phase 3 trials to support the regulatory submission are ongoing. We also recently obtained rights to Brexafemme, a unique antifungal treatment that inhibits oral group glucan synthesis and is the first of its kind. This medication has been approved for the treatment of vulvovaginal candidiasis.
With the growing concern of invasive candidiasis and resistance to fungal pathogens, Brexafemme is a valuable addition to our portfolio of anti-infective therapies. It addresses a critical medical need, especially for patients in ICU hospitals with underlying health issues. What's coming next? Let's turn to the next slide to highlight some interesting opportunities. We are committed to delivering the next wave of vaccines to address infectious disease, and this slide highlights two first or best-in-class opportunities in phase 1 or phase 2 clinical development in the coming years. GSK3943104 is a recombinant protein that is enhanced with an adjuvant for herpes simplex virus. Around 500 million people across the world are infected with herpes simplex virus or HSV. One-third of patients with genital herpes suffer frequent outbreaks.
Beyond the physical outbreaks, genital herpes is also associated with significant psychological morbidity, stigma, low quality of life, and a threefold increase in the risk of acquiring HIV. GSK413 is in clinical development to prevent Neisseria gonorrhoeae infections in individuals aged 16 years and older, regardless of previous infection history. It's a very common sexually transmitted infectious disease, with more than half of cases occurring among young people aged 15 to 24. Untreated gonorrhoeae can cause serious and permanent health problems and can increase the risk of getting and transmitting HIV in both women and men. This asset has been granted Fast Track designation by the US FDA, underlying the pressing medical need for this vaccine. Please turn to slide 15. My second priority is doubling down on technology to deliver innovation better and faster.
We have a leading suite of platform technologies which will advance our infectious disease pipeline, unlock potential, and go beyond existing modalities. Our focus is to deliver results from this platform. Our adjuvant platform is a particular area of strength for GSK. We're applying the AS01 adjuvant used in Shingrix in several pipeline opportunities, including Arexvy, our RSV vaccine for older adults. The second key platform is mRNA, where we are pursuing advances through our collaboration with CureVac and increasing our internal capabilities. CureVac is developing a second-generation mRNA backbone. Illustrating this, we've received promising Phase 1 results for modified monovalent mRNA vaccine candidates that target COVID-19 and flu. Our next step is testing these in multivalent format. We're currently developing a next-generation multivalent flu vaccine that can protect against multiple influenza strains. Phase 1/2 trials are underway, and we're encouraged by what we've seen so far.
We anticipate having the multivalent data by the end of 2023. A third key platform was acquired through the acquisition of Affinivax. The Multiple Antigen Presenting System supports higher valency than conventional conjugation technologies, potentially enabling broader coverage against prevalent pneumococcal serotypes. It introduces an additional form of immunity, specifically T-cell-mediated, disease-specific anti-protein immunity, complementing the disease-specific anti-polysaccharide immunity. This allows us to develop multivalent vaccines for complex bacterial infections. A first example is our next generation 24-valent pneumococcal vaccine candidate. That's in phase 2 development and utilizes this highly innovative MAPS platform technology. It's designed to prevent invasive disease and pneumonia in children aged 6 to 17 years and in adults of 50 years and older.
Our aim is to be the first to market with a 24-valent vaccine, which is currently in phase II development, and we plan to start the phase III program in 2024. The 30-plus valent vaccine is anticipated to extend coverage to more than 90% of all serotypes currently in preclinical development, and we plan to advance it into the clinic in 2024. We're also diversifying into RNA oligonucleotides, a promising technology platform. We're excited to explore the potential of our antisense oligonucleotide, bepirovirsen, as the first functional cure for chronic hepatitis B. Bepirovirsen or bepi, has a unique triple mechanism of action. It inhibits viral replication, reducing viral DNA and thus the production of viral proteins, including the hepatitis B surface antigen. Importantly, it stimulates the body's innate immune system.
We believe this triple mechanism of action is the reason for bepi's unique profile as potentially the first clinically meaningful functional cure for hepatitis B. Please turn to slide 16. The use of data technology is revolutionizing the field of human biological science. Through advances in genetics, functional genomics, AI, ML, and real-world evidence, we can now improve targeting, patient choice, clinical trial design, and recruitment. Our collaboration with industry leaders provides us access to some of the richest and largest data sets available, which enables us to improve target validation and translation. Our partnership with Tempus, for instance, has given us access to one of the world's largest sources of de-identified patient data, accelerating drug discovery, and we also collaborate with the UK Biobank.
Data technology is critical to the future of drug discovery, empowering scientists to interact with and interrogate rich, proprietary biology, chemistry, and clinical data sets efficiently. Our world-leading AI function vertically integrates with our laboratory sciences and clinical research and development organizations. Machine learning has proven to be a valuable tool in characterizing disease and accelerating the discovery of novel medicines. Our research with bepi is a prime example of how machine learning can generate deep insights. Our algorithms identify patient profiles indicative of clinical and biological trajectories and predict future responses to bepi. This has led us to uncover five distinct patient subtypes in response to treatment, almost doubling our patient response prediction compared to traditional virological markers such as the HB surface antigen.
We've since published positive B-Clear phase 2b results for bepi, with the B-Together phase 2 data expected later this year. The combination of these technologies allows us to better predict the future outcome of our treatments, starting with bepi phase 3 trials, where we're targeting a functional cure response rate of 20%. Please turn to slide 17. I firmly believe the convergence of science and technology is key to transforming medical discovery. Our investment in platform and data technology has resulted in encouraging improvements in pipeline productivity, leading to the discovery of new treatments. Since 2016, our end-to-end cycle times have improved by 20% or 3.7 years compared to median industry benchmarks. In phase 2, our probability of success has improved by 10 percentage points since 2016, bringing us in line with the industry median of 26%.
At the same time, our success rate in phase III and registration remain upper quartile, driven by recent vaccine successes. Despite the sector's lengthening cycle times, our consistent performance improvement has led us to surpass the industry average in bringing innovation to the market. We're now competitive and reached this goal in 9.6 years, compared to the industry average of 11.4 years. All of this is only possible with our scientists and partners. We have considerable existing expertise and a strong, diverse talent pipeline that is building future capability. Creating an ambitious culture for patients, investing in our teams, and disciplined capital allocation will give us the greatest potential to raise the bar for patients. I'll now hand it over to Luke. Please turn to slide 18.
Thanks, Tony, and hello, everyone. Thanks for joining us. Please turn to slide 19. You can see on this slide that we have the broadest infectious disease portfolio in the industry, with double-digit growth. Our infectious disease sales in 2022 reached an impressive GBP 16 billion, more than half of GSK sales. From 2016 to 2022, we've delivered a 12% CAGR across our infectious diseases portfolio, with our core growth drivers, HIV, meningitis, and shingles, delivering GBP 10.5 billion in sales in 2022, with double-digit compound growth and high margins. Please turn to slide 20. The infectious disease market is expected to grow to more than GBP 100 billion by 2028 on this slide. There's significant unmet medical needs and growth opportunities across respiratory viruses, bacterial, fungal, and of course, chronic infections.
We're already leading in several segments. As you heard from Tony, there are several first-in-class and best-in-class opportunities in clinical development that will enable us to compete in attractive markets like pneumococcal. Please turn to the next slide, which is 21. Our industry-leading experience, commercial capabilities, and execution in multiple categories such as shingles, meningitis, and pediatrics, has enabled us to deliver competitive launches and drive mid-life cycle product growth. We've improved the effectiveness of our sales force across key markets, including China, and used our commercial capabilities and disease area synergies across our operations whilst deploying digital and predictive analytics to enhance commercial results. For example, Shingrix has shown 5 consecutive quarters of growth, including record sales last year, with increasing contributions across all geographies, and is now available in 31 countries, with 39% of sales now coming from outside the US.
For meningitis, sales increased 16%, driven by Bexsero, which achieved blockbuster status with more than GBP 1 billion in annual sales. This experience and track record of success will play an essential role as we launch the next generation of vaccines coming through the pipeline. If you'd now please turn to the next slide. We're committed to delivering profitable growth to 2026 and beyond, and I remain confident, very confident, to deliver the ambition that we laid out in June of 2021. Arexvy is the first U.S. FDA and now approved, European-approved vaccine for RSV, with peak sales potential greater than GBP 3 billion. Our launch preparations are well underway in the U.S. and Europe before the next RSV season. As you heard earlier, we presented the second season data at ACIP last week.
Next, we anticipate additional flu COVID data and phase III data for high-risk adults from 50 to 59 years of age, plus the regulatory approval of Arexvy in Japan during the second half of this year. Full to 2026 sales for influenza increased to GBP 714, We started phase I and phase II clinical trials for COVID and multivalent mRNA flu vaccine candidates. We believe that there is a significant future opportunity for seasonal doublet flu COVID mRNA combinations, which could potentially deliver more than $3 billion in peak year sales. In contrast, we expect RSV, with insight from the second season data, will be dominated by protein-based multi-season vaccines. For meningitis, we recently announced positive phase III data, the MenABCWY, which met all primary endpoints.
This is the only five-in-one vaccine to demonstrate immunological effectiveness across 110 MenB, diverse MenB invasive strains, with potential peak sales between GBP 1 billion and GBP 2 billion. With a highly innovative MAPS technology and access to next generation pneumococcal prophylaxis vaccine candidates, we'll realize the value of the 24 and 30+ valent candidates in a market estimated to be greater than GBP 7 billion by 2028, where pediatric is around 75% of the opportunity. We estimate peak sales being greater than GBP 4 billion, with launches targeted to later in the decade. Our growing anti-infectives portfolio now features gepotidacintidacintidacintidacin to treat uncomplicated UTIs, tebipenem to treat complicated UTIs, and Brexafemme, which treats vulvovaginal candidiasis and reduces the incidence of recurrent VVC.
gepotidacintidacintidacintidacin is the first in a new class of oral antibiotics in over 20 years and has peak year sales potential of between half and 1 billion GBP. tebipenem has phase III data expected in 2025+, when combined with Brexafemme, offers additional benefits to underserved populations, with the potential to generate significant sales in a synergistic fashion. We estimate our anti-infectives portfolio could reach peak year sales of up to 2 billion GBP. In 2022, Shingrix delivered record sales of nearly 3 billion GBP, and we're well on our way to doubling Shingrix revenue by 2026. We will be in 35 markets by 2024 and are exploring lifecycle management opportunities, including the need for a booster and the early but growing body of published evidence that suggests shingles vaccination is associated with a reduction in the risk of dementia.
Lastly, bepirovirsen could be a functional cure for chronic hepatitis B, with potential peak year sales of more than GBP 2 billion. Our phase III confirmatory trials will assess patients who are stable on nucleotides and nucleosides, We remain excited about the promise of bepirovirsen as a potential cornerstone therapy in sequential combination or monotherapy treatment. Next slide, please. As you've already heard, the infectious disease market is forecast to grow to more than GBP 100 billion, We've delivered continued momentum with sales of GBP 16 billion. As Tony highlighted, we have a strong and exciting infectious disease pipeline, including many first-in-class and best-in-class opportunities, with around 22 data readouts and 25 regulatory decisions between now and 2031.
We understand the significant and growing burden of infectious diseases for patients and society. We are confident that we can deliver our ambition to transform the prevention and treatment of infectious diseases for billions of people. Our world-leading infectious disease pipeline, coupled with our Continued strong commercial execution and momentum, will deliver strong revenues, high margins, and profitable growth for GSK from 2026 and beyond. Thank you. Back to you, Mick.
Thanks very much, Luke. Sorry, just, my slide was refusing to change. Just for everyone's benefit, we now have a couple of minutes to join one of the virtual breakout sessions, which starts at 2:30. As I say, a couple of minutes. Just as a reminder, we will run each of these breakout sessions twice so that participants can attend 2 of their choosing. We'll come back together as a larger group, returning for a final Q&A session with Tony, Luke, and Deborah, and then the broader teams that have participated in the breakouts. Details are available on the Zoom events landing page or via the email that you'll have received when you registered. After the event, as we said earlier, all of the presentations, materials, and on-demand videos will be available on gsk.com.
Finally, let me take the opportunity to thank Emma, Tony, and Luke for their presentations and to all of you for your interest in GSK. We'll see you back here a little bit later, but please disconnect now, and we'll see you in one of the breakout sessions. Thank you very much.
Okay, just going to give a minute or two for a number of attendees to join in here.
We will be in one minute.
Yep, we are live now. Okay, I see we have a number of attendees, so we're going to get started in the interest of time. Hello, everyone. Welcome to breakout session on seasonal respiratory viruses. I'm Jeff McLaughlin from the Investor Relations team, and I have with me Phil Dormitzer, the Senior Vice President and Global Head of Vaccines R&D, and Christi Kelsey , who's the Senior Vice President and Global Head of Vaccines Commercial. If we move to this next slide is our usual safe harbor statement. As a reminder, this event is also being recorded. The purpose of the session is to give you a chance to ask questions. First, we have a brief introduction from Phil and Kristi about some of the exciting work we are doing, specifically to help prevent seasonal respiratory viruses. I will now hand over to Phil, for slide 4.
Thank you, Jeff. GSK has pioneered, novel research methods and technologies to help protect people from infectious diseases for the last 70 years. We have a strong track record of successful commercial innovations. What are we referring to when we talk about seasonal respiratory viruses? By seasonal, we mean respiratory viruses that circulate at about the same time every year. Today, we're focused on RSV, that's respiratory syncytial virus, influenza virus, and SARS-CoV-2, that causes COVID-19. Respiratory syncytial virus, RSV, is talked about a lot lately, because first, it was a very bad RSV season in 2022, 2023.
Second, for the first time ever, we now have vaccines approved to help prevent this common virus, which can nevertheless cause devastating disease, especially for certain adults, such as those with weakened immune systems or those with comorbidities, as is the case for many older people. Each year in the United States, RSV is responsible for about 177,000 hospitalizations among adults 65 older and 14,000 deaths.
Furthermore, adults with underlying conditions are more likely to seek medical services and have higher hospitalization rates than those without comorbidities. According to the CDC, more than 90% of adults hospitalized for RSV have underlying medical conditions. Influenza is caused by another common respiratory virus. That one affects approximately 1 billion people annually and can lead to severe complications, including pneumonia, heart failure, and death. Of course, SARS-CoV-2 has caused over 750 million confirmed cases of COVID-19 worldwide and has caused millions of deaths. One important distinction among these three seasonal respiratory viruses is that RSV, unlike influenza virus and SARS-CoV-2, is genetically stable.
It comes in, two, varieties, subtype A and B, but these are also stable, and it does not change over time the way influenza virus or SARS-CoV-2 does, so we do not anticipate a need for regular strain changes. I'll now pass on to Christy to outline the opportunity.
Phil and I get a chance to join together. Thank you, Jeff, and thank you, Phil, for the opportunity that we want to discuss today. As I'm sure you are all aware, Arexvy was the world's first approved respiratory syncytial virus vaccine for older adults, and at pivotal phase 3 clinical study, Arexvy had exceptional efficacy, with an impressive 94.6% efficacy in people with at least one comorbidity and 82.6% overall efficacy against lower respiratory tract disease caused by RSV. We know patients with underlying medical conditions are those that actually suffer the most, but more importantly, drive significant costs to the healthcare system. In talking with our customers since approval, we see this as a key differentiator for Arexvy.
We've shared many times we have leadership ambition, and we believe Arexvy's profile is matched to this leadership ambition. This will be a multi-billion annual sales potential vaccine, and as you heard from the introductory comments from both Emma and Tony, this further strengthens our presence in the very important and growing adult vaccination space. If we go to the next slide, I want to give a bit of a voice-over of our more recent events that we've had for Arexvy. You would have seen last week at the CDC's Advisory Committee on Immunization Practices, or ACIP, we presented the much-anticipated Season 2 data, indicating that Arexvy provides protection over 2 full RSV seasons. We also saw a consistent tolerability profile. Importantly, GSK's follow-up period was 18 months.
Based on the evidence that I spoke about in the last slide, as well as the safety and continued efficacy demonstrated over two complete seasons, the committee voted to recommend the use of Arexvy for the prevention of RSV disease in adults aged 60 and above, with shared clinical decision-making. This means that in the U.S., there's 77 million older adults that now have access to this vaccine, and we are very excited to get going. It's important also to note, while this is a significant milestone, we are just getting started. Arexvy has a very robust lifecycle management plan with additional data forthcoming. We presented our flu co-administration data, which we have co-ad data in our label, and we also presented to ACIP flu co-ad data with adjuvant and high-dose flu.
Our phase 3 study in patients 50 to 59 is fully enrolled, and that data will file shortly. We also expect additional regulatory decisions in the back half of the year. For now, with our current recommendation for patients 60 and above, our launch efforts are well advanced. Stock is in the distribution center, and we are ready.
Well, thanks, Christy. You know, currently available flu vaccines are suboptimal. One reason for this is that the viral antigens of flu drift on circulating strains. In fact, they drift so quickly that you can even see a change from the time that manufacturers start to make doses for a seasonal flu vaccine campaign until when they're administered, so there's a high risk of mismatched antigens. Now, mRNA vaccines have the potential to disrupt the flu market, which is estimated to be more than $8 billion by 2028. mRNA can be manufactured quickly and easily, and it can be readily adapted to keep up with the changes in the virus, making it an ideal technology for responding to emerging and changing influenza strains....
Along with our collaboration partners at CureVac, we announced preliminary positive phase I data from monovalent flu mRNA vaccine that showed a strong functional antibody response, and that's even at the lowest dose level tested. We saw very good tolerability at much higher dose levels. We're now developing a next-generation multivalent mRNA flu vaccine that can be used to protect against multiple influenza strains. The phase I/II trials are now underway, and we're encouraged by what we've seen with the CureVac platform thus far, and we look forward to the multivalent data at the end of this year or beginning of 2024. Next slide, please. We're also pursuing a SARS-CoV-2 mRNA vaccine using nucleoside-modified RNA on the CureVac sequence optimized platform.
We believe that combination of nucleoside modification and the CureVac platform really give us the potential to combine strong immune responses and an acceptable tolerability profile, which is going to be particularly important for differentiation and essential for consumer acceptance, especially as we get past the pandemic. With this, we're well positioned to introduce mRNA combination vaccine to help protect against these variable seasonal respiratory viruses. The idea is we get to a more convenient and effective patient scheduling schedules, and that can lead to higher immunization rates. Next slide, please. Now, we've invested significantly in our mRNA capabilities and R&D to have commercially ready manufacturing capabilities.
As you can see from our clinical development program at the bottom of this screen, we plan to introduce mRNA vaccines that can contribute to profitable growth in the second half of this decade. Next slide, please. In summary, key upcoming events include launching Arexvy and building further clinical evidence to support its profile. Next steps include acquiring additional flu co-administration data. Data in the 50 to 59-year-olds, including high-risk adults. There will be a phase III study and further regulatory submissions, such as the recent decision from Japan, as well. On mRNA, the focus is on developing the optimal platform for multivalent and combinational seasonal respiratory disease vaccines, with ongoing work to support a profile that can achieve the needed efficacy with good tolerability.
As a reminder, we look forward to the multivalent data by the end of this year or the beginning of 2024. We're committed to develop the innovative vaccines that can help protect people from respiratory viruses, building from our long and successful history in both vaccines and respiratory health. As our pipeline emerges, we can continue to make significant and positive contributions to help prevent infectious diseases worldwide. Now we'll move to discussion, and I'll hand it back to Jeff to moderate the Q&A.
Great. Thanks, Phil. We'll now go to Q&A, and as a reminder, to ask a question in Zoom, just raise your hand using the icon in the menu bar, and I will then open your line so that you can ask your question. If you have happened to join via telephone, please press star nine to register a question and star six to unmute if needed. Can I please just remind everyone to limit your questions to just one? There's a number of individuals who have attended this session, and we want everybody to have the opportunity to ask a question if they'd like to do so. Additionally, as you can see, Luke Miels, our Chief Commercial Officer, has joined this breakout session and may also offer some additional comments during the Q&A session.
We will now take our first question, and it will be from James Gordon. James, I'm going to allow you to ask a question now.
Hello. Thanks for letting me take the question. Can you hear me okay?
Yeah, we hear you, James.
Lovely. First question on RSV vaccine then. The GBP 3 billion+ peak sales was reiterated, and I think you're also saying GBP 5 billion+ market. Just curious, given there didn't seem to be a revaccination benefit for the second year, and maybe was the ACIP recommendation a little bit lukewarm in that they noted moderate efficacy and SCDM status, does that reduce the market potential at all versus what you were originally hoping for? If not, why not? Is it because of higher pricing, or is there another offset that we've missed? You also said more than GBP 3 billion, that would appear to assume more than 50% market share. Just to think the updated thinking around your market share and why you'd have more than half the market.
Absolutely, James, and thanks for the question. As far as market size, I think the way we're looking at the Shared Clinical Decision Making recommendation is this will not slow us down. We expect a significant ramp-up in the first year or two. We know there's a significant unmet need. We're very, quite frankly, familiar with this clinical pathway with our work on Bexsero, just given that RSV happens in this kind of triple-demic season, we're already hearing both from consumers and HCPs that they're ready and willing to vaccinate. The awareness piece doesn't change our view on market size. As far as your question on revaccination, of course, we'll have to wait for further data to know what the revaccination profile will look like.
That will take a few seasons before we can state that, but for now, our view is market remains large. What we lose on volume because of the multi-season profile, we will make up on price, and you would have seen our price statement that we made at ACIP. We're ready to go. We have experience here with Bexsero, and we're very familiar with the plight of the respiratory patient. We still see it as a multi-billion dollar opportunity. Luke, I don't know if there's any builds you have?
Yeah, thanks, Christy. I think James also, the other way to look at this is, this is gonna place it in the realm of the infrastructure we have in terms of Trelegy and Shingrix to interact with healthcare professionals, physicians, nurses. These are people who qualify as HCPs under the ACIP classification. The fact that we have the secondary data in our label and can use that, and we intend to use that very actively. I think the other thing is, the fact that you've got 2 seasons coverage is gonna be very compelling for physicians and patients. If you know, you can be very confident we'll adjust for that on the price. That's just going to be net, I think, quite compelling for individuals at high risk of respiratory infection.
Maybe, James, the only other build I would add is, if you start to benchmark other vaccines that fall into Shared Clinical Decision Making, the Inflation Reduction Act is certainly a new component now that we have in the marketplace. We know that this largely, this vaccine will be covered with zero out-of-pocket copay, and that certainly factors into uptake as well.
Great. Thank you.
Thanks for the question, James. We're gonna just move it along here. I'm gonna go with Jo Walton next. Jo, I'm gonna allow you to talk now, if you would like to unmute.
Thank you. I'm afraid I'm going to go back to the same topic as James. In ACIP, the experts did seem to be surprised that there didn't appear to be any benefit of giving an additional dose in the 2nd year, and they seemed to query whether this might, in fact, be a one-off opportunity. It wasn't something that you would come and have year after year. Can you give us a timeframe on which we'll have data where we can be confident that you do need to be boosted every 2 years, and that the extra dosing coming in is gonna reboost you so that you get a real benefit from this? That, to me, appeared to be one of the areas of concern that they had. A timeline to put that one safely to bed, please.
Yeah. Thanks, Jo, for the question. I would say, it's certainly an area of curiosity. You know, we have to remember, with this being the world's first vaccine, we're still learning this pathogen, so it will take time to assess, duration of protection. I'll hand over to Phil, who's right next to me, to talk about how we're continuing to evaluate this in our clinical trial program.
You know, the study, this is our pivotal study, will go on for an additional season, and we'll be testing what it looks like to boost after 2 years, and all probability, to look at what a boost will look like after 3 years. This is a case where understanding the best intervals for boosting will take some time because we need to allow the time to allow from the last boost to the next boost, so we can look at that spacing. Those plans are evolving since we've seen these data.
Great. Thanks for the question, Jo. We're gonna go around to the next question. It will be from Evan Wang. Evan, I'm allowing you to talk now.
Great, thanks. Can you hear me?
Yes.
Great. This is Evan Wang on for Seamus. Can you walk through some of your influenza clinical development, you know, strategy and timelines? I think you highlight clinical development through 2026 and April 2027. I know you guys are evaluating a few of the different constructs. Can you talk through some of the advantage of the types of constructs that you guys are looking at and some of your assumptions in terms of, I guess, what's needed to get to phase 3 in terms of, I guess, some of the study design features and, you know, whether it's likely to require multiple seasons to kind of look at efficacy? Thanks.
We really are doing this in a couple of stages. The first stage was to get the platform right, to make sure that we saw that we could get that gap between the minimum immunogenic dose and even mini-immunogenic actually looks quite good, and a well-tolerated dose, knowing that you'd have to get up to at least four valent and possibly higher. We've now moved on to now we're now in the clinic with our multivalent study, where we're actually trying a variety of different formulations to find the optimal one. Once we pick the optimal formulation, then we'll move into the phase three trials, and initially testing for safety and immunogenicity, and likely moving on to efficacy as well.
The exact timelines, I don't think we've released the timelines all the way forward, but we can say that we're in the clinic now with our multivalent formulations. I should also say we have a COVID-19 program that's going on as well, and then we'll also tend to move on to combinations of RSV and COVID-19, excuse me, influenza and COVID-19 vaccines. We'll have this on the first day. We'll start to see the end of this at the beginning of next year.
Great. Thanks, Phil. I'm gonna remove you, Evan, from permission. We have next question is from Steve Scala, from Cowen, from TD Cowen, that is. Right, Steve, I'm gonna allow you to talk here.
Thank you, Jeff. Question is: Do you expect pharmacies will stock both the GSK and Pfizer RSV vaccines, or only one? What do you anticipate will be the deciding factors? Will it be anything more than price? Related to that, Roger, as a medical doctor, if you worked in a clinic that had only the Pfizer RSV vaccine, what would you do? Thank you.
Maybe I'll take that. I think, first of all, what we are hearing, and we've actually done some research since ACIP, is 90% of pharmacists are actually ready and willing to recommend this vaccine. That does speak to the importance of the awareness that is out there in the marketplace. As far as will pharmacies stock one, you know, our view is if they stock one, it should be ours for a few reasons. We know largely, especially with a shared clinical decision-making recommendation, there's a lot of interest to make sure that we vaccinate patients with comorbidities first. I mentioned earlier, they have the highest burden on the healthcare system, and we have the strongest data set in that very important population.
I think secondly, when you look at our administration, we have as far as the steps to administer, it's what pharmacists are very familiar with. It's similar to Shingrix, there isn't additional training that needs. Price is always considered, of course, we have a very, you know, a price that is one, it's from a health economic perspective, it offers value, and also it was recommended and valued by the ACIP as being a good use of resources. I think if they do stock one, I think we're well positioned for that, for that to be our vaccine, those conversations are actively ongoing as we speak. I think there's a second part to your question, Steve. I may have missed it.
As far as if I think if I was a physician?
Well, Dr. Dormitzer is a physician, so I thought I would ask him.
I'll be very careful with this answer here, because I am a physician, and I sign a statement where I practice that I will not do anything that has to do with my employment with GSK in my prescribing decisions. What I would say is it's important that older adults get immunized against RSV, and I have tremendous confidence that we have a great RSV vaccine from GSK.
Thank you.
That's fair. Thanks, Steve. I'm not seeing any additional questions, so just if anybody would like to ask a question, as a reminder, we have about five minutes to go before we will break from this session. You can please raise your hand. I see a new question come up here from Dominic Lunn. Dominic, I'm going to allow you to talk here, and you can ask your question if you unmute.
Hi there. Yeah, I just had one question on Shingrix's life cycle management, and, you know, you talked about the dementia reduction potential. I was just wondering if you could talk a bit more about exactly what you've seen there, how significant this life cycle management could be, and talk about any incremental work you may be doing to do this and the potential timelines.
Maybe I'll address the sort of scientific aspects of the question. It's an observational study that came out that takes advantage of, you know, very unusual circumstances when not Shingrix, but ZOSTAVAX was introduced really almost at a moment in a population and a reduction in dementia was seen. I mean, it's a fascinating finding, and there are a number of potential explanations for it. Empirically, in a observational study, you do see a decrease in dementia. You know, one thing I can say that we're doing now is interrogating the data that we can find observationally, using even machine learning algorithms, et cetera, to really try to understand this finding. I don't think observational studies will give us a mechanism, but to some degree, from a public health perspective, it doesn't matter.
What the mechanism is, if whether it is improving the overall health of older adults, makes them less prone, or, for example, subclinical dementia, to become full-blown dementia, or whether the herpes viruses, the neurotropic herpes viruses, have a fundamental pathogenic role in dementia, I don't think any of us know. In any case, it does appear that at least with ZOSTAVAX, and it would be very interesting to see if the same is true for Shingrix, that immunization is associated with reduced dementia in this study.
Thanks for that question, Dominic. I'm going to fly through. We have a number of additional hands that just were raised. Keep in mind, although the team here is obviously highly capable of addressing the Shingrix questions, there is another breakout session that touches on Shingrix in chronic viral conditions. If you have further questions on that subject matter, that could be a good option for breakout session, the second 30-minute block. We're gonna go. It looks like Harry Gillis has a question. Harry, I'm gonna go to you, allow you to talk.
Hi, thanks for taking the question. Just a quick one. I was wondering if you're looking at any RSV combinations with HMPV or PIV, because we've seen a number of your competitors are looking at these combos. Thank you.
No, I don't know that we've made any announcements to that effect. I can tell you from a scientific perspective, it certainly makes a lot of sense. You know, knowing how to make an RSV vaccine, same work to make an HMPV vaccine. It's certainly a logical combination. I'm sort of saying exactly what we're doing. I would say that certainly makes a lot of sense.
Harry, my only build commercially is we obviously know a fair amount about the dynamics of combination vaccine marketplaces from our experience in the pediatric setting. We know this offers tremendous convenience over time. I think given the questions about revaccination timing between kind of stable viruses, less stable viruses, we need to let the, you know, the data continue to evolve so that we can actually have the right combination with the right frequency. That will take some time, and certainly one we're watching quite closely.
Great. Thanks for the question, Harry. We've got just maybe 1 minute to go, and several other individuals are back in the queue who've already had a question. Jo, I saw you first, so I'm gonna go to Jo Walton for 1 final question here.
Thank you. I'm going back to ACIP and your confidence that you have a better vaccine than Pfizer. The independent people at ACIP said that if you were to give 1 million vaccinations in the over 65s, you'd avoid 25,000 outpatient visits with the Pfizer one, only 23,000 outpatient visits with the GSK one. There also appeared to be some concern about the possible use of the adjuvant, given that there is, in their view, an excess of neurology effects using the adjuvant in Shingrix. My question is, how do you counter that? Presumably, Pfizer can go out and just hand that. That was an independent ACIP bit of research. Here, pharmacist, I can tell you that ACIP thinks that ours will work slightly better than GSK's, for whatever reason.
secondly, do you think that there's any concern that you would not be allowed to do co-administration at any point at the Shingrix, given that you are adding that extra adjuvant, which may have a, an adverse effect?
No, it's a great question. I think I'll defer to Phil on the adjuvant question and kind of our co-ad thoughts when we're starting to think about Shingrix and RSV vaccine. As far as the health economic discussion at ACIP, I think what's important to note is that the analysis that was run, obviously independently, you have to really understand what you're looking at as far as different case definitions that were used in the model. On balance, if you look at the conclusions, you know, ACIP did demonstrate that both offered efficient allocation of resources. If you look, dig deeper into the case definitions, you're definitely not looking at an apples to apples comparison. That's important to note.
I think the other important distinction when you're into the modeling, is understanding that our follow-up time was longer at 18 months, up to 21 months, which we should take into consideration a virus that ultimately wanes. I think that's an important distinction of the analysis that was done. I know in our press release that we put out there, we showed the different efficacy endpoints over time, both season 1 and season 2, as far as the midpoint, that I think offers some interesting data to help make independent comparisons. I'll defer to Phil on the adjuvant.
I'd say that the AS01 adjuvant is an adjuvant with which we have a tremendous amount of experience, particularly through Shingrix. The RSV vaccine has half the dose of adjuvant that Shingrix has, and Shingrix has an outstanding safety record. In addition, what we've really seen is consistent high efficacy, especially high in those with comorbidities, and particularly high against the severe disease. As this is a vaccine for older adults, where immune senescence can be an issue, we think that the adjuvant is a contributor to that very consistent high efficacy, and we're confident in the safety record that we've seen from Shingrix.
Thus far, have no reason to question that we are likely to see something similar, although of course, we will continue to monitor, as we always do, after launch.
The last thing I would add is, we'll need to see how this plays out, but, you know, one thing we've seen over time is Shingrix does not have to be administered during flu season. So, you know, having Shingrix administered earlier in the year, does open up more space now that we have RSV coming in. The lack of co-administration with Shingrix, we don't see as a barrier at this time.
Thanks, Phil and Christy. Luke, any final remarks from you, or shall I close things off? Okay. Well, thank you, everybody. Great session, great discussion. You now have about 15 minutes to join the next virtual breakout session, which will start at 3:15 P.M. for the UK timing, or 10:15 A.M. on the East Coast, or you can do the math from there. Details are available on the Zoom events landing page, or via the email that you will have received. All presentation and event recordings from each breakout session will be available on gsk.com. So if you didn't catch something, and you want to go back and listen again, you'll have that opportunity. Just thank you to the panelists and for all the attendees, and for your interest in GSK. You may now disconnect and find your way to the next breakout session.
Thanks, everyone.
Going. Hello, everyone. Welcome to this session, focused on invasive bacterial and fungal infections. I'm Josh Williams from the investor relations team, and today I'm joined by Kumaran Vadivelu, the Head of Vaccines R&D Development, and Rob Bowers, the Head of General Medicines Commercial. On our slide 2 is our usual safe harbor statement. The purpose of the session is to give you the opportunity to ask questions. We'll start with around a 10-minute presentation from Kumaran and Rob, on some of the exciting work that is happening in the bacterial infections and fungal infections space. Kumaran, over to you.
Thank you, Josh. I'm thrilled to join you this afternoon to share some of the exciting work in vaccines R&D. As a global healthcare company committed to finding new ways to prevent and treat disease, one of our focus areas is bacterial and fungal infections. On this slide, you can see some of the common infections that continue to significantly impact patients worldwide. For example, vaccine-preventable diseases like meningitis and pneumococcal continue to hospitalize and kill people every year. In the U.S., more than 150,000 people are hospitalized from pneumococcal pneumonia every year. Even with antibiotic treatment, 10%-15% of people infected with meningococcal disease die. These statistics underscore the urgent need for improved vaccines to address this pressing medical need. Over to you, Rob.
Thanks, Kumaran. There also remains a significant unmet need for patients affected by common community infections like urinary tract infections and vulvovaginal candidiasis, which I'll refer to as VVC. These diseases are among the most common infections that women will experience, but their impact on quality of life for patients is often overlooked, especially given the burden of resistance and recurrence in these patients, combined with the lack of innovation for decades. For example, the lack of new oral options for complicated UTI means that patients with resistant infections have to be treated at hospital with IV antibiotics. Over the next few slides, we'll give you an overview of our key pipeline products in this space, and then we'll open up for Q&A. Next slide, please. Over to you, Kumaran.
Yeah. Thanks, Rob. The first program I would like to share with you is our pentavalent MenABCWY meningococcal vaccine, a vaccine designed for the broadest meningococcal disease coverage. Our five-in-one MenABCWY vaccine builds on the legacy of Bexsero, our market-leading meningitis B vaccine, and integrates MENVEO, covering ACWY strains. There is an opportunity to improve immunization rates among U.S. adolescents for MenB, which currently only at around 30% penetration. Recently, we presented preliminary pivotal data on our five-in-one vaccine candidate, which met all primary endpoints, demonstrating statistical non-inferiority compared to Bexsero and MENVEO, with an acceptable safety profile. Further, our pentavalent is the only investigational vaccine to have shown immunological effectiveness against a panel of 110 diverse MenB strains, which account for 95% of those circulating in the U.S.
We are on track for a US regulatory submission in 2024, and our lifecycle management efforts feature additional work to pursue global licensure outside the US and expansion into infant population. We expect combination vaccines to drive incremental growth in the overall meningitis market by improving compliance and immunization rates. As illustrated in the table on the slide, the introduction of a pentavalent meningitis vaccine for US adolescents could potentially reduce number of required doses for those aged 16 to 18. Please turn to the next slide. Before the Affinivax acquisition, we had a gap in our vaccines R&D portfolio, as we were limited in our assets for pneumococcal disease, a $7 billion market opportunity. Despite the routine recommendation and widespread use of pneumococcal conjugate vaccines, we know there is still a considerable disease burden among older adults and young infants.
Current conjugate vaccine technology limits potential coverage to 20 out of the 100 known pneumococcal serotypes and provides suboptimal protection for some serotypes, such as serotype 3. The most successful next-generation pneumococcal vaccine will provide both higher serotype coverage and broader immune responses. Referring to the bar chart on the right slide of the slide, you can see that introducing a 24-valent pneumococcal vaccine, developed using our MAPS technology, could boost coverage to above 60% of the disease. Further, an expansion to a 30-valent plus formulation could increase coverage to over 90% of the disease. Next slide. This figure represents the differences between MAPS technology on the left panel and conventional conjugate technology on the right panel. MAPS technology uses high-affinity biotin-rhizavidin binding interactions to present immunogenic epitopes of both pneumococcal polysaccharides and pneumococcal antigens to induce B-cell and T-cell responses for robust immune protection.
B-cells initiate response to the polysaccharides, and B and T-cells respond to the protein antigen. MAPS offers two distinct advantages over traditional pneumococcal conjugate vaccines. First, MAPS facilitates higher valency. This means that expanding coverage beyond 20-30 serotypes is a much easier proposition compared to chemical conjugation. Another key differentiator is that MAPS complex is more immunogenic and introduces an additional form of immunity, specifically T-cell mediated pneumococcal specific anti-protein immunity. This is unique to MAPS technology. Traditional glycoconjugate vaccines, like PCV, employ a protein carrier, CRM197, that's completely unrelated to pneumococcal disease and therefore do not stimulate pneumococcal specific anti-protein immunity. Next slide. This slide presents the results of phase 2, involving older adults, demonstrating the clinical proof of concept for the technology, as well as the MAPS 24-valent candidate, which forms the foundation for proceeding to phase 3.
We are confident that our vaccine candidate, leveraging MAPS technology, holds significant promise to reshape the pneumococcal vaccine landscape due to, number 1, its high valency. Number 2, robust anti-polysaccharide immunity, as shown in phase 2 data presented on this slide, including higher response for most serotypes, particularly for serotype three against PCV13. Third, a broader immune response facilitated by the inclusion of pneumococcal protein, which is unique to MAPS technology. Collectively, MAPS technology attributes are critical for, number 1, improved disease coverage, number 2, potentially enhancing efficacy against invasive diseases, and third, offering greater impact on mucosal diseases like pneumonia and otitis media. We are making progress in advancing our development with the aim to be the first to market with the 24-valent vaccine.
We expect phase III trials for adults to start in 2024, and targeting the launch of a pediatric vaccine before the end of this decade. Additionally, we are on track to advance MAPS 30-plus valent formulation into the clinic in 2024. At this point, I would like to pass the presentation over to Rob.
Thanks, Kumaran. In addition to preventing infections, we must continue researching and developing new treatments for bacterial and fungal infections, including those at the community level. ESBL-producing bacteria can negate the effects of commonly used beta-lactam antibiotics. As you can see from the chart on the top left here, rates of ESBL-producing bacteria are increasing in complicated urinary tract infections in the U.S. Majority of these bacteria are multi-drug resistant to any oral treatment, hence the reason they are deemed a priority pathogen by both the WHO and the U.S. Centers for Disease Control. This necessitates IV therapy for a condition that would previously have been treated with oral therapy in the community setting.
For VVC, our market research shows HCPs see about 30% of their patients as complicated or challenging to treat due to the impact of resistance or recurrence, with no other oral options for patients after fluconazole. On the right-hand side of the slide, we've outlined what we see as the key criteria that are essential to developing a successful portfolio and becoming commercial leaders in this space. First, we're focused primarily on infections with large populations and significant unmet needs. By focusing on the portion of these patients with the highest unmet need, for example, patients with resistance or recurrence on existing therapy, which is about a third per group, we have a portfolio with the potential to reach $2 billion in peak year sales. Additionally, we're focused only on novel, first-in-class assets that are differentiated and have efficacy against resistant pathogens.
All of our assets address or have the potential to address WHO priority pathogens. This designation is an important signifier of high and increasing unmet need, it's commonly used as a key qualifying criteria for future pull incentive policies that are being developed in the U.S., Europe, and the U.K., and that are designed to incentivize and reward antibiotic innovation. Finally, we know that bringing oral outpatient treatments for common community infections has strong commercial value, which is aligned to outcome-driven impacts, like reducing hospitalizations and reducing pressure on the hospital system. We see a significant opportunity to lead in this space and to build a unique portfolio of first-in-class, best-in-class medicines with synergistic strategies.
This large unmet need in a market with decreasing competition, matched with our commercial and R&D capabilities in this space, makes us confident that we'll be a key leader in this area. With new policy incentives and pull incentives emerging, GSK is well positioned for these significant upsides should they come to fruition. Next slide, please, Joy. On this slide, you can see an overview of the anti-infective assets we have invested in with near-term potential. All these assets are novel or first-in-class oral options for community or outpatient infections with growing resistance. Starting on the left with gepotidacintidacintidacintidacin, this is a first-in-class triazaacenaphthylene, or a TZAP antibiotic, and its distinct mechanism of action provides activity and broad coverage against most strains of E. coli, including those resistant to current antibiotics such as fluoroquinolones and ESBL producers.
In November, we announced that our phase 3 studies were stopped early for efficacy, following a pre-planned interim analysis by an independent data monitoring committee. Data was presented at ECCMID, demonstrating non-inferiority against the most commonly used first-line treatment, nitrofurantoin, in both phase 3 trials and additional superiority in one of those trials. Gefo showed a consistent treatment effect in patients with the highest unmet medical need, those with resistance, a history of recurrence, or aged greater than 50 years. Despite black box warnings and FDA guidance to reserve their use in UTIs only for patients with no alternative options, fluoroquinolones are still commonly used as second-line antibiotics in the US, with close to 25% market share. Gefo has the potential to provide a valuable new treatment option that can displace fluoroquinolones, preserving fluoroquinolone use for other serious infections and in line with good antibiotic stewardship practice.
Gefo only needs to displace one-fifth of current fluoroquinolone use to become a $1 billion medicine in the U.S. We're currently preparing the U.S. submission. Given the opportunity we see in this space, and in order to build out a world-leading infectious diseases portfolio, we announced an exclusive license agreement with Spero Therapeutics for tebipenem, a late-stage antibiotic that may treat complicated urinary tract infections. Tebipenem has a clear U.S. FDA regulatory path to potential approval, with phase III clinical trials starting in 2023, following encouraging U.S. FDA regulatory feedback on the proposed clinical trial design. Finally, on the right, with Brexafemme.
In March, we added a third asset to our portfolio through an exclusive agreement with SCYNEXIS to commercialize and further develop Brexafemme, a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi, including VVC, and with potential in invasive candidiasis. Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals, which inhibit fungal growth. It is the only oral antifungal U.S. FDA-approved treatment for VVC and reduction in the instance of recurrent VVC. GSK plans to relaunch the VVC indication, and its plans to launch are underway. We also have a phase Three program in invasive candidiasis. Candida auris is an emerging multidrug-resistant fungus cited as an urgent threat by the U.S. CDC, alongside other serious drug-resistant Candida species. We're developing Brexafemme to address this emerging market.
Next slide, please. We are looking forward to the opportunities we have for our bacterial and fungal infection assets, including meningitis, Streptococcus pneumoniae, and our anti-infectives portfolio. For meningitis, we're working closely with regulatory agencies to review the complete phase III data before U.S. regulatory submission in 2024. On pneumococcal disease, we plan to start our 24-valent vaccine phase III program in 2024, and move our 30-plus valent into the clinic in 2024. Finally, on our anti-infectives portfolio, we're excited about the significant opportunity to lead in this space and to build a unique portfolio of first-in-class, best-in-class medicines with synergistic strategies. With that, we'll move to the discussion. I'll hand it back to Josh to moderate the Q&A.
That's great. Thank you very much, Rob. We will now go to Q&A, where we are also joined by David Redfern, President of Corporate Development. As a reminder, to ask a question in Zoom, please raise your hand using the icon in the menu bar. I will then open your lines, so you can ask a question. If you've joined Zoom using the telephone numbers provided, please press star nine to register a question and star six to unmute if needed. Can I please remind everyone to limit questions to one to be fair to all participants, please? Thanks in advance. We will now take the first question from Seamus Fernandez of Guggenheim. Seamus, I'm just gonna unmute you to allow you to talk. If you could unmute yourself and ask your question, please.
Okay, great. Thanks for the question. My question really is on the pneumococcal vaccine and the MAPS technology. You know, just hoping you could give us a little bit more color on when we'll see the phase II data from in Pedes and then the pediatric phase II data. Also, you know, when you say that you're starting your programs next year, I believe there were some issues with regard to manufacturing for a full sort of pediatric phase III clinical trial being initiated. Can you just update us on what the manufacturing issues are and those timelines? It seems a little bit confusing that the adult trials can begin, the pediatric trials are delayed. Thanks.
Thanks a lot for the question. I can provide a bit more color on our pneumococcal program. First thing is, Phase 1 for the pediatric population has been completed, with it for the 24-valent vaccine candidate. The ongoing Phase 2 trial, which started in June 2022, is temporarily paused following an audit finding regarding the fill and finish presentation of the vaccine. The emerging data we see from the pediatric population is very reassuring about the technology's potential in this age group, and we are working diligently to resolve this matter to resume the study as soon as possible, so Phase 2 trial in pediatric population. As I communicated earlier, we plan to start Phase 3 trials in adult population in 2024, and we remain committed to bring the pediatric vaccine to the market before end of this decade.
Great. Thank you.
Thank you, Seamus. I think I saw Graham Parry from Bank of America raise his hand. Graham, if you still want to ask a question, I'm just gonna allow you to talk, if you could unmute, please.
Yeah, great. Thanks. It's a follow-up question actually on the pneumococcal. Just in terms of the phase III trial design that you'd expect in adults, what would you expect to use as the comparator there? Do you see Prevenar 20 and Pneumovax 23 as being best comparators there? Although, you know, prior trials have been run against Prevenar 13. Separately, just going back to the pediatric, just any kind of timeline you can give us on when do you expect to be able to resume the study? I think that was slated for data, I think, in 2024. Is that realistically going to be a post-2024 readout on that phase II study now, or do you think we should be able to see some data in pediatrics in 2024? Thank you.
First thing is, I'll take the question on pediatric data first. As I said earlier, the ongoing phase II trial, which started in June 2022, is temporarily paused, and we are working to resolve this matter as soon as possible so that we can resume study start. We will provide more guidance later on the phase II data readout timeline as soon as we have more clarity on the study start timelines. With regard to phase III adult program, earlier during the phase II, we compared the vaccine against Prevenar 13, which is a highly immunogenic vaccine, we still demonstrated robust immune response outperforming PCV13 for several serotypes, including serotype 3. We know today PCV20 is the new standard of care.
At the same time, it's a less immunogenic vaccine, so we are confident of demonstrating robust immune response when we go head-to-head against PCV20 in our adult phase III program.
Great. Thanks, Kamal, and thank you, Graham. Just looking at the Q&A panel. Seamus, I just saw your hand up. Is that another question that you'd like to ask, or is that a hangover from the first round?
No, I can. Yeah, I'll just have 1 follow-up question on the pneumococcal vaccine. Just wanted to get a better sense of the number of serotypes that you're pursuing. I think you're talking about a 30-plus vaccine. It's our understanding that the target was somewhere between 33 and 36 as a possibility. I was just hoping if you could help us understand what the number of potential serotypes you believe is possible to pursue. Separately, just as an additional question, and then I'll drop my hand. The serotypes themselves are 1 piece of the puzzle, but can you also clarify if the technology is using novel proteins?
It's our understanding that this is not based on the CRM protein, but perhaps two novel proteins, and why that was done, and if you think that that is a potential advantage of this vaccine, or a potential risk from a regulatory perspective. Thanks.
Yeah. First, let me tackle the second question first. I think broadly, we're excited about the technology for three main reasons. Number one is ability to make high valency. You have seen the phase 2 clinical data with the 24-valent vaccine. I think for the first time, we have reversed the trend of declining immune response with increasing valency, and this will be followed by a 30-plus valent candidate going into phase 1 in 2024. Second thing is, the MAPS complex is highly immunogenic. We have seen strong antibody response against polysaccharides based on phase 2 data, and I would like to draw your attention to serotype 3, possibly one of the most challenging serotype to tackle with existing PCV technology. We have demonstrated 3-fold increase compared to PCV13, which is a more immunogenic vaccine compared to PCV20.
Third thing is, what's really unique is we are not using CRM197 as a carrier protein. Here we are using native pneumococcal protein, which is going to contribute to broad immune response, both T cell-mediated anti-protein immunity as well as B cell response towards this protein. We think that's possibly the X factor that could go on to have a potential impact on non-vaccine types and may contribute synergistically together with the higher polysaccharide response to tackle serotype 3. We feel confident that pneumococcal protein will show its benefit in the post-licensure space in further differentiating our candidate vaccine, both 24-valent, and we are adding additional pneumococcal proteins for the 30-plus formulation. We are not disclosing the composition of 30-plus formulation right now for competitive reasons. It's competitively sensitive information.
We are planning to enter the clinic in 2024, and you will hear more from us next year.
Thank you.
Great. Thank you, Kamal, and thank you, Seamus. Just gonna pause a moment, see if there are any more coming through. If not, I will loop back to Graham. In which case, Graham, back to you.
Great. Thanks. Yeah, if I can just follow up actually on MenABCWY, just talk through the different formulations that you're looking at across Europe and the U.S. on the different age cohorts, and just where you expect your products to fit in, and how you leverage having the pentavalent in that setting. Then just in terms of pneumococcal vaccine, I guess, you know, the original Prevenar seven was actually approved on a vaccine efficacy, and all these subsequent vaccines have been approved based on immunogenicity measures. Is there any discussion as to sort of how you can show an overall efficacy benefit, whether it be sort of some kind of total immunogenicity versus the existing vaccines that are out there?
Cause I guess one of the questions that comes up from KOLs and the recent ACIP meetings is, you know, are we actually just sort of diluting the immunogenicity against the existing strains to add them, but, you know, where's the net overall or aggregate benefit coming from? Is there a way to measure that you would think about targeting in a pivotal trial? Thank you.
Thanks for your excellent questions. I think you would have seen in our pipeline there are two menB-CWY candidates. The first candidate is a first generation menB-CWY, where we just announced phase III results. The candidate is built on the legacy of Bexsero, and together with the MENVEO, which covers ACWY strain. The immediate goal is to bring the vaccine to the US market as soon as possible via an advanced conversation with the regulatory authorities, with a target to file a menB-CWY candidate in the US in 2024. Soon after that, we intend to pursue licensure outside the US, targeting adolescents, then as part of lifecycle management, also to go down the age group to tackle the infant age group.
In addition to that, you would have seen we also have a second generation MenB-CWY candidate in our pipeline. Right now, that's in phase 2. As leaders in the field of meningococcal vaccines, we aim to stay on top of the evolving epidemiology. Our second generation candidate includes additional MenB components and aims to provide broader MenB coverage, and we will communicate more as we gather more data with the second generation candidate. For now, we are extremely pleased with the phase 3 results we have seen with our MenB-CWY results. It's the only vaccine that has demonstrated very high immunological effectiveness against a panel of 110 MenB strains, and we think MenB is going to be the key factor differentiating between products.
Coming back to your question about pneumococcal vaccine, as you would have seen, traditional placebo-controlled efficacy trials may not be feasible anymore, certainly not feasible in the pediatric population. The licensure is going to be via immune correlates, which has been well established for pneumococcal disease. That would be the primary pathway for licensure. The most important medical need is to expand the serotype coverage. That's the reason we are targeting 24-valent, which will provide disease coverage close to 60%, and then a 30-plus formulation will take it past the 90% disease coverage. In addition to that, we are discussing internally at this point in time, whether we should further supplement the program with pre-licensure trials to seek additional indications, and we will disclose more details as we get closer to the phase III start.
Super. Thank you, Kumaran. Conscious we're just up against time, but I'm mindful. Are there any final quick questions, perhaps for Rob around the anti-infective space? If not, we will close the call before quickly informing you how to get to the next session. Is that a quick one, Graham, or is that a hangover from before?
Oh, sorry, then I left my hand up.
No, that's cool. No problem at all. Thank you. In which case, thank you very much, everyone, for joining this session. You now have approximately 15 minutes to join the next virtual breakout, which starts at 3:15 BST. Details are available on the Zoom events landing page that you used to get to this one or via the email you received. All presentation and event recordings from each breakout session will be available on gsk.com at a later date. Thank you. Thank you very much to our panelists, and thank you for your interest in GSK. Enjoy the rest of the sessions. Thank you very much.
Viral infection in more than 300 million people globally. Finally, herpes simplex virus, a lifelong incurable infection responsible for genital herpes. It is my pleasure to introduce Lizzie Champion, who will provide an overview of Shingrix and the exciting future of this important vaccine.
Great. Thanks very much, Chris. I'm delighted to be here. It goes without saying that Shingrix is absolutely a flagship vaccine in our portfolio. If I start with just the vaccine itself over on the left of the screen, unprecedented in terms of efficacy, delivers and duration of protection. 97% efficacy in pivotal clinical trials, and that efficacy we know now sustains at more than 80% over 10 years and counting. If I talk next to performance to date, we're 5 years post Shingrix launch, and Shingrix has already grown to be a 3 billion GBP product.
Much of the success we've seen to date has been in the U.S., already of the 120 million Americans eligible to receive Shingrix, we've penetrated to around 30% of that figure, leaving around 85 million Americans still unvaccinated and remaining eligible for Shingrix. Ex-U.S., we have accelerated very fast. You can see on the screen that we've now, as of today, launched in 31 markets, well on track to be in 35 by 2024, those 31 markets represent just around 90% of global vaccines market by value. Unconstrained on supply, this geographic expansion, you can see from the chart, is starting to deliver significant growth. As of 2022, last year, ex-U.S. was over 30% of our revenue and more than 50% of global Shingrix growth.
Looking ahead now, we are firmly on track to deliver the commitment to double Shingrix sales, reaching GBP 4 billion by 2026, and we expect Shingrix to be a multi-billion GBP product through the decade. On the right, I wanted to give some flavor of some of the opportunities we're looking at for continued expansion of Shingrix. I'll start with population expansion. We already have a very broad label with Shingrix, but there's opportunity to go broader. A good example of this, a recent example, was only this week, you may have seen, we've announced an expanded indication for Shingrix in Japan to prevent shingles in adults 18 and over who are at increased risk. That's, that's a build of a new segment, 18-49 year olds at increased risk in Japan.
Beyond that, another cohort that I wanted to talk about is healthy people under 50. We know there are significant numbers of shingles cases in the 40-49 cohort. This cohort in the U.S. alone, represents around 40 million people, and in that cohort, we know there are more than around 100,000 shingles cases per year, so there is an unmet need. With the duration of protection that Shingrix has demonstrated, which is shown on the left of the chart, we're able now to consider the benefits of vaccination in this younger group. At the moment, we're focused on better categorizing the burden of disease and public health impact in this group, to then initiate discussions with regulators and public health bodies. Second, I'm going to talk briefly about booster.
Again, referencing the chart on the left, you can see the sustained protection, at over 80%, that Shingrix delivers up to 10 years so far. What you can see on the chart is there is some very limited waning of efficacy to date, so of course, we are considering the need for a booster. The one thing I would say there is, it's reasonable to assume that not all populations will have the same need for a booster. We know it's early still, but descriptive data in immunocompromised patients, which we reckon is about 10% of our total patient pool, shows some breakthroughs earlier than 10 years. This group, we believe, will be the first to benefit from a booster rechallenge.
What's important to say is that we continue to track the long-term data, and that data will be what informs the need for a booster and in which populations. Third, I wanted to talk about some very interesting emerging science linked to shingles vaccination. Some of you may have seen there's a growing body of evidence which suggests shingles vaccination is associated with a reduction in the risk of dementia. This includes a particularly interesting recent observational study. I want to note that the study is not yet peer-reviewed, but it has gained significant attention, so I'm sure some of you will have seen it, which shows a 19% reduction in the risk of dementia following shingles vaccination. It's emerging science, and there remain significant unanswered questions as to what underpins this potential association.
Of course, it goes without saying that any risk reduction here is incredibly meaningful and therefore a reason for us to be excited and put focus. I'll now hand back to Chris, who'll share more about the science we've seen on chronic hepatitis B, herpes zoster, and herpes simplex. Over to you, Chris.
Thank you, Lizzie. Next slide, please. Chronic hepatitis B, a viral infection of the liver, is associated with both acute and chronic liver injury and disease. When the immune system is unable to clear the virus, the virus actually is harbored in the liver and can be detected in the blood. There are approximately, as you can see on the left, 300 million people with chronic hepatitis B, and it results in nearly 900,000 related deaths, and those deaths are typically due to liver failure, advancing cirrhosis, and liver cancer. All patients living with hepatitis B need to be regularly monitored because they're at increased risk of developing long-term liver sequelae, even if at the time they are feeling well. The desired goal of treatment is something called functional cure.
That's clearance of both hepatitis B surface antigen and hepatitis B viral DNA from the blood after being off all therapies for at least 6 months and longer. Therefore, to be a successful treatment, not only do you have to suppress HB DNA, you also have to help seroclear hepatitis B surface antigen, which in turn enables the body's own immune system to clear the virus. Current treatments include nucleoside or nucleotide analogs, which I'll refer to as NAs moving forward, and immune therapy, specifically pegylated interferon or peg interferon. Despite these therapies, very few patients attain functional cure. On average, treatment with NAs typically result in functional cure rates of less than 2%. More importantly, patients on NAs usually require lifelong therapy because when treatment is stopped, most patients rebound.
The ability to achieve functional cure when peg interferon is added to the regimen increases functional cure rates, but comes with significant systemic side effects, making it difficult for patients to complete 48 weeks of therapy. In fact, about a third of patients are unable to complete a full course of treatment. Hence, better treatments are needed for patients given the unmet need. Chronic hepatitis B infection remains a global public health issue, and diagnosis remains low. In the US, it's estimated that only about 35% of infections are diagnosed and only about 25% in Europe. In Japan, those rates are about double, but they also mandate screening of the virus.
This past year, the CDC published guidelines that suggest that adults should be tested for hepatitis B. This was to raise awareness both about the disease and to increase diagnosis rates given the long-term sequelae. As part of our continued mission to get ahead of disease and develop innovative medicines to treat more than 2.5 billion people, GSK is committed to finding a functional cure for hepatitis B to complement our prophylactic hepatitis B vaccine. We are excited to discuss bepirovirsen or bepi, a new agent that could advance the treatment of chronic hepatitis B, potentially providing functional cure for patients. Bepi is an antisense oligonucleotide that was designed to inhibit translation of hepatitis B viral proteins from its messenger RNA. Based on our evolving data, bepi distinguishes itself from other investigational therapies by its unique triple mechanism of action.
It inhibits production of viral proteins, including hepatitis B surface antigen. It reduces viral replication as measured by reducing hepatitis B DNA, and it stimulates the body's innate immune system to suppress the virus. It is this unique triple mechanism that we believe offers the potential for bepi to change the treatment paradigm in chronic hepatitis B by potentially offering patients functional cure. Next slide, please. Last November, data from the phase 2 B-Clear trial was published in the New England Journal of Medicine.
The study demonstrated that at the end of study period, 9%-10% of patients on a background of nucleosides and not on a background of nucleosides, were able to achieve sustained loss of both Hepatitis B surface antigen and Hepatitis B viral DNA following 300 milligrams of bepi for 24 weeks, and then followed for an additional 24 weeks off of their therapy unless the patients were on NAs. For patients with antigen levels of 3,000 and below at study entry, 12% of patients receiving NAs and 25% of patients not receiving NAs met the conditions for functional cure. In patients with the lowest surface antigen levels, less than 1,000 at baseline, bepi resulted in even stronger response rates of 16% for the NA treated group, and again, 25% for those not on NAs.
The B-Clear study helped us identify the patient population most likely to achieve functional cure, those patients with a baseline surface antigen of less than 3,000, and this helped us inform the design of our phase III pivotal B-Well studies, which are actively enrolling patients. The B-Clear data also demonstrated that bepi, in combination with other therapies, will be needed to treat patients with hepatitis B surface antigen levels at baseline greater than 3,000. Specifically, sequential combination therapy to further reduce baseline HB surface antigen levels prior to treatment with bepi and potential immunotherapies after bepi therapy to augment bepi's stimulation of the innate immune system need to be tested in patients where baseline hepatitis B surface antigen levels are greater than 3,000. Later this year, data from B-Together, our sequential combination therapy using bepi followed by interferon, will be available.
This study will help inform the design of future immune therapy combination studies. Next slide, please. Now I'd like to switch to our last chronic viral illness, herpes simplex virus. After chronic viral infections that impact patients globally, another one is the herpes simplex virus, responsible for genital herpes. GSK1104 is a novel therapeutic intervention in early development for genital herpes, and it leverages the knowledge and experience gained from our work with herpes zoster virus, VZV. Both HSV and VZV are alpha herpes viruses that lead to lifelong latent infection in neuronal ganglia following initial infections. HSV and VZV evolved mechanisms that enable these viruses to evade detection by the body's immune system. GSK is building on our internal expertise, knowledge, and experience with Shingrix as we commence early development of GSK1104.
Around 500 million people across the world are infected with herpes simplex virus. One-third of the patients with genital herpes suffer frequent outbreaks. Beyond the physical outbreaks, genital herpes is also associated with significant psychological morbidity, stigma, low quality of life, and a threefold risk of acquiring HIV. Genital herpes is incurable. Antiviral therapy is the only treatment option available. Antiviral medicines, however, have a modest impact on outbreaks and on transmission rates. Although GSK 104 is still early in its development, we are excited about the potential for this asset. With that, I'd like to hand it over to James Greenough to wrap up on our commercial commitments to growth.
Thanks, Chris. We're looking forward to the opportunities we have for our chronic viral infection assets in terms of the future of Shingrix, the opportunity we see for bepi, and the early excitement we have for the HSV assets. On Shingrix, we're well on our way to doubling Shingrix revenue by 2026. We'll be in 35 markets by 2024 and are exploring lifecycle management opportunities. On bepi, we believe our potential functional cure for chronic hepatitis B has potential peak year sales of more than GBP 2 billion. We remain excited about the promise of bepi as a potential cornerstone therapy. Finally, while it's too early to make firm commercial commitments, we're very excited about the potential Chris highlighted for GSK1104 in genital herpes. With that, we'll move to the discussion, and I'll hand back to Mick to moderate the Q&A.
Thanks, James. Now we'll go to Q&A. As a reminder, to ask a question in Zoom, please raise your hand using the icon in the menu bar, and then I will open your line so that you can ask the question. If you've joined using a telephone number, please press star 9 to register a question and star 6 to unmute if required. Please, could you limit your questions to 1 to be fair to all participants? We'll open up. I can see, we have a question from Emmanuel. Emmanuel, hopefully, you should be able to speak.
I have indeed unmuted myself, sir. Thank you for taking the question. You limited me to one, it's difficult, but, the bepirovirsen, I mean, maybe talk to us a little bit about expectation for the functional cure you're hoping to see in the B-Together data with interferon later this year. Maybe I could tag on a second part, which is, what do you think is the threshold for functional cure rates we need to see or should want to see to drive broad clinical adoption, should this drug become available to patients in due course? Thank you.
Mick. Tony, go ahead.
Yeah, Mick, if you're. Are you gonna coordinate, or do you want? Why don't I make a start, Chris, and then perhaps you can, you can embellish on that. Good to hear from you, Emmanuel. Look, the way to think about this with regards to the overall study is we're running a number of Phase 2 programs, of which B-Clear is one, B-Together is a second, which are really designed to inform the proposition then for more in-depth Phase 3 analysis. B-Clear, to Chris's point earlier, has already established the likely response characteristics to patients on monotherapy.
As I indicated in the introductory session, if you were available to join it, our estimate there, based on modeling, is that we'd expect to see around about a 20% functional cure rate, which we think is clinically significant. B-Together itself is running another experiment, which is asking an important question as to whether or not the addition of interferon on top of Bepi in sequential form is capable of preserving the depth of response that we see at end of therapy. If you look at individual data for interferon itself, you'll see that although functional cure rates there are typically in the order of 5% or less, higher rates can be achieved, but what you have is a significant degree of discontinuation associated with the side effect profile for interferon.
What we're trying to do in B-Together is simply to assess how that might fit in the context of the overall clinical plan. The important thing, though, I would emphasize at this point, is it's one of a number of phase II studies, and we really see those together with prosecuting Bepi B-Well i n the B-Well phase III setting as being the earliest point at which we will then underwrite a phase III data confidence level set for Bepis and monotherapy. Chris, if you want to add anything to that, please do.
Tony, just to highlight one other point. If you look at the B-Together, the treatment course of interferon is not the typical 48-week treatment course. It's sequential 24-week. That's because everyone we talk to, both in terms of patients as well as the investigators and physician communities that treat these patients will tell you the systemic side effects of interferon are significant. As we look to the future and we look for future immunotherapies, getting an understanding of what an interferon treatment course can do really helps to unlock many of the other potential ways that we would want to augment the immune response that Beppy initially triggers as a way to cure disease.
I think it's really important to put this in the context of what we see in terms of functional cure rates currently based on standard of care.
Thank you.
Emmanuel, my own build would be, we see clinically meaningful from both physicians and payer researchers being, from 15%-20% and upwards. Very excited at those points.
Thank you.
Emmanuel, does that answer your question?
It does. If I'm allowed one very quick follow-on, the only question would be the 15%-20%. Are you talking about that at the end of the treatment period or, you know, 6-12 months post cessation of treatment? Obviously, in the studies we've seen so far, there's been a significant drop over that time period.
To me, Emmanuel, that's functional cure rates.
Chris, you might comment on our modeling and projection, so we can just join the dots for Emmanuel.
Sure. In order to t his is to help clarify, functional cure requires at least 6 months off of all therapies. As if you start to look at the B-Clear data that we just showed, that was after the bepi had been discontinued for 24 weeks. Now, we have to keep in mind that there was a cohort that were on nucleosides and nucleotides, but there was also a cohort that had not been on those at baseline that were followed. There, again, when you see, based on the cuts of hepatitis B surface antigen, you had in the non-nucleoside group, response rates at the end of that period of 25%.
Thank you.
Excellent. If we have any other questions, please feel free to raise your hand. One question that we had received, because obviously there's the email. My email address is also at the bottom of the invite. I mean, I guess this one would be more for Lizzie. Thinking about Shingrix opportunities over the medium term and what can continue to drive growth for Shingrix.
Yeah. Thanks for the question, whoever emailed. I think let me start by restating our confidence in Shingrix over the medium term. I'll replay some of the messages that I stated in the presentation, which is this year, double-digit growth, confident to double our revenue to GBP 4 billion by 2026, and we expect multibillion products through to the end of the decade. Why do I say that? Let me touch on three points. Starting with the U.S., there is huge headroom remaining in the U.S. 85 million Americans remain unvaccinated. Clearly, we've reached 30% of the 120 million Americans, so we've reached, again, easy to reach the motivated people, the people who were first in to their HCP to receive the vaccine.
We are absolutely confident to reach the analogs that we have with flu, with pneumococcal disease, all adult vaccines, which would take us to 60%. We are a long, long way of saturation in the U.S. The other thing I'd say, just to remember from a U.S. point of view, which I think people often forget, is that even at the point at which we've saturated the full catch-up cohort, there are 4 million Americans who will enter the cohort every year, which is a really significant number, and I think often under-recognized. That's the U.S., huge headroom. Ex-U.S., I would say we're really just getting going. I think you all know that our focus to date has really been U.S., with mostly private market, ex-U.S., and we have huge potential to expand from that private market.
Really to build on the momentum we've demonstrated with the more than 30% of revenue in 2022 and continue to expand access to Shingrix through national immunization programs. I just want to share one very specific example. I already shared a Japan example, but a different Japan example. Japan is obviously a very, very important market for us. As of April this year, in the Tokyo area, which represents by far the biggest, you all know, by far the biggest city in Japan. 6 million patients over the age of 50, they were all granted a subsidy, which means they get reduced cost access to Shingrix, and of course, with that, we expect tailwinds in Japan. It's early days, but those are examples of some of the expansion we expect.
The last thing I would say, and I won't go into more detail because I showed this earlier, but we are looking for further expansion opportunities. With booster, with population expansion, we expect to continue to be able to deliver growth with Shingrix over the medium term.
Thanks, Lizzie. Our next question comes from Tim Anderson. Tim, hopefully, your line should be unmuted.
Yeah. Can you hear me?
Yes.
Great. When will the China opportunity materialize meaningfully with Shingrix? On the guidance for GBP 4 billion by 2026, or greater than GBP 4 billion. Consensus is already at GBP 4 billion in 2024. I'm trying to understand why. It seems like that guidance by 2026 is, you know, quite conservative. The product did GBP 3 billion last year, on its way to GBP 4 billion this year. Consensus has GBP 4.3 billion in 2024. You're saying it won't get there until 2026. Can you explain? Thank you.
Let me start with China, and that will be I guess part of the answer will be ex-US. China, what I would say is, it's really very early days. If you think about the COVID impact, China are now exiting the impact of COVID. We are very excited about the opportunity in China. I won't state the numbers, but I think you only have to look at some of the other private vaccines available in China to see the opportunity that we have ahead of us, and we are absolutely poised to move on that opportunity. As of today, we're present in around 300 cities, which represent more than 80% of the addressable population we see for Shingrix. Very excited about the opportunity we have ahead in China.
In terms of your question about cautious, I think was your question. Let me restate. We have said confident to double revenue, reach GBP 4 billion by 2026. There are multiple components to that, driven out of U.S. sales, and as I've said, you know, we see continued growth in the U.S., but clearly, the art of the U.S. means that as we continue to penetrate the 120 million Americans, it becomes harder to get there. We are far, far, far off saturation, but we expect to see that shape of the curve in the U.S. Ex-U.S., I'll restate, tremendously important looking forward, it will increasingly become a key part of our delivery.
I think we stated Q1, close to 30%-40% of our revenue in Q1 this year, and that will continue to grow as we look ahead. I'll restate, expect this to be a multi-billion GBP product through the decade.
Excellent. Our next and perhaps final question, will be from Michael Leuchten . Michael, can you, if you unmute.
Yep. Thanks, Mick. Hope my headset doesn't hack in. Very quick question on the booster strategy for Shingrix. Just wondering what the regulatory burden or ask may or may not be, given the longevity of the vaccine data. Like, how do you do a study that would sort of show the booster benefit, given you've got the 10-year efficacy data of up to 90%?
Yeah, it's a great question, Michael. The way we're thinking about this, and again, I'm going to restate some of the stuff I've said, but we think it's highly likely that the booster strategy won't be consistent across all patients. We know that we're seeing some differences in terms of immunocompromised patients. That could be somewhere around 10% of our patient pool, but if we see an increased waning in a broader group than that, so an increased risk patient group, then, of course, that number becomes bigger. We are yet to engage with regulators on this. It's important to state that. Actually, as of yet, we are waiting for the data to further inform. We continue to track through long-term follow-up. We have the 10-year data, as you stated.
As of next year, we have 12-year data available, and that will inform how we then engage with regulators and in terms of the positioning for booster. The main point I think that's important to take away is that you shouldn't think about all patients as the same. We believe that we will be able to find a route through which doesn't require us to follow an efficacy study that will get us there to a booster within an appropriate time frame. I would say the last comment is, remember that we are five years post-launch. Despite the fact we have 10 years of long-term follow-up data, we're still quite early. We have a runway ahead of us to bring booster through.
Lizzie, you might also just comment as well as that, which I fully agree with, but we also need to understand the nature of breakthrough as well within that population, which is, again, Michael, yet to be properly qualified. Lizzie, do you want to just finish off on that?
Yeah. Tony, what you're referencing is the long-term data so far. What we need to understand better is just the severity of those breakthroughs. At the moment, we're seeing numbers of breakthroughs, but what will become important to further categorize the need for bolstering in which populations is the severity of the breakthroughs and how they show up.
Excellent. I guess we may have time for one further question if somebody would want to raise their hand. Well, I can see. Is that Emmanuel? You can unmute and fire away.
Thanks. Maybe just to follow up on peak penetration levels you expect to achieve in the US, given your comments around, 30% penetration and $85 million remaining, how far realistically, do you expect to get into that?
Yeah.
At what point do you think you've reached a tipping point whereby you've, it starts to slow down significantly in terms of penetrating that catch-up cohort? Thank you.
Thanks for the question, Emmanuel. I think I referenced, if we look at other adult vaccination analogues, I want to state flu, pneumococcal, all are significantly north of 60%. We remain absolutely confident that we will get to the 60% penetration. You know, from the 30, I think we're actually somewhat a little bit north of 30 now, but confident that we'll get from 30 to north of 60% penetration.
I think we may have time for one more. Tim, did you have another question?
Yes. On bepirovirsen in all comers, it didn't make a difference when you added a Nuke or not. In Nuke naive versus Nuke-treated patients, you had functional cure rates that were about the same, 9%-10%. I'm wondering why that would be the case. I know that by certain subgroups within that, you had higher response rates, why in all comers would it not really make a difference to have Nuke as background? Thank you.
Thanks for the question, Tim. It gets to the fact that NAs don't clear surface antigen. What we have seen is that for Bepi, the best responses are those patients with surface antigens at baseline 3,000 and below, which gets to our discussion about why we believe to get those patients with surface antigen levels above that at baseline, we're going to need to talk about combination therapy. It is important to note what the NAs do is suppress DNA, but have no impact on surface antigen.
I see. Thank you.
Excellent. oh, did I see one further question? No, I think so. Hopefully, you've now got about sort of 10 minutes to join the next breakout session. Hopefully, you have details for that on the landing page. I'd like to thank each of our panelists and for everybody who's dialed in for this session. Thank you very much, and thanks for your interest in GSK, and you can now please disconnect. Thank you very much.
Hello, everyone. Welcome to this breakout session focused on delivering health impact at scale. I'm Frannie DeFranco from the Investor Relations team, and today I'm joined by Deborah Waterhouse, CEO of ViiV Healthcare and President of Global Health at GSK, and Dr. Thomas Breuer, Chief Global Health Officer. Here is our usual safe harbor statement. The purpose of this session is to provide you with an overview of our work to deliver health impact at scale. Deborah will give you a short presentation, and as always, we'll have plenty of time for you to ask questions, at which point she'll be joined by Thomas. With that, I'll hand it over to Deborah.
Thanks, Frannie. As a global biopharma company, we know that our ESG strategy supports our sustainable performance and long-term growth. Specifically, we see the S as an area of global leadership for GSK, with our proven expertise in prevention and infectious diseases. This is why we laid out our bold ambition to positively impact the health of more than 2.5 billion people worldwide, including more than 1.3 billion people in lower-income countries that are often disproportionately affected by infectious diseases. Why last year, we announced an investment of GBP 1 billion over the next 10 years to accelerate R&D, led out of global health research hubs in Siena and Tres Cantos, dedicated to infectious diseases that disproportionately impact lower-income countries.
Alongside this work, we also develop access and equity strategies across our commercial pipeline for vaccines and medicines that target priority diseases most relevant to global health. As Emma has said, we are focused on getting ahead of disease together by using our science, technology, talent, and partnerships to deliver health impact, reducing the global health burden, whilst also contributing to the sustainability of GSK, something that I will talk about over the next few slides. One of the important benefits of being a global company is the ability to reach people at enormous scale, and I'll expand on just a few examples of how we do this. Earlier this year, through our immunization partnerships, we reached a milestone of 1 billion vaccine doses to Gavi, contributing to the expansion of immunization programs in low-income countries.
The WHO states that after clean water, vaccination is the single most effective public health intervention in the world, and by working with partners like Gavi, we can expand sustainable access and strengthen healthcare systems. We're also passionate about the impact that we can have on neglected tropical diseases or NTDs, and the disproportionate burden they have on some of the world's poorest communities. We remain committed to the elimination of lymphatic filariasis globally, and our albendazole, our albendazole donation program has supplied more than 11 billion tablets, driving the elimination of LF in more than 18 countries. The way in which we leverage partnerships is also evident in our work in ViiV. Today, approximately 38 million people living with HIV, the vast majority in sub-Saharan Africa, where many people live on $1 or $2 a day.
We are proud of our long-standing partnerships with the Medicines Patent Pool, have agreed the most comprehensive set of voluntary licenses of any company for our antiretroviral dolutegravir. As a result of these licenses, around 21 million people, representing just over 80% of people living with HIV across 122 low and middle-income countries, have access to generic formulations of dolutegravir-based medicine. In parallel to delivering significant impact for underserved people in low-income countries, our work creates tangible opportunities to create value across GSK. Let me share some examples of how we do well by doing good to highlight this.
The platform technologies developed as part of our global health R&D have in turn supported the development and commercialization of other assets in our pipeline, specifically the AS01 adjuvant, which was the result of our malaria vaccine R&D, and that is now used in Shingrix and Arexvy. Through the FDA's priority review scheme, the approval of tafenoquine, our medicine for radical cure of P. vivax malaria, unlocked a priority review voucher that enabled us to bring forward the commercial launch of a V product in the US by six months. Our investment in pediatric reformulations of dolutegravir supported the extension of our dolutegravir patent protection by six months, and I can announce today that dolutegravir has been granted pediatric exclusivity by the FDA, extending the patent to 2028 in the US. We will follow the same approach for cabotegravir.
Back to the point I made earlier about the scale of our impact, supplying large volumes of vaccines through partners like Gavi provides efficiencies in manufacturing, which lowers overall cost of goods. Over the next few slides, I'm going to walk you through some of the programs we are working on today that we believe will deliver significant health impact. In many resource-poor settings, the greatest barrier to treating and preventing HIV remains access to affordable medicines. Within 6 months of Apretude, cabotegravir long-acting for HIV pre-exposure prophylaxis or PrEP, being launched in the U.S., we were proud to announce a new agreement with the Medicines Patent Pool, granting voluntary licenses for this innovative long-acting prevention medicine. In March this year, sublicenses were signed with 3 generic manufacturers who will help enable access across 90 countries.
It's also important that we don't leave behind those who are living with HIV. As we know, HIV disproportionately impacts some of the most vulnerable populations, including 1.7 million children, 99% of whom reside in low and lower middle-income countries. In response, we've created dissolvable formulations of our key medicine, dolutegravir, increasing usability and accessibility for children and their caregivers. We are delighted that around half of children now on treatment are taking a generic version of our dispersible formulation of dolutegravir. Looking to the future, we are committed to developing new and innovative age-appropriate formulations of our medicines for children, including our long-acting injectable products. Another example I want to share with you is our work in malaria.
Malaria is a disease which continues to take the life of a child under the age of 5 every minute in sub-Saharan Africa. With our partners, we've developed two products for the prevention and treatment of malaria: the world's first vaccine against malaria, Mosquirix, and a single-dose radical cure for P. vivax malaria, tafenoquine, which is due to be rolled out this year. Mosquirix is pre-qualified by the WHO, a prerequisite for UN agencies such as UNICEF, to procure a vaccine, and through the Malaria Vaccine Implementation Program in Ghana, Kenya, and Malawi, nearly 1.4 million children have already received at least one dose of this vaccine, and this rollout continues. To secure long-term supply and reach even more children in malaria-endemic areas, a tech transfer is underway with Bharat Biotech of India.
The acceleration of this tech transfer will significantly increase production output of the vaccine, with GSK continuing to supply the AS01 adjuvant to Bharat. This tech transfer illustrates our model of sharing the responsibility of bringing innovative medicines and vaccines to patients. Taking this approach ensures GSK can focus on new developments of innovative candidates. Finally, I'd like to talk about tuberculosis. TB should be preventable and curable, yet it is the second leading infectious disease killer after COVID-19. In TB prevention, we have delivered proof of concept of the M72/AS01E vaccine, which demonstrated significant efficacy in a phase 2b trial. The results were described by the WHO as unprecedented in decades of TB research, vaccine research, and an important scientific breakthrough.
M72/AS01 could become the first new vaccine to protect against tuberculosis in more than 100 years, and the first to show significant efficacy in adolescents and adults. The Bill & Melinda Gates Medical Research Institute, Gates MRI, obtained a non-exclusive license from GSK for continued development of this vaccine for low and lower middle-income countries, and now has the primary responsibility for the ongoing development, including the phase III efficacy study. Importantly, this license does not impede GSK's ability to commercialize the vaccine in upper middle and high-income countries, including China, where TB remains a public health concern. Beyond our vaccines, we aim to change the treatment paradigm in TB and tackle the growing issue of antimicrobial resistance. Since current treatment options can have serious negative impacts on patients' lives, we are developing in partnership with several potential.
We are developing in partnership, several potential first-in-class medicines for shorter and simpler treatments. There remains a need for multi-drug regimens, which means collaboration is essential to get ahead of TB, and we are industry leaders in multiple multi-sector research consortia to advance their development. Before I close, I'd like to emphasize how proud we are to prioritize our commitment to getting ahead of infectious diseases that disproportionately impact lower-income countries. Our work in this space has been recognized by the Access to Medicine Index, which has ranked us as the number one since the index's inception in 2008. We are very proud to be leaders in this space, and we know that our employees are proud, too.
In fact, in 2022, our annual company-wide survey showed that our long-standing commitment to global health contributes to why colleagues feel proud to be part of the GSK organization, with the vast majority of colleagues believing that GSK is ambitious for patients, and GSK is committed to making its products affordable and available to people around the world. With that, I will wrap up the presentation and pass back to Frannie for Q&A. Thank you.
Thank you, Deborah. We will now go to Q&A. As a reminder, to ask a question in Zoom, please raise your hand using the icon in the menu bar. I will then open your line so you can ask a question. If you've joined Zoom using the telephone numbers provided, press star nine to register and ask a question, and star six to unmute if needed. Can I please remind everyone to limit the questions to one to be fair to all participants? Thank you in advance. I will now stop sharing my screen so that I can see any participants that may have a question. Again, just use the raise hand function and I will come to you. Or if you prefer, I'm happy to receive emails. It's just my name, frances.p.defranco@gsk.com. That's easier. I know sometimes people are uncomfortable coming off mute.
If we have any questions, we'd love to take them. Let me just look in my emails. Okay, great. It looks like we do have one that's come through. Thomas, thank you for coming on video. This question is actually for you. It says, "We see that we have the Chief Global Health Officer here with us as well. Would love to hear a little bit about his role and how he's approaching global health." Let's come to you, Thomas, to give some background there.
Yeah, thank you. As part of our ESG agenda to reduce health inequality in low- and low-middle-income countries, focusing on infectious diseases, we essentially have a three-pronged approach. We have a group of roughly 200 people exclusively focusing on global health. We have two R&D units, one in Spain, one in Italy. One is exclusively focusing on developing new medicines, malaria medicines, TB medicines against neglected tropical diseases. On the other side, we have a similar unit in Italy, which exclusively focuses on developing new vaccines, again, strictly speaking, on global health vaccines. That is R&D. We have another group, which is access. This unit is accountable for products GSK owns and has in the market to make them accessible to low- and low-middle-income countries. Examples are the Gavi vaccines.
Numbers were mentioned by Deborah. We have a huge albendazole donation program against NTDs. This is access. The new malaria vaccine falls into this category as well. We have a smaller unit which works on capacity and capability projects mainly in Africa, but also in other countries. We work, for example, with Save the Children or AMREF, another organization where we focus on TB. Maybe another point Deborah briefly alluded to this. Obviously, we want to do good in developing countries because it's part of social responsibility, and we are very strong in this. Sometimes it happens that what we do in global health has impact on our commercial side.
An example is that the adjuvant AS01 was first tested in malaria trials, and the same adjuvant is now in Shingrix on our recently approved RSV vaccine. When you provide vaccines in high-income countries, if you have high volumes for low-income countries, your overall economics of scale goes up and the cost of goods for all vaccines essentially go down. We have the FDA vouchers for global health, medicines, and vaccines. Tafenoquine is a good example where we got the voucher. The voucher was used by ViiV to get a HIV product on the market in the U.S. six months ahead of time. There are interlinks between what we do in global health on the SG agenda and commercial activities.
Thank you, Thomas. That was very helpful. I had a second question that's come in around MPP agreements. How does data get collected around reach for MPP agreements? This is a Medicines Patent Pool for everyone-
Yeah.
Who's listening. Who is responsible for this? How is it happening? I think a little bit about tracking and responsibility once it goes with MPP.
I can answer that one because it's more in the HIV space. We've had a long-standing relationship with the Medicines Patent Pool, both on dolutegravir and now on cabotegravir. What happens is we issue kind of voluntary licenses, a vast majority of which are royalty-free, and the MPP then awards those licenses to generic manufacturers. They are responsible for tracking then the number of people in lower middle-income and low-income countries that actually receive those medicines. We talk about the fact that of the 28 million people globally that are on an antiretroviral, 21 million are in least developed countries on a dolutegravir-based regimen, and that data comes from the MPP. It's fully verified by them, and then we're able to publicly share that.
We've got an incredible partnership with the MPP. At the moment, we're all working very hard on ensuring that cabotegravir PrEP, which could really change the trajectory of the HIV epidemic in sub-Saharan Africa. We're working very hard through the MPP to ensure that the generic manufacturers that have been selected, that the tech transfer goes fast and smooth, and that we're able to release significant volumes of products from those generic manufacturers into the marketplace as quickly as we can. There's likely to be a two- or three-year gap.
We've made a commitment that at a not-for-profit price, we will bridge between now and when the generics come on stream. Again, MPP awarded those voluntary licenses, which are royalty-free, and then they will track how many people benefit from cabotegravir for PrEP. That's how it works.
That's very helpful. Thank you. I do see a number of people on the line that I know your names, and I know that you're not shy. While I'm happy to receive emails, we'd also love the interaction. If anyone in this session does want to raise their hand, I'd be happy to come to you. I know there are some vocal investors that are here. If not, I have one that I think would be helpful for us to sort of give an overview of how our approach to global health ties in with ESG in general. Deborah, I think this will come to you, but can you talk about GSK's approach to ESG and some of the things that you've talked about in the global health space and how it connects from a health impact and business perspective?
Yeah. ESG for GSK broadly is an integral part of our strategy. If we want to attract investment, if we want to demonstrate that we are a company that has a long-term, sustainable future, we believe we have to do well financially, obviously, but it's also important to be responsible from a doing good perspective. We ensure that we have six kind of key areas that we focus on: access to healthcare, global health and health security, environment, diversity, equity, and inclusion, ethical standards, and product governance. We basically weave those areas into how we run our business every day.
The work that we do, from a health impact perspective, both through ViiV and through GSK's global health, is a real contributor to the social part of that agenda, which is in the main around access to healthcare, but also about global health and health security. A lot of what we've talked about today, Thomas has given great examples of where our medicines and our vaccines are having, you know, huge impact, you know, in many lower and low middle-income countries. At a macro level, the way we talk about this is that we say, by 2030, we will have impacted the health of 2.5 billion people around the world.
GBP 1.2 billion will be through the work we do in our commercial markets. GBP 1.3 billion will be through all of the work we do through Global Health and the work that ViiV does with the MPP, et cetera. That will reach GBP 1.3 billion. That really sets us apart, I think, from, you know, from many other companies because we're very, very explicit about the goal that we're aiming for. We're very, very clear that it's an integrated part of our strategy overall in delivering against that ESG agenda. I think investors, you know, really respond well to that because you want to have a company that's, you know, financially successful, giving a good return, but is going to be sustainable over the long term.
That is obviously where the ESG part comes in. We're very focused on it's an integral part to how we run our business, our goal is to reach 2.5 billion people in terms of impacting their health over the next 10 years.
Okay, that's great. Neil, I see that you have a question. I'm going to allow you to talk, and hopefully, you can come off mute, and ask your question.
Oh, hi. Can you hear me?
Yes, we can.
Yeah, I just, obviously, it's great to see GSK making so much progress. In terms of the clinical trials, obviously, you need a number of volunteers to try out these new drugs. Is that possible to get that number going forward? Because I think you're struggling at the moment, aren't you, to recruit?
I could give an answer for HIV, and then I'll pass to you, Thomas, to talk about global health more broadly. When we undertake our global health, our HIV clinical trials, we have a large global footprint. We make sure that we represent all the populations across the world that are, you know, either living with HIV or have the potential to acquire HIV, depending on what sort of study it is. We find that those studies recruit fairly rapidly, particularly as we work, you know, often with partners. I'll give you an example of the HPTN 083 and 084 studies that we did for HIV.
The women's study, which was around 3,000 women, who were at risk of acquiring HIV, was totally done in Sub-Saharan Africa. It recruited quickly, and we had, you know, quite, you know, profound results from that study. As you know, it came out as superior versus standard of care. In HIV, actually, in all settings that we operate, we find that we're able to recruit relatively rapidly, despite the fact that we're very specific, that the people who we enroll in the trials must be diverse and representative of those people who are living with HIV or at risk of acquiring HIV. Thomas, do you want to talk about some of the studies that we've got ongoing in global health?
I cannot spontaneously give you an overall number, but we have a few, around 6 clinical trials ongoing on the vaccines and the medicine side. They're in phase 1 and 2, recruitment is in the hundreds. There's no problem recruiting patients. Because these vaccines and medicines will ultimately be used outside Europe and in the U.S., we have to test these vaccines in countries where they will be used in the future. Before these trials start, we have to invest in facilities, making sure the right investors are approached. That is slightly different from global health. When you go into phase 3 trials, especially on the vaccine side, the trials are rather large.
If I use the latest example of the TB trial, which will be done in collaboration with the Gates Medical Research Institute, it's a trial of 26,000 patients. These are big trials, but recruitment is usually fairly well organized, and I don't anticipate any problems there.
That's very helpful. This is a nice time, I think, to plug that we did an investor education event about clinical trial diversity and the importance of that. Dr. Kimberly Smith from the View organization, and then also our head of clinical studies, who was really fantastic, Alberto Fernandez. That's on our website. We've had another question come in around the Access to Medicine Index. GSK is ranked number one for a number of years. How are you going to retain this position? What is the future for GSK on this index?
Thomas?
Yeah. I always start when I talk about the medicine, the Access to Medicine Index. This is not the primary goal of GSK. We are trying to do the social responsibility activities with HIV drugs as well as with medicine and vaccines on the GSK side. That's the primary goal, and it is very, very nice and rewarding to see that an independent organization, which is funded by investors, the Gates Foundation, et cetera, independently, has judged over the last eight cycles to put GSK as number one. If you follow these activities closely, you might have noticed that over time, the top three, four companies have become fairly close.
The difference between the first and the second and the third is rather small now, which I could also claim as an, you know, success of GSK because we have pulled the entire field up. I think it's very good that more and more companies invest in that space and want to shine. We welcome the Access to Medicine Foundation and their work and are obviously happy that we have so far covered the number one place. Thank you.
Okay, fantastic. At this point, I think that we're going to move back into the next session. You have approximately 15 minutes to join the next virtual breakout session, which start at 3:15 P.M. British time and 10:15 A.M. Eastern Time. Details are available on the Zoom events landing page or via the email you received. All the presentation and event recordings from each of the breakouts will be available after. Obviously we've made it so you can attend two sessions. Thank you so much for attending our Global Health or Health Impact session right now. I'm going to close this Zoom now. Looking forward to seeing you all at the Q&A at the end. Thank you very much for your time, and we will see you later. Bye-bye.
Okay, we are just congregating here in the breakout session on seasonal respiratory viruses. Hello, everyone. Welcome to this breakout session focused on seasonal respiratory viruses. I'm Jeff McLaughlin from the GSK Investor Relations team. Today I'm joined with Phil Dormitzer, who's the Global Head of Vaccines R&D, and Christi Kelsey, who's the Global Head of Vaccines Commercial. Luke Miels, our Chief Commercial Officer, is also with us today for the Q&A portion. You'll see on slide 2, our usual safe harbor statement, and as a reminder, this session is being recorded. We move to slide 3. Just to give you a purpose of this session is so you have a chance to ask questions.
First, Phil and Christy will share a bit about some of the exciting work that we're doing specifically to help prevent seasonal respiratory viruses. With that, I'll hand over to Phil, and we'll pick up on slide 4.
Thanks, Jeff. GSK has pioneered novel research methods and technologies to help protect people from infectious diseases for the past 70 years, and we have a strong track record of successful commercial execution. What are we referring to when we talk about seasonal respiratory viruses? By seasonal, we mean respiratory viruses that typically circulate around the same time every year. Today, we'll focus on RSV, influenza virus, and SARS-CoV-2, the virus that causes COVID-19. A respiratory syncytial virus, or RSV, has been talked about a lot lately. One reason, because it was a very bad RSV season this past year in 2022, 2023.
Second, for the first time ever, we now have vaccines approved to help prevent this common virus, which can nevertheless be devastating, especially for certain adults who have weakened immune systems or who have comorbidities, as is the case for many older people. Each year in the US, RSV leads to approximately 177,000 hospitalizations and 14,000 deaths among adults 65 and older. Further, adults with underlying conditions are more likely to seek medical services and have higher hospitalization rates than adults without these comorbidities. According to the CDC, more than 90% of adults hospitalized for RSV have underlying medical conditions. Now, influenza is caused by another common respiratory virus, and this one infects nearly 1 billion people annually and can lead to severe complications, including pneumonia, heart failure, and death.
Of course, SARS-Coronavirus-2 has caused over 750 million confirmed cases of COVID-19 worldwide and has caused millions of deaths. One important distinction among these three seasonal viruses is that, unlike influenza virus and SARS-Coronavirus-2, RSV is very stable genetically. It comes in 2 subtypes, A and B, but it does not change over time, with anything like the rapidity of influenza virus or SARS-Coronavirus-2. We do not anticipate that regular strain changes will be needed for the RSV vaccine. I'll now pass on to Christy, who will outline the opportunity.
Thank you much, Phil. We'll go to the next slide, and thank you, Jeff, for the intro. Arexvy, obviously, as Phil mentioned, a lot of discussion about RSV. This is our newly approved RSV vaccine for older adults, and this is approved based on exceptional efficacy. First of all, in our clinical trial, Arexvy demonstrated an impressive 94.6% efficacy in people with at least one comorbidity and 82.6% overall efficacy against lower respiratory tract disease caused by RSV. Now, what's important here, especially when we think about patients with underlying medical conditions, is these are patients that suffer the most. These are the patients that have the highest burden to the healthcare system.
Talking with our customers, because naturally, we've been approved by the FDA for over a month now, our customers do see this as a key differentiator for Arexvy. Our profile, we feel, is very strong, and we look forward to your questions there. We are aiming for market leadership based on the Arexvy profile, and this will be a multibillion sales potential vaccine, which further builds, as you heard from both Emma and Tony at the setup, on our very strong presence in adult vaccination. If we go to the next slide. Last week, at the CDC's ACIP committee meeting, the Advisory Committee on Immunization Practices, we presented the much-anticipated Season Two data, indicating that Arexvy provides protection over two complete RSV seasons. Importantly, we also saw a consistent tolerability profile.
Importantly, it's also of interest that the GSK follow-up period was for 18 months. Because of the efficacy data I mentioned before and the continued efficacy demonstrated over two complete seasons, we now have a recommendation to use Arexvy for the prevention of RSV disease in adults aged 60 and above with Shared Clinical Decision Making. What this means is, in the U.S., over 77 million older adults now have access to this vaccine, and they have access ahead of the upcoming RSV season. If you think about our lifecycle management program, we are just getting started. We have a very robust lifecycle management plan with additional data updates and filing later this year. This will include our flu coad data, which includes adjuvant and high dose.
This again, will supplement the coad data that we already have in our label, the phase III data, we will have later this year for our phase III study in 50 to 59, in older adults, 50 to 59 years of age. We also expect additional regulatory decisions in the back half of the year. For our current recommendations for patients 60 and above, our launch efforts are very well advanced. Stock is in the distribution center, we are ready to go. Phil, I'll pass over to you for our flu program.
Thanks, Christy. Currently available flu vaccines are suboptimal, partly because the viral antigens drift in the circulating strains. They even drift sometimes between the time that a manufacturing campaign for a given season starts and when the vaccines are administered. There's a high risk of mismatched antigens, one of the key reasons why you see such variability in the efficacy of current flu vaccines. mRNA vaccines have the potential to disrupt the flu market, which is estimated to be more than $8 billion by 2028. mRNA can be manufactured quickly and easily, and it can be readily adapted to keep up with the changes in the virus, which makes it an ideal technology for responding to emerging and changing flu strains.
Along with our collaboration partners at CureVac, we announced preliminary positive phase 1 data from monovalent flu mRNA vaccine that showed a strong functional antibody increase at the lowest dose level tested and good tolerability at much higher dose levels. We're now developing, based on this platform, a next-generation multivalent mRNA flu vaccine that can be used to protect against multiple influenza strains. The phase 1, 2 trials are underway, and we're encouraged by what we've seen thus far. With the CureVac platform, we look forward to the multivalent data by the end of 2023 or the beginning of 2024. Next slide, please. We're also pursuing a SARS-CoV-2 mRNA vaccine using the nucleoside modified, sequence-optimized CureVac platform, which we believe has the potential to combine strong immune responses with an acceptable tolerability profile.
The tolerability will become increasingly important for differentiation as we move beyond the pandemic and into the post-pandemic era, where consumers will want something better tolerated than the current COVID-19 vaccines. With this, we're well positioned to introduce mRNA combination vaccines to help protect against these variable seasonal respiratory viruses, and this could lead to more convenient and effective patient vaccination schedules and the potential for higher immunization rates. Next slide, please. In summary, key upcoming events include launching Arexvy and building further clinical evidence to support its profile. Those next steps include additional flu co-administration data, phase 3 data in 50 to 59-year-old adults, including those at high risk, and further regulatory decisions, like the decision we saw recently in Japan.
On mRNA, the focus is on developing an optimal platform for multivalent and combination seasonal respiratory disease vaccines, with ongoing work to support a profile that can achieve needed efficacy with good tolerability. As a reminder, we look forward to the multivalent data by the end of 2023 or the beginning of 2024, and we're committed to developing innovative vaccines that can help protect people from respiratory viruses, building from our long and successful history in both vaccines and respiratory health. As our pipeline emerges, we can continue to make significant and positive contributions to help prevent infectious diseases worldwide. Now, we'll move to the discussion, and I'll hand it back to Jeff to moderate the Q&A.
Great. Thanks, Phil. We'll now move to the Q&A. As a reminder, using Zoom, to ask a question, just raise your hand using the icon in the menu bar, and I will open your line so that you can ask a question. If you've joined Zoom via phone, please press star nine to register a question and then star six to unmute, if needed. Can I just please remind everybody to limit your questions to one per instance that you've been called upon, so all participants who wish to ask a question will have a chance to do so. If there's time, we'll come back around, and people can have another chance to ask a question.
As I mentioned earlier, Luke Miels, our chief commercial officer, has also joined our breakout session here, to address additional questions that may come up. We will now move on to the Q&A portion, and I'll go to Graham Perry. Graham, I'm gonna allow you talking privileges now, and you can just unmute yourself.
Great. Thanks, Jeff, and thanks for the presentation. Just on Arexvy. The recommendation from ACIP was for Shared Clinical Decision Making in a single dose only. I guess, can I just check how that was sort of compared to your original expectations? To get a second dose or continual dose regimen, do you think you have to go back to have another ACIP meeting to recommend a, you know, a repeated schedule? There were certainly some comments at the ACIP meeting from some participants sort of arguing, "Oh, well, you know, if it's single dose, I'd have to sort of give this when they're in their 70s to get best protection." Do you have an uphill battle now in terms of, you know, commercializing this, just given those two factors from the ACIP meeting? Thank you.
Thanks, Graham. Thanks for your question. It's Christy here. I think maybe a couple of clarification points. We were never expecting a recommendation on the frequency of vaccination at this ACIP meeting. In fact, why ACIP was keen to see the second season data is, of course, to answer the question of, "Is your efficacy durable?" We showed very clearly that the efficacy is durable over 2 seasons, and also to answer the question about safety. Do you have a consistent safety and tolerability profile? We wouldn't expect a recommendation on revaccination until we actually submit that through a supplemental BLA, and we would expect them to want multiple seasons of data, probably a minimum 3, 4 seasons of data, before that type of recommendation is made.
Just, and Phil can provide some context on the timeline that, for that. As far as shared clinical decision-making, I mean, for us, we're very happy to have this recommendation. It means that you have over 77 million people that are eligible for this vaccine. As far as the shared clinical decision-making approach, we're very familiar with this from our work with Bexsero. It means we just need to work hard to continue to raise awareness, but because of a lot of the work that has already been done, in fact, 90% of HCPs are telling us that they're ready to recommend, and about 64% of consumers have told us that they're actually ready to request a specific vaccine.
so not a surprise as far as the market opportunity and recognition that we'll need to have additional data to provide clarity on the revaccination recommendation, which we wouldn't have just after 2 seasons of data. Phil, I don't know if you wanna share how we're continuing to look at that question?
Sure. You know, we always anticipated that we would head back to ACIP after we see data from a third RSV season. In addition now, having seen that you really don't need a boost after a single season, and you don't get much of a boost either, we're gonna want to go on to examine the dosing interval. We'll wanna see what a boost looks like after two seasons gap from the first immunization, and probably after three seasons gap as well. Depends a bit on what you see after two seasons gap. We will continue to gather data through at least one more season, and we anticipate going back to ACIP with additional data.
Can I just double-check that was all, that those revaccination timelines were all prospectively designed into the original phase 3 trial design?
The original design was that we would give 3 annual doses versus 1 dose and then just watch them. We are responding to the data we've seen, and saying that it's probably, you know, and this needs to be discussed some, but it probably doesn't make a lot of sense to give another annual dose at this point. We're probably gonna get a lot more useful information if we look at what it looks like to space out those dosing intervals.
Great. Thanks, Graham, for the question there. we'll move along. The next hand raised is from Folashade. so I will open allow you to talk now. If you can unmute yourself and ask your question.
Hello?
Yes, we hear you.
Perfect. I just wanted to ask, you gave timelines for some mRNA flu vaccines that look a little bit longer and perhaps more realistic than others in this space. Could you outline your expectations for regulatory requirements to get this approved?
Sure. you know, you may have seen some of the data that CureVac has released are looking at a monovalent flu vaccine. The purpose of that was to really first establish the platform, a platform where you could get, you know, strong immunogenicity with low doses, but good tolerability with much higher doses. We're now in the clinic testing a variety actually of multivalent formulations. Those data should come out the end of 2023, beginning of 2024. Obviously, we'll select the best formulation and then move on to phase 3 trials.
There should be a pretty, you know, there'll be a number of data points that we get as we start to look at first multivalent and then move on from there to start phase III trials for flu.
Thank you.
Excellent.
Thank you.
Thank you for that question. We'll now move on to Emmanuel Papadakis. Emmanuel, I'm gonna allow you to talk. You can ask your question.
Thank you.
Apologies. There you go, Emmanuel.
Okay. Thank you, sir. Be curious to get your perspec-.
Oh, can we hear?
I think you're back on there, Emmanuel. Apologies.
Yeah, you. I mean, it may be intentional, but you keep muting me. What I was gonna say was curious to get your perspective on the potential for or significance of a combined seasonal respiratory vaccine, i.e., RSV, flu, potentially COVID. Do you think it has any role to play now, given the multi-season data we've seen for the RSV vaccine? If so, which role, potentially, and are you working on one, either in the form of combining your recombinant RSV vaccine with an mRNA-based flu vaccine, or indeed, in the early stage of an mRNA-based RSV vaccine? Thank you.
Phil, why don't you take the, what we're looking at in the clinic, and then I can talk about opportunity?
Sure, that sounds good. you know, we certainly are looking at combining the COVID-19 and the seasonal influenza vaccine, both variable viruses with annual immunization. The finding that the RSV vaccine appears to be is likely to be a more than one season vaccine makes, I think, that combination still possible, but perhaps less appealing. There could be other combinations that at this point would be at the research stage. Christy, should I turn it through back to you for that? Yeah.
Yeah, the, I mean, the only build I would say is, of course, this is quite an active area, Emmanuel, as you can imagine, just looking at the vast clinical development plans in this space. I think we need to see the composition of revaccination. We could start to see a market that has a blend of seasonal, kind of, more rapidly mutating viruses and multi-seasonal for less stable viruses. I think more to come. Certainly we'll learn more.
Yeah, I would just add, look, I think, Emmanuel, the opportunity for a tripler is gone. You know, what was keeping me awake at night before this second season data is an mRNA tripler flu, COVID, RSV. I think the likelihood that we're gonna see that is very low now, just because of the construct of mRNA, and that's why our effort is focused on the doublet, the flu-COVID proposition, rather than the triplet. We see the RSV market as really being dominated by a protein adjuvant.
Okay, thank you.
Thank you, Emmanuel, for the question. We're gonna move along now. The next question is from Zane Abraham. Zane, I'm gonna allow you to talk. If you wanna unmute yourself.
Hi there. Thanks for taking my question. Just back to RSV and looking at the second season data, clearly a robust protection through the second season. At the same time, we didn't see a benefit with the booster. Just curious to know a few initial thoughts on why there wasn't a benefit, even though the immunogenicity data suggested an increase both in antibodies and T cell response. Perhaps tied to that, what is the base case now that you're assuming for revaccination in the GBP 3 billion peak sales target that you've set?
Yeah. You know, it's certainly a known phenomenon that you get a better booster with a longer interval from the initial immunization. As immune response is waning, you tend to get a better response. I think it's an empirical question, how long is that best interval for revaccination? You know, again, we'll try to come up with an empirically based answer to that question. My expectation is it's just a matter of waiting to the optimal interval to deliver a boost.
Excellent. Okay, thank you.
I think there was a question there, as far as our assumption. Yeah, the price range that we've assumed, it assumes a 2-year, every other year vaccination schedule based on the data that we have. Of course, we'll continue to see more data over time.
Thanks, Christy.
Great, thank you.
Yep.
Thanks, Zane, for the question. We will now move on to the next question from Will Hamlin. Will, I'm gonna give you talking privileges here.
Hello. I've just got a follow-up from the earlier question on the regulatory pathway for mRNA, flu, and COVID. Are you relying on trying to show efficacy standalone and get them approved standalone, and then, you know, once both standalones are approved, then you just show, you know, title levels to basically are the same in the combo? Or are you trying to get regulatory approval for the combo? If so, you know, what would the comparator arm be in any trial?
Yeah. I think the pathway is to seek regulatory approval of the standalones and then of the combination. For flu, there's a, you know, well-established accelerated pathway where you can actually get a license based on serology, achieving, you know, accessible HI titer, and then with a demonstration of efficacy to follow. For COVID-19, it appears that Europe is going to accept immunobridging to current vaccines. The U.S. would like some sort of efficacy data, but that could either be from a prospective trial, a human challenge trial, or potentially even a real-world evidence once you license that in Europe, but based on immunobridging. A combination, and we would anticipate that you could then immunobridge the combination of back to the standalones.
Of course, discussions are ongoing about all of these things, but that is the leading pathway that we're considering right now.
Okay, thanks. And if there were competition kind of already there ahead of you, would that make any difference to the approval pathway?
Certainly, being able to immunobridge to an existing licensed vaccine is helpful. You know, I think we really have caught up quite substantially, particularly in the flu area. We are seeing that with the published data from others on initial attempts at a flu vaccine where, you know, some of the responses weren't quite where they might be hoped to be and where there was a fair amount of reactogenicity has really reinforced our strategy of getting the platform right first, and then going in with a number of different formulations to really try to get something that really has both the immunogenicity and the tolerability that we desire.
I do think we're catching up in that regard, and there, it's great to be first out, but there's also some real advantages to being able to bridge to existing vaccines.
Yeah, great. Thanks so much.
Thanks for the question, Will. We only have a couple of minutes left here. Just as a reminder, if you'd like to ask a question, just use the Raise the Hand feature. I do see one more question in the queue. It is from Graham. We'll come back around to you, Graham. Just pause for a moment in case anybody else has a question before we give you a second shot. It looks like Graham has removed his hand. I guess he's withdrawing that question. I think if no other questions, we can wrap things up. Does any, Luke, any final remarks or comments from you before we go into the larger Q&A?
I think just 1 point earlier on the ACIP recommendation. I think, going into it, we certainly were hopeful on a full recommendation, but we were expecting no support for the 60 to 65 zone or low support. It's a bit of a wash. To Christi's point, it's not insurmountable to navigate physician involvement, and I would argue in some ways it helps us, which I can expand upon in the next session. We got a broader population, that 60 to 65 cohort. Net, net, I think we, you know, we left the field happy that day.
Excellent. I do see one new question from Zane. Zane, I'm gonna give you a chance to ask your final question here, in the last minute or so before we move back.
Sorry, just one quick follow-up on the RSV pricing, and appreciate that, it's yet to be finalized. Just in terms of what was presented to ACIP, you presented a base case at $270 versus Pfizer at two hundred and again, appreciate both are yet to be finalized. How might that look in practice in terms of having two vaccines with a similar recommendation, albeit with your comorbidity data at different price points? How should we sort of think about that, or should we think about that as a sort of moving target still?
I think both companies are going to try and get as close as they can to each other. Contracting will start next week. I don't think any company will wanna disclose until the last minute. Yeah, I think the ranges that we've placed in both companies are probably likely to be adjusting based on what they learned from the other data set.
Great, thank you very much.
Excellent.
Thanks.
Back up on time, we really appreciate everybody participating in this breakout session. You have just a moment to flip over to the larger Q&A session. Details to do that are available on the Zoom events landing page or via the email that you have received. Just wanted to thank our panelists and all of your questions from the attendees, and thank you for the interest in GSK. You can please disconnect now and move over to the other session. Thank you.
Now I'm gonna share my screen with the presentation. Share, and I'm gonna go from the beginning. Excellent. Thank you, everyone, for joining us today. Welcome to this breakout session focused on invasive bacterial and fungal infections. I'm Josh Williamson, in the investor relations team, and today I'm joined by Kumaran Vadivelu, Head of Vaccines Development, R&D; Rob Bowers, Head of General Medicines Commercial; and David Redfern, President of Corporate Development, who will be joining us for the Q&A portion of this call. On slide two is our usual safe harbor statement. The purpose of this session is to give you a chance to ask some questions. We will start, but we will start with around a ten-minute introduction from Kumaran and Rob on some of the exciting work we are doing specific to bacterial and fungal infections. Kumaran, over to you.
Thank you, Josh. I'm thrilled to join you this afternoon to share some of the exciting work in vaccines R&D. A global healthcare company committed to finding new ways to prevent and treat disease, one of our focus areas is bacterial and fungal infections. On this slide, you can see some of the common infections that continue to significantly impact patients worldwide. Vaccine-preventable diseases like meningitis and pneumococcal continue to hospitalize and kill people every year. In the U.S., more than 150,000 people are hospitalized from pneumococcal pneumonia every year. Even with antibiotic treatment, 10%-15% of people infected with meningococcal disease die. These statistics underscore the urgent need for improved vaccines to address this pressing medical need. Over to you, Rob.
Thanks, Kumaran. There also remains a significant unmet need for patients affected by common community infections like urinary tract infections and vulvovaginal candidiasis, which I'll refer to as VVC. These diseases are amongst the most common infections that women will experience, but their impact on quality of life for patients is often overlooked, especially given the burden of resistance and recurrence in these patients, combined with the lack of innovation for decades. The lack of new oral options for complicated UTI means that patients with resistant infections have to be treated at hospital with IV antibiotics. Over the next few slides, we'll give you an overview of our key pipeline products in this space, and then we'll open up for Q&A. Please turn to the next slide. Back to you, Kumaran.
Yeah, thanks, Rob. The first program I would like to share with you is our pentavalent ABCWY meningococcal vaccine, a vaccine designed for the broadest meningococcal disease coverage. Our five-in-one MenABCWY vaccine builds on the legacy of Bexsero, our market-leading meningitis B vaccine, and integrates MENVEO, covering ACWY strains. There is an opportunity to improve immunization rates among U.S. adolescents for MenB, which is currently only at around 30% penetration. Recently, we presented preliminary pivotal data on our five-in-one vaccine candidate, which met all primary endpoints, demonstrating statistical non-inferiority compared to Bexsero and MENVEO with an acceptable safety profile. On top of that, our pentavalent is the only investigational vaccine to have shown immunological effectiveness against a panel of 110 diverse MenB strains, which account for more than 95% of those circulating in the U.S.
We are on track for a US regulatory submission in 2024, and our life cycle management efforts feature additional work to pursue global licenses and expansion into infant populations. We expect combination vaccines to drive incremental growth in the overall meningitis market by improving compliance and immunization rates. As illustrated in the table on this slide, the introduction of a pentavalent meningitis vaccine for US adolescents could potentially reduce number of required doses for those aged 16 to 18. Please turn to the next slide. Before the Affinivax acquisition, we had a gap in our vaccines R&D portfolio as we were limited in our assets for pneumococcal disease, a $7 billion market opportunity. Despite the routine recommendations and widespread use of pneumococcal conjugate vaccines, we know there is still a considerable disease burden among older adults and young infants.
Current conjugate vaccine technology limits potential coverage to 20 out of the 100 known serotypes and provides suboptimal protection for some serotypes, such as serotype 3. The most successful next-generation pneumococcal vaccines will provide both, 1, higher serotype coverage and broader immune responses. Referring to the bar chart on the right side of the slide, you can see that introducing a 24-valent vaccine developed using our MAPS technology could boost coverage to above 60% of the disease. An expansion to a 30+ valent formulation could increase coverage to over 90% of the disease. Next slide. This figure represents the differences between MAPS technology on the left panel and conventional conjugate technology on the right panel. MAPS technology uses high-affinity biotin-rhizavidin binding interactions to present immunogenic epitopes of both pneumococcal polysaccharides and pneumococcal protein antigens to induce B-cell and T-cell responses for robust immune protection.
B-cells initiate response to the pneumococcal polysaccharides, and B and T cells respond to the pneumococcal protein antigens. MAPS offers two distinct advantages over traditional pneumococcal conjugate vaccine. First, MAPS facilitates higher valency. This means that expanding coverage beyond 20-30 serotypes is much easier proposition than with chemical conjugation. Second key differentiator is that MAPS complex is more immunogenic and also introduces an additional form of immunity, specifically T-cell-mediated, pneumococcal-specific anti-protein immunity, something that is unique to MAPS. Traditional glycoconjugate vaccines, like PCV, employ a protein carrier, CRM197, that is unrelated to pneumococcal disease and therefore do not stimulate pneumococcal-specific anti-protein immunity. Next slide. This slide presents the results of phase II, involving older adults, demonstrating the clinical proof of concept for the technology, as well as MAPS 24-valent candidate, which forms the foundation for proceeding to phase III.
We are confident that our vaccine candidate, leveraging MAPS technology, holds significant promise to reshape the pneumococcal vaccine landscape due to, 1, its high valency, 2, robust anti-polysaccharide immunity, as shown in phase 2 data presented on this slide, including higher response for most serotypes. I would like to draw your attention to serotype 3, where we observed threefold increase against PCV13. 3, a broader immune response facilitated by inclusion of pneumococcal protein. Collectively, MAPS technology attributes are critical for improved disease coverage and potentially enhancing efficacy against invasive disease, as well as showing greater impact on mucosal diseases like pneumonia and otitis media. We are making progress in advancing our development, with the aim to be the first to market with the 24-valent vaccine.
We expect phase III trials for adults to start in 2024 and are targeting the launch of a pediatric vaccine before the end of this decade. Additionally, we are on track to advance our MAPS 30-valent formulation into the clinic in 2024. At this point, I would like to pass the presentation over to Rob.
Thanks, Kumar. In addition to preventing infections, we must continue researching and developing new treatments for bacterial and fungal infections, including those at the community level. ESBL producing bacteria can negate the effects of commonly used beta-lactam antibiotics. As you can see from the chart on the top left here, rates of ESBL producing bacteria are increasing in complicated UTI in the U.S. The majority of these bacteria are multi-drug resistant to any oral treatment, hence, the reason they are deemed a priority pathogen by both the WHO and the U.S. Centers for Disease Control. This necessitates IV therapy for a condition that would previously have been treated with oral therapy in the community setting.
For VVC, our market research shows HCPs see 30% of their patients as complicated or challenging to treat due to the impact of resistance or recurrence, with no other oral options for patients after fluconazole. On the right-hand side of the slide, you'll see where we've outlined what we see as the key criteria that are essential to developing a successful portfolio and becoming commercial in this space. First, we're focused primarily on infections with large populations and significant unmet needs. By focusing on the portion of these patients with the highest unmet need, for example, patients with resistance or recurrence on existing therapy, which is about a third per group, we have a portfolio with the potential to reach $2 billion in peak year sales. Additionally, we're focused only on novel first-in-class assets that are differentiated and have efficacy against resistant pathogens.
All of our assets address or have the potential to address WHO priority pathogens. This designation is an important signifier of high and increasing unmet need, and is commonly used as a key qualifying criteria for future pull incentive policies that are being developed in the US, Europe, and the UK, designed to incentivize and reward antibiotic innovation. Finally, we know that bringing oral outpatient treatments for common community infections has strong commercial value, which is aligned to outcome-driven impacts, like reducing hospitalizations and reducing pressure on the hospital system. We see a significant opportunity to lead in this space and to build a unique portfolio of first-in-class, best-in-class medicines with synergistic strategies. This large unmet need in a market with decreasing competition, matched with our commercial and R&D capabilities in this space, makes us confident that we will be a key leader in this area.
With new policy initiatives and pull incentives emerging, GSK is well positioned for these significant upsides should they come to fruition. Next slide, please. On this slide, you can see an overview of the anti-infective assets that we've invested in with near-term potential. All of these assets are novel or first-in-class oral options for community or outpatient infections with growing resistance. If we start on the left-hand side with gepotidacintidacintidacintidacin, this is a first-in-class triazaacenaphthylene, or TZAP, antibiotic. Its distinct mechanism of action provides activity and broad coverage against most strains of E. coli, including those resistant to current antibiotics such as fluoroquinolones or, and ESBL producers. In November, we announced that our phase 3 studies were stopped early for efficacy, following a pre-planned interim analysis by an independent data monitoring committee.
Data was presented at ECCMID, demonstrating non-inferiority against the most commonly used first-line treatment, nitrofurantoin, in both trials, and additional superiority in one of the trials. Gepotidacin demonstrated a consistent treatment effect in patients with the highest unmet medical need, who are those with resistance, a history of recurrence, or aged greater than 50 years. Despite black box warnings and FDA guidance to reserve their use in UTIs only for patients with no alternative options, fluoroquinolones are still commonly used as a second-line antibiotic in the US, with close to 25% market share. gepotidacintidacintidacintidacin has the potential to provide a valuable new treatment option that can displace fluoroquinolones, preserving fluoroquinolone use for other serious infections and in line with good antibiotic stewardship practice. gepotidacintidacintidacintidacin only needs to displace one-fifth of current fluoroquinolone use to become a $1 billion medicine in the US.
We're currently preparing the U.S. submission. Given the opportunity we see in this space, in order to build out a world-leading infectious diseases portfolio, we announced an exclusive license agreement with Spero Therapeutics for tebipenem. This is a late-stage antibiotic that may treat complicated urinary tract infections. Tebipenem has a clear U.S. FDA regulatory path to potential approval, with phase III clinical trials starting in 2023, following encouraging U.S. FDA regulatory feedback on the proposed clinical trial. Finally, in March, we added a third asset to our portfolio through an exclusive agreement with SCYNEXIS to commercialize and further develop Brexafemme. This is a novel, approved antifungal medicine with a broad spectrum of activity against existing and emerging resistant strains of fungi, including vulvovaginal candidiasis and with potential in invasive candidiasis.
Brexafemme has a distinct mechanism of action whereby it kills the fungus, as opposed to some antifungals, which inhibit fungal growth. It's the only oral antifungal U.S. FDA-approved treatment for VVC and reduction in the instance of recurrent VVC. GSK plans to relaunch the VVC indication are underway, and we also have a phase 3 program in invasive candidiasis underway. Candida auris is an emerging multidrug-resistant fungus cited as an urgent threat by the U.S. CDC, alongside other serious drug-resistant Candida species. We're developing Brexafemme to address this emerging threat. Next slide, please. We're looking forward to the opportunities we have for our bacterial and fungal infection assets, including meningitis, Streptococcus pneumoniae, and our anti-infectives portfolio.
On meningitis, we are working closely with regulatory agencies to review the complete phase 3 data before U.S. regulatory submission in 2024. On pneumococcal disease, we plan to start our 24-valent vaccine phase 3 program in 2024, and move our 30-plus valent vaccine into the clinic in 2024. Finally, on our anti-infectives portfolio, we're excited about the significant opportunity to lead in this space and to build a unique portfolio of first-in-class, best-in-class medicines with synergistic strategies. With that, we will move to the discussion. Josh, I'll hand it back to you for the Q&A.
That's great. Thank you very much, Rob, and thank you very much, Kumaran. We will now go to Q&A. As a reminder, to ask a question on Zoom, please raise your hand using the icon in the menu bar. I will then open your line so that you can ask your question. If you have joined the Zoom using the telephone numbers provided, please use star nine to register a question and star six to unmute if needed. If you've joined by phone, please state your name and organization. Can I please remind everyone to limit questions to one, to be fair to all participants, please? Thank you very much in advance. I'm now just gonna wait a moment to see if anyone uses the raise hand function in the first instance. Just pause momentarily. Okay, great.
Got a question from Colin White. Colin, I've given you permission to talk. Please come off mute.
Hi, can you hear me?
Yes, loud and clear.
Hi, just a couple of questions from me. It's Colin White from UBS here. I just wanted to know what you thought of the Vaxchora 24-valent data that was presented earlier in the year, and how you think your vaccine will be differentiated? Secondly, if you could help me out with the timelines on the Candida auris with Brexafemme, when might that be able to be used to treat that, and what do you think the size of the opportunity is there? That's all. Thanks.
Thanks, Colin.
Yeah. Thanks for the excellent question. First thing is about our comment on Vaxchora results. First thing to note is Vaxchora candidate was compared against PCV20, which is a less immunogenic vaccine. On top of that, we did not observe clear statistical superiority of Vaxchora compared to the current standard of care. I would like to reinforce the key advantages of MAPS technology that will help to deliver potentially best-in-class vaccine, which are, number 1, ability to make high valency. You have seen that with 24 valent data. 30-plus valent will get into clinic in 2024. There are two more things I want to draw your attention to. First, is strong antibody-mediated immunity against polysaccharide.
I mean, you can see in our phase 2 data, we observed a 3-fold increase in response to serotype 3 compared to PCV13. That clearly surpasses current standard of care and the best the pneumococcal field had seen so far. Second one, that's unique to MAPS technology, we think it's a X factor, is the inclusion of native pneumococcal proteins to induce broad immune response, both T cell and B cell, targeted against the protein, which could go on to have both an effect on serotype 3 as well as non-vaccine types. Collectively, we feel these features would position us to potentially deliver a best-in-class vaccine in the pneumococcal field. Your second question about the pediatric trial?
Yeah, I think it was.
Yeah.
I think it was around the timing, and then it was the Candida auris for Rob afterwards.
Okay. We have just completed phase I trial for the pediatric 24-valent vaccine candidate. The ongoing phase II trial, which started in June 2022, is temporarily paused following an audit finding related to the fill and finish presentation of the vaccine. I want to reassure you, we are very reassured by the phase I data we have seen in this population. It validates the technology's potential in young infants, and we are working diligently to resolve this matter as soon as possible to resume phase II study.
Okay. Thanks, Kumaran. Rob, over to you.
Yeah. Thanks for the question. The key study that we're using for invasive fungal infections is the MARIO study. That's active as we speak. It's an oral step-down study that's live, and we're expecting that to read out in early 2025, and we'll then be sort of following after that. To your point about how big an opportunity is that, at the moment, we see the bigger initial opportunity in the US in the VVC space initially, but the importance of the invasive fungal infection is not to be underestimated. And actually, ex-US, that will be most likely the bigger opportunity.
Thank you.
Great. Thanks, Colin. Just give it another moment to see if anyone else has got a raised hand. In the, in the interim, unless Colin's left his hand up for another question. Don't know if that's the case, Colin. That's fine. No worries. Thank you. In which case, one of the questions that we often get to the investor relations team and during engagements is kind of one for you, Rob, which is: You know, you've got the portfolio. We have the portfolio of three anti-infectives, and we've now kind of attributed this around $2 billion peak year sales potential. You know, people don't always necessarily understand why we're that confident in that level.
Perhaps you could, you know, run us through some of the key reasons to believe and some of the key factors that are driving that kind of that estimate.
Yeah, sure. I think I sort of shared these synergistic strategies. I think all three of these medicines share common factors. The first is, they all address large populations. There's 50 million episodes of UTI in the U.S. every year. There's 3 million complicated urinary tract infections. There's 10 million VVC infections. These are large initial populations to work with. What they also share is there's very, very clear populations with important unmet needs. Generally, across all three, you're looking at resistance populations or recurrent populations and resistant to recurrent to the existing standard of care. Therefore, what we're bringing with these medicines is essentially a unique option where no alternates exist.
For example, in complicated UTI, 3 million cases a year, you know, near enough, 20% have this ESBL infection, which has no alternative oral option. With tebipenem, you've got the ability to introduce a medicine there, which means patients can get out of hospital quicker or prevent their admission in the first place. I think they all share those three factors in common, and if you've got economic tailwinds like you have for tebipenem, it makes real kind of commercial sense, as well as addressing a really important patient unmet need.
No, that's great. Thank you, Rob. Again, just to remind, if you have a question to ask, please use the Raise Hand function, or if you're dialing in on the line, please press star 9 to raise to your question and then star 6 to come off mute. Whilst people maybe consider what they want to ask, maybe, Kumar, I'll go to you just quickly, just to, you know, again, kind of similar question in terms of what are the key reasons to believe that, you know, our pentavalent meningitis candidate is going to be differentiated and grow the market?
Yes, sir. Thanks. We view the MenB component as the distinguishing factor between vaccines. We think the ACWY components are highly similar across various products. We feel confident that Bexsero's proven track record of robust clinical data, real-world effectiveness, will be reflected in customers' preference when it comes to MenBCWY combination vaccine. Another reason to believe that MenBCWY will transform the space is today, the MenB vaccination coverage for 16 to 18-year-olds stands around 30%. With the introduction of combination vaccine, we believe we can increase the coverage closer to what MenCWY vaccine has achieved, which is around 60%. That's what we see as a great opportunity to potentially double the number of people receiving MenB vaccine over time.
That's great. Thanks, Kumar. Again, I'm gonna make a call to see if there's anyone that would like to raise their hand and come off mute and ask a question. If not, we might actually call the session and give everyone 5-minute break before the collective Q&A back in the main kind of plenary session. I'll just pause for a moment there and give people the opportunity. In which case, I think thank you very, very much to everyone for attending and listening to the presentation and to the Q&A. I'd also like to extend a big thank you to our speakers as well, for their great presentations.
You now have about 5 minutes before the group Q&A, and the final Q&A session begins, which starts at 15:45 BST. Details are available on the Zoom events landing page that you use to navigate to this event. Also, just as a reminder, all presentation and event recordings from each breakout session will be available on gsk.com. Again, thank you very much to all the panelists, and thank you very much to all of you listening in to the call. Thank you very much, and have a great rest of the day.
We'll just give it a moment for the attendees to go up. I can see a few people are joining. But in this one, we will have to be prompt. What I'll do is, let's get going. Thank you, everyone, and welcome to this breakout session focused upon chronic viral infections. My name is Mick Reedy from the Investor Relations team, and today I'm joined by Chris Corsico, SVP of Development, Lizzie Champion, VP Vaccines Commercial for Shingrix, James Greenough, SVP Specialty Care Commercial, and Tony Wood, our Chief Scientific Officer. Slide two looks at our usual safe harbor statement, and the purpose of this session is to give you a chance to ask questions around our, around some of the exciting work that we're doing specific to chronic viral infections. At this point, I will hand the presentation over to Chris.
Thank you, Mick, and welcome everyone to this breakout session. Infectious diseases continue to pose a significant global health burden and threat, despite the fact that there have been advances in therapy. Today, we're gonna highlight three important chronic viral infections, where GSK continues to focus its efforts to address unmet medical needs. The first, herpes zoster virus or shingles, which one in three people will develop in their lifetime. The second, hepatitis B, a viral infection in more than 300 million people. Finally, herpes simplex virus, a lifelong incurable infection responsible for genital herpes. It's now my pleasure to turn it over to Lizzie Champion, who will provide an overview of Shingrix and our excitement about this important vaccine. Lizzie?
Great. Thank you, Chris. I'm delighted to be here. Shingrix is a flagship vaccine, and if I start with what the vaccine has delivered, which you can see on the left of the slide here. The first and only shingles vaccine to demonstrate this kind of efficacy, 97% efficacy in pivotal clinical trials, and that efficacy sustained at more than 80% over 10 years and counting. If I talk then to the performance to date, moving to the middle of the slide, 5 years into launch, Shingrix has grown to be a GBP 3 billion product as of last year. Much of the early success we've seen with Shingrix, of course, has been in the US, where we've already reached 30% of the 120 million Americans who are eligible for the vaccine.
That leaves around 85 million Americans still remaining unvaccinated, which shows the headroom we still have in the U.S. If I then talk to the ex-U.S. picture, which is an important part of our growth for Shingrix looking forward, we have accelerated launches fast. We are unconstrained on supply, and because of that, are well on track to be in 35 countries by 2024, and those 35 countries represent around 90% of the global vaccines market by value. This geographic expansion is really starting to deliver significant growth, as you can see on the chart. As of last year, over 1/3 of our Shingrix revenue was delivered ex-U.S., and more than 50% of the growth came from outside of the U.S.
Looking ahead now, we are firmly on track to deliver our commitment to double Shingrix revenue, delivering GBP 4 billion by 2026, and we expect Shingrix to be a multi-billion product through the decade. I wanted to share some thinking on opportunities, lifecycle expansion opportunities we have for Shingrix, and I'm going to touch on three. If I start with population expansion first, and I wanted to share some news that you might have seen already this week related to population expansion. As of yesterday, we announced an expanded indication for Shingrix in Japan for the prevention of shingles in adults aged 18-49, so 18 years and over, adults at increased risk of shingles.
Another area of population expansion we're looking at is younger patients, so specifically healthy people aged younger than 50, and specifically, I'm gonna talk about the cohort of 40-49 year olds. This cohort is big. In the US, it's around 40 million people, and we know that there's an unmet need here. We know more than around 100 cases of shingles per year in that cohort in the US alone. With the duration of protection that Shingrix has demonstrated, we are now able to consider bringing the benefit of shingles vaccination to this younger group. Currently, we're focused on better categorizing the burden of disease and the public health impact in this younger cohort in order to initiate discussions with regulators and public health bodies. Second, booster.
Again, referencing the chart on the left, you can see the phenomenal duration of protection sustained efficacy that Shingrix has demonstrated over 10 years. Of course, what we can also see on the chart is some very limited waning of efficacy to date. Of course, we consider the future need for a booster. What I wanted to say here is that it is reasonable to assume that the need for a booster won't be the same across all patient groups. We've got some early descriptive data from immunocompromised patients, and what we see there is that we do see some breakthroughs earlier than 10 years. That immunocompromised patient group, we estimate to be around 10% of Shingrix vaccinees. If we see a need in a broader at-risk group, so patients with broader comorbidities, that number will be significantly bigger.
What we do is we continue to track efficacy over the longer term. We continue our long-term follow-up studies, which define the 10-year data, and that will inform the potential need for a booster, and specifically in which populations. Lastly, I wanted to touch on some emerging science. There is a very interesting, very contested, growing body of evidence, which suggests shingles vaccination is associated with a reduction in the risk of dementia. This includes a recent observational study, which has gained significant attention. I want to be clear, this study is not yet peer-reviewed, but it has gained, for good reason, significant attention. That study shows a 19% reduction in the risk of dementia following shingles vaccination.
It's emerging science, there are significant unanswered questions in this space, as to what underpins the potential association. Of course, any risk reduction here is incredibly meaningful and therefore a reason for us to be excited and put significant focus. I'll now hand it back to Chris, who'll share more on the exciting science we've seen on chronic hepatitis B, herpes zoster, and herpes simplex virus.
Thank you, Lizzie. If I could get the next slide, please. Chronic hepatitis B infection is a viral infection of the liver that can cause both chronic and acute liver injury and disease. When the immune system is unable to clear the virus from the body, the virus persists in the liver and can be detected in the blood. There are approximately 300 million people living with chronic hepatitis B. Chronic hepatitis B results in nearly 900,000 deaths per year related to liver complications such as liver failure and hepatocellular carcinoma or liver cancer. All patients living with chronic hepatitis B must be regularly monitored because they are at increased risk of developing cirrhosis, liver failure, or liver cancer. That means even for patients who are feeling well, they need to continually be followed by their physicians to assess the underlying nature of the disease.
The desired goal of treatment is functional cure. Functional cure means clearance of both hepatitis B surface antigen and hepatitis B viral DNA from the blood after being off all therapies for 6 months or longer. Therefore, to be a successful treatment, the treatment not only needs to suppress hepatitis B viral DNA, it needs to be able to clear hepatitis B surface antigen and in turn, enable the body's immune system to clear the virus. Current treatments include nucleoside or nucleotide analogs, or NAs, and immune therapy, specifically pegylated interferon or peg interferon. Despite these therapies, very few patients attain functional cure.
In fact, patients on NAs typically have functional cure rates of less than 2%, and even adding peg interferon to the regimen while increasing functional cure rates, comes with systemic side effects that make it difficult for patients to remain on treatment for the full 48 duration. About a third of patients are even unable to complete the full treatment course. It's for these reasons that better treatments are needed given the large unmet medical need. Chronic hepatitis B remains a global public health issue, and diagnosis rates remain low. In the U.S., it's estimated that only about 35% of infections are diagnosed and only 25% in Europe. While the rate is double in Japan, Japanese patients are required to be screened based on healthcare policy.
This year, in an effort to raise awareness and also raise and make diagnosis rates increase, the CDC published guidelines that adults should be tested for hepatitis B. As part of our continued mission to get ahead of disease and develop innovative medicines to treat more than 2.5 billion patients, GSK remains committed to finding a functional cure for hepatitis B to complement our prophylactic hepatitis B vaccine. We are excited to be here today to discuss bepirovirsen or bepi, a new agent that could advance the treatment of chronic hepatitis B, potentially providing functional cure. Bepi is an antisense oligonucleotide designed to inhibit the translation of hepatitis B viral proteins from its messenger RNA. Based on our evolving clinical data, bepi distinguishes itself from other investigational therapies by its unique triple mechanism of action.
It can inhibit production of viral proteins, including hepatitis B surface antigen. It can reduce viral replication as measured by reducing hepatitis B DNA. It stimulates the body's innate immune system to suppress the virus. It is this unique triple mechanism that we believe offers the potential for bepi to change the treatment paradigm in chronic hepatitis B by potentially offering patients functional cure. If I can get the next slide, please. Last November, data from the phase 2 B-Clear trial was published in the New England Journal of Medicine. That data are shown on the left side of the slide.
The study demonstrated that at the end of study period, 9% to 10% of patients, whether on a background of nucleosides at 9% or not on nucleosides at 10%, achieved sustained loss of both surface antigen and hepatitis B DNA following a 300 milligram course of weekly bepi for 24 weeks, and then being followed for an additional 24 weeks off of bepi. For patients with antigen levels of 3,000 and below at study entry, 12% of the patients on NAs and 25% of the patients not receiving NAs met the conditions for functional cure. In patients with the lowest surface antigen levels, those with baselines less than 1,000, bepi resulted in response rates of 16% for patients on NAs and 25% for patients not on NAs.
The B-Clear study helped us identify a patient population most likely to achieve functional cure. Those patients with a baseline surface antigen of less than 3,000. This informed the design of our phase III pivotal B-Well studies, which are actively enrolling patients. The B-Clear data demonstrated that bepi is needed in combination with other therapies if we want to treat patients who have hepatitis B surface antigen baseline levels of greater than 3,000. Specifically, sequential combination therapy to reduce baseline surface antigen levels before bepi treatment or potential sequential immune therapy after bepi to augment bepi's stimulation of the innate immune system need to be tested when baseline surface antigens are greater than 3,000. Later this year, data from B-Together, our sequential combination therapy using bepi followed by interferon, will be available.
This study will inform the design of our future immune therapy combination studies. We remain excited about the promise of bepi to be a cornerstone therapy, both as monotherapy and as sequential combination partner of choice to advance the care of patients with chronic hepatitis B. Next slide, please. Now I'd like to talk about HSV and genital herpes. Another chronic viral infection that impacts patients globally is the herpes simplex virus, HSV, which is responsible for genital herpes. GSK1104 is a novel therapeutic intervention in early development for genital herpes, and it leverages the knowledge and expertise gained from our work with herpes varicella zoster virus, or VZV. Both HSV and VZV are alpha herpes viruses that lead to lifelong latent infection in neuronal ganglia following initial infection. HSV and VZV evolved mechanisms that enable these viruses to evade detection by the body's immune system.
GSK is building on our internal expertise, knowledge, and experience with Shingrix as we commence early development of GSK1104. Around 500 million people around the world are infected with herpes simplex virus. A third of those patients with genital herpes suffer frequent outbreaks. Beyond the physical outbreaks, genital herpes is also associated with significant psychologic morbidity, stigma, low quality of life, and a threefold increase in the risk of acquiring HIV. Genital herpes is incurable. Antiviral therapy is the only treatment option available, and antiviral medicines only have a modest impact on outbreaks and transmission rates. There's been little innovation in this space for over 20 years. Although GSK1104 is still early in its development, we are excited about the potential for this asset.
With that, I'd like to hand it over to James Greenhough to wrap up on our commercial commitments to growth.
Thanks, Chris. We're looking forward to the opportunities we have for our chronic viral infection assets in terms of the future of Shingrix, the opportunity we see with bepi, and the early excitement we have for HSV. On Shingrix, we're well on the way to doubling Shingrix revenue, but by 2026, we'll be in 35 markets by 2024 and are exploring lifecycle management opportunities. On bepi, we believe our potential functional cure for hepatitis B has potential peak year sales of more than GBP 2 billion. We remain excited about the promise of bepi as a potential cornerstone therapy. Finally, while it's too early to make commercial commitments, we're very excited about the potential Chris highlighted for GSK1104 in genital herpes. With that, we'll move to the discussion, and I'll hand back to Mick to moderate the Q&A.
Thank you, James. We'll now go on to Q&A. As a reminder to ask a question in Zoom, please raise your hand using the icon in the menu bar, I will then open your line so that you can ask the question. If you have joined using a telephone, please press star 9 to register a question then star 6 to unmute if required. Please, could you try and limit questions to one or so? The first question comes from James Gordon. James, you should be free to unmute. Thank you.
Hello. Hopefully, I'm muted, and thanks for taking the question. A question about Shingrix and the booster that was referred to during the intro. My question is: When could you have data that would actually generate a recommendation that people should get revaccinated with Shingrix or boosted, beyond the immunocompromised people? Is it going to be enough just to show that the efficacy from the original vaccination has faded out a lot, or would you actually need to show a benefit from revaccinating them? Do you think that you could get a recommendation for that before you start US sales sort of burning through enough patients that US sales would start to go down because you've done such a good job of vaccinating so many people in the US?
What are the timelines that you get the booster versus when Shingrix starts to go down in the original population?
That was a long question, James, but I'll try and do it piece by piece.
Thank you.
Thank you for the question. booster. I'm going to restate some things and then hopefully also answer some of your question parts. Yes, as you said, it's important that you think about the need for booster across different patient cohorts differently. That's what we believe will be the most likely case. You've seen the 10-year overall data, phenomenal efficacy sustained. The key thing that I'm going to say is we need to continue to deliver that long-term follow-up data, with more expected in the next year ahead, which takes us through to 12-year long-term follow-up data. That data is key to inform the potential need for booster and how broad, which I think is what's sitting behind your question, how broad a patient cohort requires that booster and when.
The one thing I want to say to build on the point around immunocompromised patients is. We believe around 10% of our patient pool currently is immunocompromised. We also know that there are other factors that impact, you know, the ability of the immune system to deal with the shingles virus. What we don't know is how broad that will go, and therefore, how broad the need for a booster is. A vast, vast majority of our patients have some form of comorbidity, so actually, it could be immunocompromised patients, it could be much, much broader. The data, the long-term follow-up data, is key to inform that. I'm not going to be able to share any more on timelines just because we need the data to inform.
What I would say is, we have a commitment to discuss with regulators the long-term follow-up data, and that will be our opportunity to learn more about how we the study that we need to get there. Our belief is that certainly for those initial patients, we will be able to build on immune data without the need for efficacy data, if that was the other part of your question.
Thank you.
Sorry, go on, James.
Well, I just say thanks a lot. It sounds like you do think you would need to do a new study, or it would be on the basis of just showing that efficacy has sufficiently fallen for some populations?
That's right. We don't believe that we would need to do an efficacy follow-up. I want to restate that we are yet to engage regulators on this just because we don't have the data yet, the long-term data yet to inform the need for a booster. That's the long-term follow-up data that's coming.
Thank you.
Excellent. Thank you very much. Our next question comes from Steve Scala. Steve, if you unmute your phone, you should be able to speak.
Thank you so much. Regarding this link between Shingrix and dementia, one question with three parts: What is the hypothesis explaining the link? What is GSK doing with this information? Has no similar signal been seen with RSV? Thank you.
Let me start, and then I'm going to pass to either Chris or Tony from, for any development builds. A couple of things to start with. Of course, this is due to the current available options for dementia. Of course, this is incredibly meaningful, and of course, therefore, it's an area of focus for GSK. It is an emerging body of evidence, so I'm not gonna talk about the association because I know there are many, many questions, but I will hand in a second to Tony and Chris to comment on what we know and what we don't know about the potential association. In terms of what GSK are doing in this space, clearly, we are working with experts.
It is well recognized that there are many questions remaining about this potential association. Those need to be unpicked. The fastest way, at least for us to answer some of those questions, is retrospective analysis. I can't share any more than that in terms of timelines, but you can expect to hear more from us. Let me hand to either Chris or Tony just to build on this really interesting science.
Why don't I just take it at a really high level? Because I'm sure, Mick, you want to move to another question, given we've all got to get to the next session. Hi, Steve. Look, couple of things. First of all, on the RSV comment, if the published study that was referred or the yet to be published study, beginning with the parents, I think, started in 1979 for more than 2 decades. I would say, for the course of our work period, of now more than on RSV, we have data for 2 or 3 years. We're not in a position yet to be able to know before any prospective study can be designed.
With regards to your question about the underlying mechanism, that is still a subject of significant conjecture and will be one of the key elements that must be clarified before investing in a prospective study.
Thanks. Steve, does that answer your question?
Yeah. Thank you.
Excellent. Any further questions, please, could you raise your hand? Okay, we did get some email questions because obviously my email address is on the link. Somebody was asking about, you know, probably something for Chris, about what are the characteristics of a functional cure, and how is it defined from a regulatory and from a practical perspective when we're thinking about Beppy?
Thank you, Mick. The whole space has evolved, but as of today, functional cure means that both the surface antigen level and the HBV DNA level are below levels of quantification, and that patients have to be off all therapies for six months or longer for them to be classified as functional cure. The reason this is important is that with suppression of HBs surface antigen, and with suppression of HBV DNA, we know we further reduce the risk of long-term sequelae, particularly liver cancer. That's why functional cure becomes a very important endpoint.
Thanks. Good.
Performance on the six months or longer, it's not there's uncertainty there. It's related to the nature of the last treatment and the half-life associated with it.
Thank you very much. Tony, we're having some slight issues with your sound, actually. I just, but our last question will come from Evan Wang. Evan, hopefully, you should be able to unmute and please feel free to ask.
Hi, this is Evan Wang on for Seamus at Guggenheim. You know, just as we're talking about bepi and, you know, potential combinations there. I know you described bepi as potential, like, a partner of choice or combination of choice. I guess how are you looking both internally and externally on, you know, I guess, appropriate, combination regimens and mechanisms to combine? Thanks.
I think, Chris. Chris, sorry, please.
Sure. Why don't you let Chris take that, given that you defined it in principle on one of his slides?
There are a couple of ways we're thinking about combination therapy, and the first is, are there agents available that can take patients with high baseline HB surface antigen levels and reduce them, then treat with bepi and then follow? The other is, what can we do on the back end of bepi? Because we know bepi stimulates the innate immune system to build on that immunologic component to further either maintain or draw more patients into functional cure. It's combination sequentially on either end, with bepi being a key component of further driving down both surface antigen levels, driving down DNA levels, but also stimulating the innate immune system.
Excellent. I think, unless anybody has one quick final question, I think that's about all. Hopefully, which is in good time, because the final Q&A session will start in 2 minutes' time, 3 minutes' time. Details for the Zoom events should be on your event landing page or in the email you received. Thank you to each of our panelists and for everybody for joining, and thank you for your interest in GSK. Thanks very much.
Hello, everyone. Welcome to this breakout session focused on delivering health impact at scale. I'm Frannie DeFranco from the Investor Relations team, and today I'm joined by Deborah Waterhouse, CEO of ViiV Healthcare and President of Global Health at GSK, and Dr. Thomas Breuer, Chief Global Health Officer. Here is our usual safe harbor statement. The purpose of this session is to provide you with an overview of our work to deliver health impact at scale. Deborah will give a short presentation, and as always, we'll have plenty of time for you to ask questions, at which point she will be joined by Thomas. With that, I'll hand it over to Deborah.
Thanks, Frannie. As a global biopharma company, we know that our ESG strategy supports our sustainable performance and long-term growth. Specifically, we see the S as an area of global leadership for GSK, with our proven expertise in prevention and infectious diseases. This is why we laid out our bold ambition to positively impact the health of more than 2.5 billion people worldwide, including more than 1.3 billion people in lower-income countries that are often disproportionately affected by infectious diseases. While last year we announced an investment of over GBP 1 billion over the next 10 years to accelerate R&D, led out of global health research hubs in Siena and Tres Cantos, dedicated to infectious diseases that disproportionately impact lower-income countries.
Alongside this work, we also develop access and equity strategies across our commercial pipeline for vaccines and medicines that target priority diseases most relevant to global health. As Emma has said, we are focused on getting ahead of disease together by using our science, talent, and technology and partnerships to deliver health impact, reducing the global health burden while also contributing to the sustainability of GSK, something that I'll talk about over the next few slides. One of the most important benefits of being a global company is the ability to reach people at enormous scale, and I will expand on just a few examples of how we do this. Earlier this year, through our immunization partnership, we reached the milestone of 1 billion vaccine doses to Gavi, contributing to the expansion of immunization programs in low-income countries.
The WHO states that after clean water, vaccination is the single most effective public health intervention in the world. By working with partners like Gavi, we can expand sustainable access and strengthen health, healthcare systems. We're also passionate about the impact we can have on neglected tropical diseases, or NTDs, and the disproportionate burden they have on some of the world's poorest communities. We remain committed to the elimination of lymphatic filariasis globally, and our albendazole donation program has supplied more than 11 billion tablets, driving the elimination of LF in more than 18 countries. The way in which we leverage partnerships is also evident in our work in HIV. Today, approximately 38 million people live with HIV, the vast majority in sub-Saharan Africa, where many people live on $1 or $2 a day.
We're proud of our long-standing partnership with the Medicines Patent Pool, and have agreed the most comprehensive set of voluntary licenses of any company for our antiretroviral dolutegravir. As a result of these licenses, around 21 million people, representing just over 80% of people living with HIV across 122 low and middle-income countries, have access to generic formulations of a dolutegravir-based medicine. In parallel to delivering significant impact for underserved people in lower-income countries, our work creates tangible opportunities to create value across GSK. Let me share some examples of how we do well by doing good to highlight this. The platform technologies developed as part of our global health, R&D, have in turn supported the development and commercialization of other assets in our pipeline. Specifically, the AS01 adjuvant, which was the result of our malaria vaccine R&D, is now used in Shingrix and Arexvy.
Through the FDA's priority review scheme, the approval of tafenoquine, our medicine for the radical cure of P. vivax malaria, unlocked a priority review voucher that enables us to bring forward the commercial launch of a V product in the U.S. by 6 months. Our investment in pediatric reformulations of dolutegravir supported the extension of our dolutegravir patent protection by 6 months, and I can announce today that dolutegravir has been granted pediatric exclusivity by the FDA, extending the patent to April 20, 2028 in the U.S. We will follow the same approach for cabotegravir. Back to the point I made earlier about the scale of our impact, supplying large volumes of vaccines through partners like Gavi provides efficiencies in manufacturing, which lowers overall cost of goods.
Over the next few slides, I'm going to walk you through some of the programs we are working on today that we believe will deliver significant health impact. In many resourceful settings, the greatest barrier to treating and preventing HIV remains access to affordable medicines. Within six months of Apretude, cabotegravir long-acting for HIV pre-exposure prophylaxis or PrEP, being launched in the USA, we were proud to announce a new agreement with the Medicines Patent Pool, granting voluntary licenses for this innovative, long-acting prevention medicine. In March this year, sub-licenses were signed with three generic manufacturers who will help enable access in 90 countries. It's also important that we don't leave behind those who are living with HIV. As you know, HIV disproportionately impacts some of the most vulnerable populations, including 1.7 million children, 99.9% of whom reside in low and lower middle-income countries.
In response, we've created a dissolvable formulation for our key medicine, dolutegravir, increasing usability and accessibility for children and their caregivers. We are delighted that around half of children now on treatment are taking a generic version of our dispersible formulation of dolutegravir, looking to the future, we are committed to developing new and innovative, age-appropriate formulations of our medicines for children, including our long-acting injectable products. Another example I want to share is our work on malaria. Malaria is a disease which continues to take the life of a child under the age of five every minute in sub-Saharan Africa. With our partners, we've developed two products for the prevention and treatment of malaria. The world's first vaccine against malaria, Mosquirix, and a single-dose radical cure for P. vivax malaria, tafenoquine, which is due to be rolled out this year.
Mosquirix is pre-qualified by WHO, a prerequisite for UN agencies such as UNICEF to procure a vaccine, and through the Malaria Vaccine Implementation Programme in Ghana, Kenya, and Malawi, nearly 1.4 children have already received at least one dose of this vaccine, and this rollout continues. To secure long-term supply and reach even more children in malaria-endemic areas, a tech transfer is underway with Bharat Biotech in India. The acceleration of this tech transfer will significantly increase production output of the vaccine, with GSK continuing to supply the AS01 adjuvant to Bharat. The tech transfer illustrates our model of sharing the responsibility of bringing innovative medicines and vaccines to patients. Taking this approach ensures GSK can focus on new developments of innovative candidates. Finally, I'd like to talk about tuberculosis.
TB should be preventable and curable, yet it is the second leading infectious disease killer after COVID-19. In TB prevention, we have delivered proof of concept of the M72/AS01E vaccine, which demonstrated significant efficacy in a phase 2b trial. The results were described by the WHO as unprecedented in decades of TB vaccine research and an important scientific breakthrough. M72 AS01 could become the first new vaccine to protect against tuberculosis in more than 100 years, and the first to show significant efficacy in adolescents and adults. The Bill & Melinda Gates Medical Research Institute, Gates MRI, obtained a non-exclusive license from GSK for continued development of this vaccine for low and lower middle-income countries, and now has the primary responsibility for the ongoing development, including the phase 3 efficacy study.
Importantly, this license does not impede GSK's ability to commercialize the vaccine in upper middle income and high income countries, including China, where TB remains a public health concern. Beyond our vaccines, we aim to change the treatment paradigm in TB and tackle the growing issue of antimicrobial resistance. Since current treatment options can have serious negative impact on patients' lives, we are developing, in partnership with several potential first-in-class medicines, for shorter and simpler treatments. There remains a need for multi-drug regimens, which means collaboration is essential to get ahead of TB, we're industry leaders in multiple multi-sector research consortia to advance their development. Before I close, I'd like to emphasize how proud we are to prioritize our commitment to getting ahead of infectious diseases that disproportionately impact low-income countries.
Our work in this space has been recognized by the Access to Medicine Index, which has ranked us as the number 1 since the index's inception in 2008. We are very proud to be leaders in this space, and we know that our employees are proud, too. In fact, in 2022, our annual company-wide survey showed that our long-standing commitment to global health contributes to why colleagues feel proud to be part of the GSK organization, with the vast majority of colleagues believing that GSK is ambitious for patients, and GSK is committed to making its products affordable and available to people around the world. With that, I will wrap up the presentation and pass back to Frannie for Q&A.
Thank you, Deborah. We will now go to Q&A. As a reminder, to ask questions in Zoom, please raise your hand using the icon in the menu bar. I will open your line so that you can ask questions. If you have Zoom, using your telephone, you just need to press star nine to register a question and star six to unmute if needed. Can I please remind everyone to limit their questions to one, to just be fair to all participants? Thank you in advance. Now I'm going to stop sharing my screen, and I see that we do have a question on the line from Jo Walton. Hi, Jo. I have now allowed you to speak, hopefully you can come off mute and ask your question.
Thank you very much. Deborah, could you tell us a little bit about the timing of the TB vaccine and a bit more about how you share that between the Bill and, excuse me, sound like I need it myself. How you coordinate that and the timelines for getting it to both the lower income and the higher income markets. Thank you.
Great. Thanks so much for the question, Jo. I'm going to actually hand to Thomas, who's leading all the development work on that vaccine. Thomas, over to you.
After we delivered the proof of concept, which was published in the New England Journal of Medicine in 2019, we gave the Gates Medical Research Institute, so not the Gates Foundation, but its arm, which develops medicine and vaccines, a non-exclusive license. Over the last few years, we have essentially transferred all the knowledge, trained them, trained them on tech transfer, and they are in the process of preparing for a large Phase III trial. Meanwhile, they're running a trial on HIV positive patients in Africa. The trial, even though the exact date is not set, but the Phase III trial, which is around 26,000 subjects, so a huge trial, multi-country, is set to start at the beginning of 2024.
As I said, the Gates MRI has a non-exclusive license for essentially all Gavi-eligible countries. All the countries where TB is a major global health problem. GSK has remained the rights for high-income countries and countries like China, for example, which also has TB. You know, the phase III trial, when it starts in 2024, will run a few years and will read out, and then we have to see the efficacy. Maybe the other thing I would like to add is, the TB vaccine is an adjuvanted vaccine, so it has antigen component and an adjuvant component.
The adjuvant is obviously coming from GSK and will, in the future, come from GSK. There are contractual agreements in place to provide adjuvant for the phase III trial, but also should the vaccine be licensed, that there will be continuous supply afterwards. Thanks for the question.
Thanks, Jo. Does that help you? Do you have any follow-ups to that? I think you're still allowed to unmute.
Apologies. Just to understand how you combine that with studies. Will it be a global study with the 26,000 across Africa starting in 2024? Will you be doing your part of it as well, starting at the same time, so it'll be, I don't know, 40,000 or however many it may need to be. Does the lower income come first, or do you do the two together?
Gates MRI will do one study. The study is powered to come up with the ultimate answer of the efficacy of that vaccine. This clinical trial will be sufficient to decide whether GSK has interest to launch it in other countries. From that point of view, it will primarily and first go to the countries covered by the non-exclusive license of Gates MRI. If the efficacy and if the need is there to launch it in other high-income countries, that will be decided later.
I understand now.
Yeah. We will all bank on the same clinical trial, which is large enough to come with a definite answer.
Thank you.
Okay. Thank you very much, Jo. I've had a question sort of emailed over to me around how the Medicines Patent Pool works. Do you have any sort of profit that comes via MPP, a licensing fee, for example, and how does data get collected around the reach of these agreements, and who's responsible for that happening?
I can answer that one because it's related to HIV. We issue voluntary licenses through the MPP. The vast majority of the licenses that we issue are royalty-free, so there's no profit for ViiV/GSK as a result of them. We actually came up with a sort of an innovative idea about four years ago with the MPP, because there were some lower middle-income countries that didn't qualify for the MPP royalty free license product, but still needed some support to get access broadly across their countries. It was, you know, countries like Kazakhstan, Belarus, and a few others.
We actually did a different type of a license with a small royalty on it, and that's really helped the uptake across those kind of middle to upper middle-income countries, where access had been a struggle previously. In the main, for most of the licenses, there is no royalty whatsoever, and there's no royalty anywhere in sub-Saharan Africa. Just to answer that question clearly. The second question is about reach. We talk about the fact that globally, 22 million people are actually taking a dolutegravir-based regimen, but 1 million of them are in developed countries, you know, middle-income, high-income countries, and 21 million are actually in these developed countries, lower middle-income countries. That data is provided by the MPP. It's collected and verified by them and passed to us.
It's quite significant and robust data, and that's why we and they both feel very comfortable sharing that information. That's basically how both the licenses, most of which are sort of voluntary licenses without a royalty. A few do have some small royalties work, and then also how we collect the data to know how many people living with HIV are benefiting from our products.
Great. Thank you very much. Jo, I see that you have a follow-up question, so I'm going to come back to you and allow you to speak.
Thank you. Let's hope I can do this without too much coughing. You say that scale is very important, I know that you do a lot of work to help lower and lower-income countries get access to your products, and you do some tech transfer. Is there anything that you're doing in the opposite direction, in the sense of having transferred some technology, actually helping to build the technology there and perhaps using some of the output, you know, using them as a manufacturer for product that you can then use elsewhere? One of the things that you need to do to help lower and middle-income countries is to build that infrastructure, and you can do that by giving them tech transfer, or you can also doing it by buying stuff from them.
Can I just ask if there's any sort of other help that you're doing to help getting those local factories up and self-sustaining, other than just with your tech transferring?
Thomas, I'm going to come to you because obviously your team does a lot of capacity building. I'll just wait and make one comment about manufacturing, just because it's a very relevant topic to the voluntary licenses that we've just awarded. We look very carefully at who we gave the voluntary licenses for cabotegravir to, and one of the reasons why we chose one of the manufacturers, because they were intending to set up, if they, you know, got the license manufacturing site that would produce cabotegravir for PrEP in Africa. If there is an opportunity for us to support African production within Africa, for Africa, that's something that we that we look to do.
There's a lot of other work that we do, Thomas, if you just want to talk about it, around broader healthcare capacity building. We do this within ViiV, but actually the real scale is in the work that we do in the global health team. I'll let Thomas highlight that.
Yeah. So, I understood your question as a two-prong question. In terms of buying material, buying raw material, obviously, that is a worldwide operation. I don't have the details, but we are very agnostic. If certain things can be bought from African countries to use for manufacturing of medicines and vaccines, that will definitely be done. The other question you had is, and this came up post the pandemic, where African countries said, "Look, again, having not a manufacturing site in Africa is a major disadvantage in a pandemic." As far as I know, two companies, the Messenger and our companies have come forward because the setup of a manufacturing site with Messenger and our vaccine is far less expensive and can be modular. These two companies have come already forward.
We have over the last nine months, had several conversations with African manufacturers, whether some of our products, including vaccines, can be produced there, either from a fill finish or total point of view. Nothing has materialized that I can publicly comment on it, but we are certainly aware of that aspect, and if we can contribute, we will contribute in the mid to long term.
Great, thank you. Thank you, Joe, for the question. If anyone else has questions, please just raise your hand. I see a number of very familiar names on the line, so I would love to come to you. In the meantime, I have another question here. GSK is ranked number 1 on the Access to Medicine Index for a number of years. What are your plans to retain this position? What is the future of GSK on this index?
First of all, when I get asked this question, I always make the point that we are not doing good, or we are not in the global health space to win the Access to Medicine Index. We are doing many, many things, which we have just laid out on the ViiV side as well as on the GSK side, and we are obviously very proud that that has resulted in the number 1 spot for 8 consecutive times since 2008. On the GSK side, essentially, there's a global health team of 200 people, which focus on reducing health inequality, focusing on infectious diseases in low and low-middle-income countries.
We have two R&D units exclusively focused on either developing medicines or vaccines, in, for the global health countries, and we will obviously continue with that. We have huge access programs. Deborah mentioned albendazole, all the Gavi vaccines, which we supply, and as other medicines and vaccines become available in the GSK pipeline on the commercial as well as global health side, we will make them available. With these activities, I'm absolutely sure that the independent Access to Medicine Foundation, which is funded by the Gates Foundation, but also investing, investor companies, that we will rank high.
The other point I wanted to make, over the last eight cycles since 2008, we were always at the top number one position, but until a few years ago, there was a big gap between GSK and all the other companies. When you now look at the first three to five companies, they're all fairly close, which means the entire field has been lifted, and many more companies pay now attention to access to medicine, I think, which is overall very, very good, and at least I give some credit to GSK, who was always on the forefront of these activities.
Great. Thank you, Thomas. Had another one that's come in around global health and the connection to the ESG strategy overall. Maybe this is one for Deborah, but maybe just contextualize for some of our investors, how we approach ESG, how it's connected to the business and the type of global health?
Yes, thanks for the question. We've made a commitment that over the next 10 years, we will impact our ambition is to impact the health of 2.5 billion people. 1.2 billion will be through our commercial business, and 1.3 billion will be through the work that we do in the global health space. That is a goal that have underpins a great deal of the way that we think about ESG. There are 6 core areas that we really focus on, and these areas run all the way through the organization. ESG is not something we do as kind of, you know, on the side of the main business.
This is threaded through everything we do because we truly believe this is a very important part, not just of delivering great financial results, but actually ensuring that we have a sustainable business and have a really strong approach to environment, social, and governance. The areas that we focus on are access to healthcare, global health and health security, environment, diversity, equity and inclusion, ethical standards, and product governance. The work that we do in the global health space is around access to healthcare and then global health and health security. That is both in the work that Thomas does in terms of ensuring that our R&D is delivering innovative medicines for countries who are low income and low middle income.
It also is really a part of how we think about our commercial business as well. If you think about ViiV, you know, we're a great example of all of our products being made available commercially across the world. Actually, we also, through the MPP, ensure that access is there for those countries who are less able to afford those medicines. The same applies to our vaccines and many other relevant medicines that's on the market today and that are also coming through our pipeline. It is an integral part of how we show up as a co-company. We're very passionate about this area, and we think it's very important to do well financially and deliver great results, but also to do good in terms of having a real focus on our ESG agenda.
That's really helpful. Maybe I just suggest we come to Thomas to talk about that cross-fertilization between the Global Health and the commercial business. I think it'd be great to have some comments from you, Thomas, on that.
Yeah. Deborah just explained in great detail that the primary reason we do all this is to show social responsibility in making our products available across the world, including low in middle-income countries. However, there are intended and unintended cross-fertilization between what we do in global health and what we do on the commercial side. Just let me give you a few examples: You're all aware of our highly successful Shingrix vaccine and of the very, very recent licensure of the RSV vaccine. Both of these vaccines contain an adjuvant called AS01, the initial trials to show the advantage of combining an antigen with an adjuvant was essentially the malaria vaccine, Mosquirix, where this was first proved from a proof of concept point of view. This technology is now widely used across many of our commercial products.
Another example are economics of scale. When we produce vaccines which are used in high-income countries and for UNICEF, if you have a much higher manufacturing site utilization, your overall cost of goods go down, which obviously serves global health, but it also serves us on the commercial side. Another example are the FDA priority vouchers. When you license with the FDA certain medicines or vaccines, you get this voucher. We got one for the development of tafenoquine, which is a one-dose radical cure for malaria vivax, and this voucher was used to license one of our HIV products six months in advance in the US, which obviously had positive commercial implications.
It may be something which is not relevant right now, but which might become relevant sooner rather than later, is that certain vaccines and medicines we are developing for low-income countries, due to global warming, these diseases might become all of a sudden relevant to other parts of the world. I would not exclude that certain drugs and vaccines we currently develop exclusively for global health have higher relevance at some point in the future.
That's great. Thank you so much. I think that we now have a couple of minutes to join the final Q&A session, which starts any moment now. Details are available on the Zoom events landing page or via the email that you received. Thank you so much to our panelists and to everyone for joining and your interest in GSK. I'm going to stop sharing and close the session now, and hopefully, we'll see you in the close. Thank you all. Bye.
Okay, just give it another 10 to 15 seconds as people join. Okay, in the spirit of getting started, welcome back, everyone. I hope that you enjoyed the breakout sessions and also the virtual setup. I mean, it gave you the opportunity to interact with Tony, Luke, David, and Deborah, and clearly, members of the team. The intention is to start a broad Q&A session, which we'll aim to finish probably by about 4:15, so about 30 minutes from now. If needed, we can always run a little bit longer. Just as a quick reminder, to ask a question in Zoom, please use the Raise Hand function, using the icon in the menu bar below, and then I'll open your line so that you can ask that question.
If you're on the telephones and using Zoom, you'll need to press star nine to register a question and then star six to unmute, sorry. Can I please just ask everyone to at least try and limit questions to one in the first instance, just to be fair to all participants, and we can always come back for a second round. I'm going to take the opportunity to thank you in advance for your adherence to that. With that, I will start the Q&A. By the looks of it, Steve Scala is the first to raise his hand. Steve, I will allow you to talk. Over to you, sir.
Oh, thank you so much. As a leader in both HIV and vaccines, I'm surprised that GSK doesn't have an HIV vaccine in development. At least I don't think you do. I know it's a tough target, but there have been other tough targets that have been figured out. I assume you will say GSK is monitoring developments in the field, but GSK also argues it's better than the competition, so monitoring developments would be looking backward. How should we think about the HIV vaccine possibility and the risk it presents to GSK? Thank you.
Deborah, do you want me to come to you in the first instance, and then we can also lean on Tony as well?
Yeah, sure. Happy to answer that question. The last 40 years, unfortunately, is littered with HIV vaccines that unfortunately was not able to bring the efficacy and safety that would be required for it to have the appropriate levels of health impact. The reason being, as I'm sure you know, Steve, is just because of the way the virus functions, the fact that it mutates so fast, the fact that the body does not mount an immune response once the virus enters the body in the way that it does to other infectious diseases. We do assess the landscape, you're absolutely right. We also keep a very close eye on all the scientific literature and any signal that there is a way forward to discover and develop an HIV vaccine.
At the moment, that scanning continues, but there's nothing on the horizon that would lead you to believe that you would be successful in delivering that vaccine with the right level of safety and efficacy. You'll have seen recently that J&J, you know, saw their latest attempt fail. I think Moderna are heading into many years of exploration. They've had some challenges with their program, too. For us, we are focusing our energy on longer and longer-acting PrEP, so that we are at least able to protect people from acquiring HIV through therapeutic interventions. At the moment, the science does not appear to give us an avenue forward on creating an HIV vaccine. Tony, is there anything that you would wanna add to that?
I know you and Kimberly Smith, our head of R&D, discuss this, on a relatively frequent basis.
No, I think you've got it exactly right. Overall, look, we've got lots of great opportunities in terms of us. We've got components like immunogens and broadly neutralizing antibodies and an HIV vaccine, reducing a T cell response to the toughest challenges that we have in front of us. I think we've got the right balance here at the moment.
Thank you. Thanks, both.
Thanks, Steve. Can we take the next question from Jo Walton, please, at Credit Suisse? You should be able to speak now, Jo.
Apologies. I'm asking a question I asked earlier because I don't think I got as full an answer as I might have done. Were you surprised to find only a limited benefit of a second dose in the second season for RSV? The answer was, it was a surprising finding. Is there any scientific rationale that might suggest that that would limit this so that this wasn't going to be an opportunity to come back every 2 or 3 years? Can you confirm that your forecasting and your price, et cetera, is effectively set on an every 2-year review? The price will be set, and then if it comes up with, say, a third year of benefit, would you be able to raise the price again?
Just to understand, the possibility that this could be a one-off only vaccine.
Thanks, Jo. First question to you, Tony, and then we'll come to Luke for the question around pricing.
Yeah, look, I would say in terms of were we surprised, no, I think it's perfectly reasonable to expect that vaccine efficacy will wane, and you see a spectrum of that from annual to longer term. Obviously, it's difficult to predict until we see the results. In terms of the why that might be, there are a number of theories that we're exploring. That would be conjecture at the moment, Jo, so I'm, I'll keep that to ourselves for the time being. I would say we're not surprised. We see it very much as within the range of possibilities that one might expect for an adjuvanted vaccine.
Jo, just as background, I mean, Tony's team moved heaven and earth to get the second season data, visibility on that one before we went back to ACIP with the price collar. What was presented is very much informed by the fact that we expect this to be, at least a 2-season vaccine. Now, setting prices, of course, is always a balance. Now, our assumption is that in future ACIP meetings, that we see continued support for a, you know, a multi-year vaccine there, and our forecast is based on that. Also, of course, there are some positive dimensions. We had the inclusion of the 60 to 65 that we had not modeled internally. We thought that that may not get through.
Also the fact that you've got an every second year vaccine is attractive, based on our market research, and there's a high propensity to support this on the part of physicians and pharmacists.
Probably the only other thing to add, of course, we're the only group who designed the study to enable us to compare second season vaccine efficacy with second season boost, and we'll continue to run that out into third season as well.
Thanks, Tony. Thanks, Luke. Our next question is going to come from Foshade at Redburn. You've been enabled to talk, so please go ahead.
Thank you. On R&D cycle times, where do you think time has specifically been saved? If any, is it applicable to the rest of development efforts outside of vaccines?
Yes. Thank you for the question. Time has very much been saved on the across the entire spectrum of clinical trial activities that would be associated with not only data collection, but ultimately filing. If you take the vaccines combination out, which of course, is all at the favorable end, we still see improvements. That's not to say, though, and I don't want to give the impression that we think the job is done, but in either development or in research, there's still more work for us to do to continue to drive improvements based on both data and platform technology opportunities for both the development organization and the research organization.
Thanks, Tony. Can we take the next question from Graham Parry, please? Just bear with me, Graham. Over to you, Graham.
Great, thanks. It's a follow-up, actually, from the RSV section as well. I guess Phil was sort of suggesting that maybe to establish a repeat vaccination schedule versus the 1 dose that's been recommended by ACIP, you could, you need data perhaps coming back and revaccinating, you know, every 2 or every 3 years. Can you just remind us, I don't have the trial design in front of me. Can you just remind us, is the trial prospectively designed to measure that, or is it just an annual vaccination, a year 1, 2, 3, versus just no follow-up?
Then to follow up on Joe's question, if you didn't get a boost with revaccination after a year, after the first year, is there any sort of biological reason why you would expect to get a boost after a two-year or a three-year gap? Thank you.
Yeah, Graham, I'm not gonna comment on the design of our studies. We don't typically share designs and comment on it to John's question earlier. In terms of giving you a more nuanced sense of what we might expect to see, you know, for me, we may saw the typical performance of the vaccines against different populations. I might ask you just to provide additional piece of color to that.
I'm not sure it's just me, I couldn't quite hear that, Tony, actually.
Yeah, Tony, we can't hear you. It's very muffled.
Give me a second.
That's better.
That's better.
That's much better.
That's much better.
Better. All right, look, let me just repeat it quickly then, I'm gonna invite Phil to make a comment. I don't think we've disclosed the design of our phase two ongoing study, so I can't comment on that beyond the high-level comment that I made to Joe. With regards to what might occur looking out to phase three, sorry, to a third year of pro-protection, obviously, that's something which fits within the range of possibilities that I mentioned also in my answer to Joe. Phil D, I might just ask you to perhaps add a little bit of color to that.
Sure. You know, it certainly is observed routinely in animals and certainly in humans as well, that allowing longer intervals between a prime and a boost, allowing the immune response to fade, leads to better boosting. I don't think there's any reason to suspect that anything is going on here that is fundamentally different than what has been seen with other vaccines. We haven't seen how RSV vaccine is behaving in humans before, and we're learning now. I would say that what we've seen suggests that a longer interval between prime and boost will probably be optimal, and, you know, that will need to be determined empirically.
Okay. Thank you.
Thanks, Phil. Thanks, Graham. Can we take our next question from Levin at Redburn as well? Levin, you've been unmuted, so over to you, please, sir. Levin, you'll need to unmute on your side.
Sorry, I was on mute.
No worries.
Yeah, thank you for taking our question. One quick one from us. How should we think about the price of bepirovirsen?
Was that the price, sorry, Levin?
Yeah, the price. Yeah, sorry, the price of bepirovirsen.
Perfect. Okay. Luke, do you want to take that one, please?
Yeah. I mean, I think it's ultimately going to be driven by the proportion of patients that achieve a clinically meaningful functional cure at the end of that. It's difficult to speculate at this point. It is an oligonucleotide, so cost of goods will be a component, and whether you need a doublet, triplet, or mono strategy to achieve a response after initial exposure to nucleotides. Time will tell. We obviously have a range internally, but we're not ready to speculate. I just wanted to double back to Jo's question because I forgot to answer that. Can you increase the price? In the U.S., of course, with the IRA, you're somewhat restricted.
If you look at the natural sequence of launching RSV into Europe and other markets, there's a natural tail period of going through reimburse, et cetera, and we should have the third year's data at that point before we enter pricing negotiations with major markets outside of the US.
Thanks, Luke, and thanks for the clarification. Emmanuel, can we come to you to the next question, please? You should.
Thank you, sir.
Perfect. Thank you.
I know HIV didn't really feature today, but since it is an infectious disease event, perhaps you'll forgive me for asking for a quick update from Deborah on where we're at with the subcutaneous iteration of cabotegravir. I'm referring to the, I guess, steppingstone version before we get to the Halozyme formulations a bit later in the decade. I know you talked about potentially a bridging study facilitating approval as soon as later in 2024 or 2025. Perhaps just an update on where we are with that would be very helpful. Thank you.
Thanks, Emmanuel. Just to recap where we are. We're working very hard, first and foremost, on finding different formulations of cabotegravir, both to ensure that we've got an ultra-long acting, i.e., 3 months and 3 months plus over the coming years. A cabotegravir formulation that can be small enough in terms of its size of dose, that it enables a kind of a self-administered product. We're making good progress with our cabotegravir formulation work, and we are encouraged by some of the results we're seeing, although those won't be available for us to share just for a little while. That's that part.
In terms of the parts that'll go with the cabotegravir, the partners that we've got, rilpivirine, the bNAb, and the maturation inhibitor, and then the capsid. Again, they're all progressing on track, and therefore, we should be in a position to share more with you at the investor update that we are planning for the end of September, early October period. Actually, the real kind of news that will undoubtedly be waited for by yourselves would be what we're gonna choose to take into phase III. That we will be sharing, as we've said, in 2024. We're absolutely on track to do that. The thing I'll just remind everybody is that, you know, the HIV treatment market is pretty fixed.
It grows at 1% to 2% a year, and as we progress all of these options forward, we won't take all of them to market, because obviously, we'll make choices as to what we think will be best at meeting the needs of patients and best at generating financial return for, you know, for the GSK. We're on track. We're making progress, particularly with cabotegravir reformulation, which enables the self-administered, but also an HCP-administered subcut and also the ultra-long-acting intramuscular as well. On track, more news to come.
Thanks, Deborah, and thanks, Emmanuel. Can we take the next question from James Gordon, please, at JPMorgan? James, over to you, sir.
Hello, James from JPMorgan. Thanks for taking the question. Maybe a slightly bigger picture question, which would be. It was flagged in the intro that more than half of the sales, I think you said two-thirds of the portfolio, is now infectious disease and HIV. Is that where it stays, or could you become basically an infectious disease and HIV company based on the things you're talking about? How much synergy is there between infectious disease and HIV and oncology?
Thanks, James. Tony, do you want to talk about how you think about the portfolio? Luke, maybe we can come to you in terms of from a commercial standpoint and delivery of sales. Tony?
Yeah. Look, James, we very much see the opportunity that you described in the infectious diseases area. Now that the vaccines organization is a single part of R&D, and Luke and I have the opportunity to assign capital across the entirety of the R&D portfolio. You'll continue to see us maximizing the potential that we see in that portfolio. Of course, I won't repeat them because we've had sessions this afternoon highlighting some of the fantastic opportunities that we see ahead of ourselves there. I think it's also important, though, to recognize that we have opportunity within the respiratory and immunology areas, backing up on where we are with our IL-5 franchise and with Benlysta, and I'm sure they're gonna be the subject of future meet the management events.
Lastly, just quickly, Mick, perhaps, you know, we see oncology as an emerging area and one in which we're paying careful attention to allocation of capital to ensure that the oncology programs have a PTRS proposition that is competitive with the rest of the portfolio that I've described. I might let Luke now answer with regards to the synergy question, and if it was a scientific one, I'll come back to that later, Mick, perhaps.
Yeah. Thanks, James. Thanks, Tony Wood. I think the commercial synergies are less than the biological synergies, but there are pockets when they can become very meaningful. Tony Wood has alluded to the synergies that we get with the respiratory portfolio and the Shingrix population and RSV. We will have, we have synergies across, say, hepatitis B, Brexafemme, and tebipenem, and we're very mindful of that when we're conducting these types of acquisitions. It's. I wouldn't say it's transformational synergy commercially, but it's very helpful when it occurs.
Thanks, Luke. Just as a reminder for everyone, if you do have a question, then please use the raise hand function in Zoom in the menu bar. Alternatively, if you're on the phone, then please use star nine to register a question, and then you can star six to unmute. Our next question comes from Andrew Baum at Citi. Andrew, over to you, please, sir.
Thank you. Slightly tangential question. You obviously have a collaboration with CureVac on the infectious disease side. Given the emergence of really quite promising data on the oncology side for the antigen personalized cancer vaccines, I know that it's a painful topic historically, given MAGE-A3 and cancer vaccines for GSK, but given the immersion data, very different modalities, is this something potentially as interest or the interest solely stems to the infectious disease space? I'm obviously thinking of the BioNTech and then the Moderna vaccine in pancreatic and melanoma, respectively.
Thanks, Andrew. Tony, do you want to take that one?
Yeah. Andrew, hi. I might answer that sort of in the following terms of the way we think about the cancer vaccine area. Look, we've been following the data you refer to closely as well. I think there's encouragement, but still quite a lot of confusion and complexity in those data. I very much see the opportunity in cancer vaccines as being as much about understanding where the cancer and at what stage of treatment a cancer would have the right characteristics for a vaccine to be effective. If the vaccine's most significant impact is going to be really enhancing what we might call an antigen quality problem. So as we're looking at this, we're paying attention to that component, obviously, in combination with, immunotherapy as well.
I see the technology available to then make those cancer vaccines, be it individualized or common tumor antigen approach, that's just one component of it. Obviously, we're taking a look across a broad range of technology landscapes that might allow us to make a decision as with regards to cancer vaccination at an appropriate point in time. As you know, Andrew, you know, we stepped away from cell therapy in cancer because we saw a greater set of opportunities ahead of us with Jim Pearly and the CD226 assets and other assets in the portfolio like momelotinib.
Thanks, Tony. We'll take our next question from Kerry Holford at Barrenjoey, please. Kerry, over to you.
Thank you. Firstly, thank you for this really thorough review of the infectious portfolio. I guess my question is more big picture, thinking about your allocation of R&D spend in this area. Interested to understand if there are specific disease areas or mechanisms across infectious disease where you feel GSK going forward is going to spend more or less on R&D, both in terms of internal and external investment. Specifically on the latter, are there specific areas within the infectious disease portfolio that could benefit from more business development and external input? Thank you.
Thanks, Kerry. Tony, do you want to take that one?
That one's coming to me, and, please keep me honest on answering all of Kerry's questions, because there was quite a lot in there. In terms of the... Let me start with how we look at the sort of platform technology, contributions or investments across vaccines. I very much look at this as we are extremely well-served with regards to the high priority problems that are in front of us. That comes in the form of protein subunit, vaccines, and, adjuvants. Of course, you know, what you see there is an increasing complexity associated with structurally, structure-based approaches to the design of those.
There are massive opportunities for us in synergies with the pharma part of the organization, for which those technologies are very heavily embedded. In addition, of course, our recent acquisition of Affinivax places us in a strong position with regards to polysaccharide vaccines. Obviously, you're very familiar with the, with the reasons for differentiation that we expect in the pneumococcal area. Just to pick up a little bit on Andrew's comment in mRNA, we're very pleased with where we stand right now in terms of our collaboration with CureVac, and we're looking forward to seeing the multivalent flu data that will be available towards the end of this year to see whether or not the promising profile that we see for reactogenicity and immunogenicity with that platform continues to play out.
Having said that, I think it's really important also to recognize that we're yet to see a phase III success for multivalent flu. Therefore, we're also continuing to examine alternative approaches across mRNA for the future. We have our own internal capabilities that I mentioned that we're building, which are based on orthogonal technologies. We'll continue to explore this space of either nanoparticle design, which plays an important role there, as well as further sequence optimization and less bold and structural changes to enable improved selectivity. That begins to get us into, I'll pause it after this point, I promise, Mick, so it doesn't turn into a 20-minute lecture on vaccines technologies.
That allows us to think about the transition from the existing high-priority portfolio into areas like therapeutic herpes simplex virus, where, you know, one might, the initial, I think, extension, based on what we see from Shingrix, is the best first priority approach there. With the underlying science as to why Shingrix works so well, it has a number of potential explanations, and we need to understand those better before we look at what the future technology landscape might look like. Hopefully, that's not too detailed, Kerry, but gives you a sense of how I'm thinking about it.
Yeah, Tony, I'd just add. Mick, can I just add on the BD point?
Of course.
There's a natural balance that Tony and I have when we're looking at the portfolio and looking at the deals, and there's a ratio that we have informally. Of course, we're not going to give any color on that one today, but as we've said in the past, you can look at the deals we've done and put them into two buckets. There are the momelotinib type transactions where we're looking for a disruptive technology. With infectious diseases, there are a number of deals which we find attractive, because it's a relatively low entry price for the revenue that you get. If you look at the amount of capital that's been deployed to achieve the more than GBP 2 billion that we expect from the UTI portfolio, combined with Brexafemme, these deals.
again, are not transformational in nature, but if you could pick them up without too much distraction, they add revenue and they are profitable. They also are addressing a broader need, which is supplanting broad-spectrum antibiotics or antifungals with more narrowly defined, more effective, antibiotics or antifungals.
Thanks, Tony. Thanks, Luke. Comprehensive answer, hopefully, for Kerry. Just mindful of time, we've got currently three individuals with hands raised, so I'll work my way through them. Jo, back to you, please, at Credit Suisse.
Gosh, I think I'll be asking a question on Dominic's behalf then. I'm sorry, I didn't realize that I had my hand raised.
That's fine, Jo. I can go to Dominic if you want. That's not a problem.
Please do. Please do.
All right.
Save my voice.
All right. Thanks, Jo. Leave it with me. Dominic, over to you. Dominic, you should be able to talk now.
Thank you. The question was just on the proposed European healthcare reforms. One of the proposals is to give a voucher awarding an extra year of European patent life for a drug of your choice if you develop an antibiotic for 1 of the WHO priority pathogens, and it appears that you could also sell the voucher. How likely do you think it would be that this could be gepotidacintidacintidacin? Are there any other assets in development that could also receive this voucher?
I guess, Tony, it's kind of a regulatory question, but maybe there's a market access aspect which Luke might want to comment on as well.
I mean, Mick, at this stage, all I would say is, obviously, we have, as we're thinking about broadening the portfolio, and to Luke's point, that is in the context of tuck in the deals that makes sense from a, if you like, a portfolio standpoint. We're obviously considering the WHO priority pathogen list and the consequences that come with that. For me, right now, it's more of a focus on where we see significant unmet medical need. Luke, you might have additional comments to add there.
Yeah. Yeah, the only thing I would say is, in my experience, vouchers work. It's a very effective, efficient, market-driven mechanism to drive innovation in pockets where there may be reluctance to do it. We don't factor it into our current valuations, but it would certainly have an influence, and I think the success of the U.S. program has been outstanding, and the capacity to monetize those is very useful.
Thanks, both. Okay, last question from Graham Parry then, please, at Bank of America. Graham, over to you.
Great. Thanks. Actually, just a sort of follow-up on the original question about revaccinations, and obviously, just can you confirm you don't need a new phase III trial for extended revaccination? That's probably just the simplest way to put it. Then a commercial stroke R&D question on Shingrix. I think you said in the past, you know, talking about revaccination boosters for Shingrix, but you've also talked about that likely only being for immunocompromised patients. If you can just clarify, is that really what we're thinking about here, and is that just sort of single-digit % of the population that you'd be looking at there? Thank you.
Yeah, Graham. Look, perhaps, Mick, do you want me just to take that?
Yeah, yeah. Please, please.
Graham, as you can imagine, there are a range of questions we're asking about RSV and third season. At this stage, I would say we are looking at how to best prioritize answers to those questions within the context of the portfolio.
Luke, do you want to comment on the second part of the question?
Yeah, sure. I think, Graham, right now, it's just speculation. We don't know when there is a material drop in efficacy, but there will be a point at which, logically, you could re-challenge those patients. Whether that's the full population or a cohort, we don't know. We're modeling both. I think the key thing to reflect on as we've made interest around some of the interesting studies emerging with dementia, we're trying to find ways to extend this portfolio beyond the initial primary population, and a booster is an important component of that. We should know. Next year, we're starting to get some more color with the thirteenth year of the initial sequence, and then we should get the trajectory there in terms of how efficacy and the outlook for efficacy is looking.
Super. Thanks, Luke. Just to sort of round this out, I mean, look, this has been a couple of hours, hopefully well spent for all of our participants. I mean, hopefully, you've learned a little bit more about the excitement that we've got for the vaccines business and the infectious disease portfolio more broadly. Clearly, it's one of the broadest, if not the broadest in the industry. It's representing 2/3 of our pipeline. We've given you, obviously, a deep dive into the areas where we are most excited in the context of delivering growth for the future. It falls on me to say thank you to all of our panelists today. It's much appreciated, but more importantly, thank you to all of you that attended today's session.
Naturally, if you have any feedback, or follow-up questions, then don't hesitate to contact us at ourteam@gsk.com. With that, I shall thank you all, and we'll close the call.