Management team. The presentation will then be followed by a Q and A session. Please note that we have time until 9 am for the media conference. At this point, it is my pleasure to hand over to Severin Schwan, CEO of the Roche Group. Over to you, Severin.
Thank you, Nicolas, and good morning, ladies and gentlemen. Welcome to our virtual media conference on the first quarter results. If we can go to the first slide, please. Group sales grew at In the Pharmaceutical division, sales decreased by 9%. This development was actually [SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] Bektte, let me outline the main factor for this development and put it into context.
Which grew 20% in the Q1. On the other hand, the 1st quarter was challenging for the Pharmaceuticals division, due to base effects as the Q1 last year of biosimilars. Again, this was expected as you know for our established cancer medicines in particular in the United States. Now shifting to Diagnostics, sales grew by 55%. And on the one hand, here we saw a continued high demand for our COVID-nineteen tests.
But at the same time and That's really encouraging. Our routine business, which was significantly impacted last year already in the first quarter. Diagnostics was ahead in the curve, recovered and manager. So overall, if we shift to the next and biosimilars on the pharmaceutical business. And we expect managers and patients are resuming their doctor visits.
So if we look at the outlook on the next slide, you can see that we Before I hand over to Bill, let me just point out 2 highlights of our response to the COVID-nineteen pandemic. Next slide, please. So, on the diagnostic side, as you know, we have recently launched The rapid antigen nasal test for COVID-nineteen as a self testing option in Switzerland and also other countries in Europe. The added value of the antigen self test is primarily that it quickly and reliable, identifies highly infectious individuals, so including this potential super spreaders. And obviously with the home test, the threshold for testing oneself at home is to go for a test, especially if they don't suffer from symptoms.
On the pharma side, we have together with our partner Genarvon recently published very strong Phase 3 data on the antibody combination treatment. These results are really impressive with a reduction of hospitalization or death by 70%. The treatment is now benefiting patients in an increasing number of countries including the U. S, Germany, Italy, France and now also very soon in Switzerland. So thank you for your attention.
And with this, I'd like to hand over to Bill. Bill, over to you.
Thanks very much, Severin. So actually, we can go right into the next slide. So as Severin mentioned, Pharmaceutical division declined by about 9% in Q1, And this was largely due to the effect of biosimilars and the COVID pandemic. In the case of the pandemic, that primarily affected the uptake of our new products, Which we've been relying on to offset the impact of biosimilars. And so that's how the impact was felt.
You can see in the U. S. Largely driven by biosimilars and we see improving conditions ahead. If you go to the next slide, You can see the impact by product. And what you see is there's about 10 products at the top that are driving growth, While the biosimilar impact is portrayed at the the 3 rows on the bottom, and I would point out that Avastin biosimilar impact was mostly felt in or the impact in Europe was mostly felt on Avastin because the exclusivity from Avastron was lost in the middle of 2020 in Europe.
Now if you look ahead, in the quarters to come, we actually think that the biosimilar impact has sort of peaked because the amount of sales of Herceptin, Avastin, Imaptera has now come down substantially from where it was before biosimilars. And so there's not as much to ground to lose there. And so we expect a lower impact of biosimilars in subsequent quarters. And we expect to have continued strong growth from the growth products in the quarters ahead. And so the outlook is improving for pharma as we move forward into the rest of 2021.
Next slide, please. So this is a pretty significant milestone because the chart on the left shows the sales as a percent of the total of our new products And those new product offerings launched since 2012, now represent 50% of our total sales, Which is pretty remarkable, considering we were at 19% just 3 years ago. And you can see on the right, The list of products, there's 19 products that we've launched in that period. We've now filed for more or sorry, we're filing for more in 2021. 2 of those, the antibody drug cocktail for COVID, which is Casera and IMDEV and then the port delivery system for Lucentis.
We've completed the filing of those in the U. S. And have begun submitting around the world. And so we look to continued strong growth from new products in the quarters ahead. Next slide.
So I wanted to highlight 2 of these advances in the pipeline. First, faricimab, which is our bispecific antibody. It targets actually 2 molecules that we think are important for eye diseases like macular degeneration and diabetic macular edema. And so, you're familiar with Lucentis, which is our product, our groundbreaking product that targets the VEGF pathway. So farristimab targets VEGF, but another pathway called ANG2.
And we believe that's key to achieving A more thorough reduction in the swelling that causes macular degeneration and macular edema. And what we've shown now in 4 large Phase 3 studies is really compelling results. And essentially, If you think about today's landscape, patients with these diseases, they require between 6, 9, even 12 injections a year in order to maintain their vision. And what we showed with faricimab is that about 50% of patients were able to go, to only 3 injections per year, another 25% could go with about 4 injections a year. And so this is a substantial improvement You can imagine for people that require injection in their eye, and so we we, will be submitting these programs, these filings for approval around the world, yet in 2021.
Also, TECENTRIQ, which is our cancer immunotherapy, that's been available now in multiple indications for about 4 years. We had a really big first in Q1. We announced that TECENTRIQ was the 1st cancer immunotherapy to show a benefit in people who have early lung cancer. So these are patients Whose lung cancer was detected early enough that they could have the cancer surgically removed. And typically today, after that surgical removal, those patients are given chemotherapy.
So we ran a study where half the patients were given chemotherapy and the other half were given chemotherapy plus Tecentriq And what we found was a very meaningful impact on the rate of disease free survival. So essentially, these are patients whose disease does not return. And what we're hoping for in this setting is a cure that for hopefully for most of these patients their disease will never return. And so we're really pleased that TECENTRIQ showed this result. We look forward to presenting these results at ASCO and then submitting filings to regulatory authorities around the world.
Next slide, please. So finally, Severin mentioned a bit about the neutralizing antibody cocktail that we've announced results on. I just mentioned in addition to that, we've continued to deliver results on Actemra. We've done a number of randomized Phase 3 studies. You can see at the top, there's been a mix of results on those.
But if you look at them, we provided the sample size on those. The largest study to read out so far was the RECOVERY study in the UK that had over 4,000 patients and It showed a significant benefit for Actemra treated patients who were also treated with dexamethasone, which is one of the only other therapies that's been shown to have an impact on mortality. The patients that were treated with Actemra had a significant benefit on both reduction in the need for mechanical ventilation, but also an impact on mortality. And so based on these results and the totality of evidence, We've received emergency use authorizations for Actemra in in some countries, and we've continued to supply Actemra to to many countries around the world for use in treating COVID patients. And then I would just highlight at the bottom, you can see TAEO-five twenty seven.
That's a small molecule. That's something that I think the public health authorities around the world have been very much looking forward to and saying the need for basically a pill that you can give people that are infected or people who've been exposed to prevent infection. And so we have an ongoing Phase 2 program in that and we look forward to starting a Phase 3 any week now. So we're actively working with sites to get that going. So more to come on that.
But anyway, we're very proud of the progress we've made in fighting COVID And we look forward to continuing to help the world with that. And so speaking of that, a lot of the help we've done is on the testing front. And I'll turn things over now
management. I'm happy to present the Q1 Diagnostics division performance. With sales of about CHF4.3 billion, we We had 55% growth at constant exchange rate and this growth was driven on the one hand by the COVID-nineteen testing, but also our team testing business, particularly in China, but still the 18% growth even taking that into account is just stellar performance by the routine business. And this is highlighted specifically also in the area of the core lab management. This is again mainly due to the strong growth of the routine non COVID testing.
And this is compared to a higher base last year because we were the 1st company to launch a solution already in January on an EPIC qPCR portfolio and the first company to launch a test that was proofed in the US on a high high throughput platform point of care growing at 281%. This is driven by rapid antigen test sales, diabetes growing at 13% and pathology 9% which was driven mostly by advanced staining. Now if we look at the next slide, we can see that the regional sales growth management. It's coming from all regions and it's coming from all businesses. Latin America, 71% EMEA and Asia Pacific, both at 62% North America 34%.
And as mentioned, we did see already a negative effect in our routine business last year, but that was specifically mostly in China and therefore we did see a strong recovery in China based on this this effect going to next slide, please. Now, since the start of the pandemic, we've developed really in record time people working really night and day, not taking any holidays. 18 solutions to help fight this pandemic. Management. These solutions include both molecular and immunology solutions, both in a laboratory setting and the point of care setting.
Management. This also includes digital solutions and I'll get back to that one as well. Now this test portfolio has become a significant factor in managers. Let me just highlight a couple. First, something that Severin already mentioned, We launched the SARS CoV-two rapid nasal antigen tests, which can allow healthcare professionals to easily collect samples from the tip of the nose, which provides much more convenient for patients.
But we've also launched a version of this test as a nasal self test and this will provide or provides the option for patients to self collect the sample. And this test has been approved for self testing in several countries, managers including countries such as Germany, Denmark, Netherlands, Switzerland, Belgium, Czech Republic, Portugal, Greece, Austria, etcetera. The clinic performance is excellent and was independently validated by the University of Heidelberg in Charite Berlin. Moreover, in a meta analysis that was published of 20 rapid antigen tests across 74 independent studies With more than 30,000 samples, patient samples, the SARS CoV-two test from Roche achieved the highest overall sensitivity of all test studies. Let me highlight another example on this slide, which is the COBASARS CoV-two variant test.
This test helps to understand the prevalence management of different new variants that are emerging. It can qualitatively detect and differentiate SARS CoV-two mutations in variants such as the South African, UK and Brazilian variants. On the next slide. I would like to comment on some of our most recent activities to access external innovation. On 15th March, Roche signed a definitive merger agreement with GenMark to access this novel technology to test for a broad range of pathogens.
In fact, dozens of pathogens just with one patient sample in only 90 minutes. This is called Syntromic panel testing and this will complement our current Roche molecular diagnostics portfolio and with our global reach will be able to take this product, which is predominantly sold in the US today also into other markets. Now infectious diseases are a leading cause of death globally and early detection of the cause of an infection has been shown to improve patient outcomes making sure that we don't have antibiotic resistance, but also length of stay in hospitals. On the slide, you can also see that we'll be launching 800 later in the year, which is also exciting to see how much innovation we've brought to the market in just 1 quarter, management of 2 another great milestones and highlights of Q1. We recently launched the Copas Pure and Copas Pro integrate Solutions for the high throughput segment.
So we completely have a new product portfolio on the system side for our biggest business and really extending our leadership position in this area. Now these solutions are key because We have the opportunity in hospitals and hospital networks to have similar solutions with similar test results, similar tests across the different parts of the hospital network. So the tests are absolutely comparable. And we are the only company that has solutions from the low to the high throughput end. Now let's have first look at Cobas Pure.
With this, we bring efficiency and automation as well as simplicity to the low to mid volume labs. It runs about 8 70 as the Merck area tests per hour. And We have all of our 2 30 tests, more than 2 30 tests on this platform. And this is by far industry leading, having the broadest amount of menu. On the Cobos Pro side, we've announced that we launched this platform on the 23rd March and this is really an ideal solution for high throughput labs.
So overall, I'm extremely excited. Not only what our teams have done to really support fighting this pandemic, but really to bring more innovation to the market also in other areas. Because I mean, if you look at other disease areas. They're also devastating and we need to help people also fight other diseases also beyond
I'd like to remind you that you may use the raise your hand functionality that can be found when clicking on the reactions icon in Zoom to let us know you have a question. If you cannot see this functionality under the reactions icon, You may be using an older version of Zoom in which you will find the raise your hand functionality under the participants icon. You may also ask questions via the chat function in Zoom if you prefer. Please also note that The conference is being recorded and will be made available as a playback on rosh.com within a couple of hours. So we have a couple of questions.
The first question comes from Hannah from the Financial Times. Over to you. Unmute yourself and ask a question.
Thank you very much for taking my question. I just wanted to ask about the antibody cocktail for COVID. There have been problems in the U. S. About making it accessible and making sure physicians were actually offering it to the right patients.
I wondered if that was still a problem in the U. S. And also how you were tackling those kind of issues in Europe?
Yeah, great question. It's actually one of a number of examples In the pandemic times of need of the healthcare system to adapt. In this case, I think probably the biggest challenge has been that The sweet spot, the patients who could have the best benefit are probably those patients who are sick, But not sick enough to go in the hospital. And so, part of the challenge has been that they're requiring an IV infusion. And typically the IV infusions are given either in hospital outpatient departments or private practice, oncology clinics, rheumatoid arthritis clinics.
Manager. And of course, you can't just take someone who's infected with coronavirus and put them in one of those settings. So it's required a bit of an adjustment for hospitals to set up kind of a dedicated room that has the limited equipment that's required to provide an infusion, but that's an area where it's okay to have people that are infected with coronavirus. And so I think some progress has been made in that. Also in the US, there was a long delay between the initial trial results and inclusion of the antibody cocktails in the treatment guidelines.
Those have now been included in the treatment guidelines. And I think outside the US we've been working with the authorities in each country to make sure not only that they have the data required to give approval, but also that they're prepared in terms of actually administering the medicines to patients. And I think you know, I guess I would say we're hopeful that there will be a lot of the medicine made available to patients in the weeks ahead, Especially as some countries are having another wave of coronavirus and even just yesterday we received additional word from countries that are approving it. So management. Anyway, we have a positive outlook, but I think that the IV does remain somewhat of an obstacle
Okay. Thank you, Bill. So the next question is from Michael Griesdorf, I think from the market. Over to you, Michael.
Yes. Hello. This is Michael Christoph from the market. I have three questions, if I may. The first Can you give just the impact on the growth rate of COVID on pharma sales in percentage points in constant currency?
The second question is, I understand correct, is the growth rate in diagnostic without COVID is at 18%, I understand it right, In constant currency and the third question is the self test, your sales now in Switzerland. Can you give a range What do you expect then of sales in this year of this self test?
Management. Okay. So these questions go first to Bill and then to Thomas.
Yes. Thanks, Mikhail. I think The question about the impact in percentage points of COVID on pharma sales is very difficult to answer, not only because It's hard to know how much the effect is on each product. For example, we know that on a number of our new products That fewer patients were seen by physicians last year, fewer new patients, fewer patients with chronic diseases that, let's say, We're not having an ideal outcome from their current therapies, but they didn't go to the doctor, or they didn't go to the doctor in Q1 because of The wave of coronavirus infections. And so that resulted in lower sales, but it's very hard to precisely estimate how much lower.
Also, we know that there was some sort of special sales that happened in Q1 of 2020 when the pandemic was just starting. Some patients were ordering extra boxes of their medicine because they were worried that they wouldn't have it, wouldn't have access as the pandemic worsened. So I'm afraid it would be very difficult to give a precise estimate on that.
Manager. So, to the 2 questions on diagnostics. So, your first one, it's correct that diagnostics Without our COVID portfolio, it was growing at 18% in Q1. Regarding self testing, what I can say is that we do see now somewhat of an acceleration starting in q2 versus Q1 in the self test area. Looking at the full year, you know, I'm hesitant to give a concrete number simply because We need to see how the vaccine rollouts go, you know, and also how the emergence of new variants go.
I mean, we'd see that with emergence of new variants, we see that the protection through vaccines is somewhat impacted and we'll have to see what new variants to come management. And specifically, school children are not yet being vaccinated. So it's really a number of factors which depend on how this will look like. Now when we talked about it at full year, what I said is that we basically put all of our You know, targets in terms of COVID testing into the first half year, not knowing exactly how the second half of the year will look like. I do believe that testing will reach more into Q3 for the year.
But beyond that, I cannot really predict simply because This pandemic is rather unpredictable. And but I also wouldn't declare victory yet on this virus. So we need to keep watching this.
Management.
Thank you very much for taking my question. The first question is for Mr. Schwann. And it's So I guess I'd preface it by calling you the question about management challenges in a crisis. Obviously, just as the pandemic is hitting the drugs business, keeping people away from the doctors.
You are having to spend a great deal of your energy also fixing problems at Credit Suisse where you're the Vice Chairman And you're going to have to onboard a new Chairman. How are you balancing these duties? And how long can you do it? Can you just talk about your thinking behind this? How you balance your time between
I mean, you will understand that at a Roche call, I wouldn't comment on Credit Suisse managers. But certainly on a higher level, there is no doubt that COVID-nineteen puts an additional strain on all of us as we have to manage I think we can be very proud of our contribution in the fight to COVID-nineteen, management both on the diagnostic side and on the pharma side as you have seen in my slides and as you have seen management. From the comments which have made have been made so far. As far as Credit Suisse is concerned, You know that the results will present it soon for the Q1. The AGM is upcoming and I would refer to those occasions for any specific questions around Credit Suisse.
If I could ask a follow-up question for the Diagnostics Chief. Given you expect the you've seen an acceleration in self tests, what advice would you have for people who are using the self test in a manner They're self testing. They get the free tests at the pharmacy, for instance, and then they test themselves in an effort to make themselves safer to go visit relatives. Are the self tests, are they adequate for that? And how would you advise people to use them if you really need a higher viral load to detect disease.
Thanks.
So these tests are excellent to really screen managers and make sure that we detect people who potentially could infect other people. So it's really detecting people that are infectious. And let me just give you a good example in the story of something that has happened actually to the person who is heading our COVID task force in the diagnostics division. Right. So what he had is he had a situation over Easter manage to spend Easter together.
And what they all did is before they actually physically met in the house. They all got tested by the rush test. And what actually happened is that his daughter and the friend were both positive with the test. This was then later confirmed by PCR and it was confirmed that it was the B117 the UK variant. Now if you hadn't done that, He would have been infected and I can say him and the rest of his family were not infected.
These are the perfect use cases. And I think we have a lot of those examples where if people would not have done those things, we would not stop the infections. And so testing is key, absolutely key to stop this. Even if it's not always 100%, if it's 90%, you're still catching 9 out of 10.
Yes, let me perhaps add also here a comment because there's a lot of discussion how useful are self tests, managers, how should you use them, etcetera. I mean, there's no doubt that PCI is the gold standard and the most sensitive test. Management. But with self tests of high quality such as the Roche test, what you do catch and where you have a very high sensitivities if The patient has a lot of virus, right? That is when a test is very sensitive.
If a patient has only a very low level of virus, And you might still catch it with PCR, but not with a self test. So it is about the level of virus, which determines That's a decisive point from a medical point of view because those people who have a high virus load are the ones who are most likely to infect other people. Those are the super spreaders. Now some of them, most of them actually would have symptoms, but some of them actually do not have symptoms, so especially younger people. And that's where the value of the self test comes in.
You catch the people with the high risk virus load, which are typically also the people who are the most infectious ones. So that's where the value comes from. But of course, what is really, really important Is that you use a self test which has a high sensitivity. And let me put it mildly, the variability of the quality Hi. And Thomas referred to these independent studies, which have recently been published.
And I encourage you to have a look at those.
Manager. And also maybe let me add one more thing because actually there are some studies from Oxford University and also from Charite that look at the infectiousness of patients and to what viral loads, you know, they're infectious. So this is exactly highlighting this point. So this is really detecting infectious people that is critical here.
Okay. Thank you, Thomas and Severin. The next question comes from Naomi Kresge from Bloomberg News. Over to you, Naomi.
Hi, good morning. I have two questions, if I might. The first is, you said that your drugs unit is turning the manager. And I wonder if this means that we should expect the sales decline to actually reverse in the second quarter and what assumptions are driving this? What impact should we expect from continued lockdowns in Europe and other large markets?
Manager. I'm also wondering on a different note, how you're thinking about a return to the office as the vaccination drive picks up, particularly in the U. S. Thanks.
Yes. So, Naomi, on the The question about the pharmaceutical outlook. It's really driven by 2 principal parts. One is the biosimilar impact in Q1 was $1,600,000,000 the reduction in sales on Avastin, Rituxan and Herceptin. And we think that that's probably the high watermark in terms of impact in a quarter because essentially the erosion of all three products simultaneously in the U.
S. Only just began in Q1 of 2020. And so there was not much impact in Q1 of 2020, whereas then there was 12 whole months of impact accrued. So the comparison from Q1 2020 to Q1 2021 is where we saw the sort of the biggest impact. In subsequent quarters, we see that loss of sales to biosimilars narrowing, getting smaller in each quarter.
And then we also see a strong resumption of growth for most of the new products management. And that's strengthening over time as the healthcare system returns to normal. We know, for example, in cancer screening, There's been major drop offs in cancer screening and breast cancer, colorectal cancer, in lung cancer over the previous 12 months during the pandemic. Again, as these things start to return to normal, there'll be higher levels of office visits in oncology, in chronic diseases, and we think that will Continue to sort of reinforce the growth of the new products and the combination of those two things We'll have either lower loss or a return to growth on a monthly basis.
Thank you, Bill. On the second question, in terms of working from home or returning to the office, I think that really two factors. On the one hand, of course, is the development of the pandemic in a specific country and related regulations then. So if you look to Asian countries, for example, Again, from the sides. Then on the other spectrum of it, if you look to Europe, Switzerland, for example, People should not go to the office beyond Roche.
So that is obviously one factor. As manager. As the U. S. Is concerned, I mean, clearly the situation is improving.
And I would hope that people can now Increasingly return to the office even though this is not yet the policy, but I hope that soon we will get to this stage. Now the second factor, which is very critical in our industry is what function are you talking about, because there are certain functions Where people just have to come to site. Last but not least, for production and supply chain. I mean, we have to Keep the supply of medicines including COVID medicines and diagnostic tests up and running. And therefore throughout delivery up and running.
And for that very reason, we, our industry in general and certainly Roche, With a very strict to have all other people at home to decrease the infection risk for those people whom they really need on-site. So that's a special fact manager in our industry that some people have to come. And as a consequence, we are particularly careful not to have Anybody else to come to the office to reduce the risk of infection. I hope this gives you
Okay. Thank you. The next question is from Henriette Remberger from RVP. And, Hector, please. Can you hear me?
We can hear you well.
Excellent, wonderful. So three questions, if I may. One is on the biosimilar impact. Just to clarify, so you said when presenting for your results that you expect the impact This year to be around 4,700,000,000. Does that still hold?
I mean, considering 1,600,000,000 in the Q1, that's quite a lot. If you, you know, would just add up, it would be much more than 4,700,000,000, so it needs to come down quite a bit During the next few quarters. Secondly, on this topic, China, what about biosimilar impact there? Do you have any By similar impact in China. And thirdly, on the diagnostics business, How is the situation with supply and demand?
I remember from the full year results that there were some issues about, Not meeting all demand that's there. Thank you.
Thanks, Henrietta. So regarding the full year guidance, So I believe actually the number we referred to was $4,600,000,000 for the full year as a best estimate. I don't want to lend any sort of false precision to that number, but that's still Essentially what we're predicting for the full year, because as I mentioned, Q1 is particularly impacted. So for example, if you look at Q4 of 2020, we had a large impact in Q4 of 2020. When we get to Q4 of 2021, We'll be comparing our results versus that earlier year quarter that had a large impact already, Whereas Q1 of 2020, there was not so much impact.
So I hope that makes sense. If you Look at the graph I showed, for example, the Avastin impact in Europe in Q1 was very large. Well, by Q4 of last year, Avastin impact had already largely happened. So when we get to Q4 of 2021, there won't be so much of an impact. Hope that makes sense.
And then regarding China biosimilar impact, it's a bit of a complex picture because in China, There are some biosimilars, but there's also a lot of patients who are just now getting access because of our inclusion in the In the National Drug Reimbursement List several years ago, the penetration of these therapies is still Reaching the kind of distant parts of China. And so we have a dynamic in place where we're selling more Avastin, MabThera, Perceptin in China and there's also some biosimilar competition. So the net effect In recent quarters, in the last few quarters has been generally either stable sales or slight growth on our end, but that in the presence of some biosimilars.
Yes. So let me answer those questions. First on the antibody tests, both in the lab and any point of care, There is enough supply, but demand is starting to increase, specifically on the lab antibody tests. On the antigen tests both on lab and the point of care there is enough supply there as well. And on PCR tests let me Let me answer it in 2 ways.
1 is giving you a market view and then giving you a rush view. Management. Specifically, if you look in the US, you see a significant drop in PCR testing. But we have not seen a drop in PCR testing. So the market has seen a drop.
We have not seen a drop. And this is exactly happening. What we had predicted that would happen is that People are just tired of using these research platforms and they're trying to consolidate on automated platforms. Platforms like our platform where you just put the tests tubes on and you can walk home and the next morning you come can have good night's sleep the next morning come back and it's done right. You don't have to have people working throughout the night manually to do these test results.
So that's the one component that we see that why people are more trying to consolidate on our platforms and why we have I would say on a market perspective, probably the demand is being met I would put it from that perspective.
Okay. Thank you. The next question is from Dominik Felkis, Ed. Over to you.
Yes. Hello. Thank you. Well, I'm sitting Actually here in just on a personal note in isolation and thank you for your test. Many can confirm, you know, this is rapid.
Manager. I'm not tested positive myself, but someone in the family. And one can really say that management and confirm, you know, the results in 2 cases. But of course, What I also experienced here is that you feel pretty alone here as a patient, you know, because The policy really is still, if you call here in Switzerland, if he is your doctor, please stay away. If manager.
You want to be seen by a doctor, please go to the emergency unit. And then it's really up to the patient to help himself or herself. Obviously, there are some old medicines there out which can be Tried, you know, some with various results, it's difficult, you know, to get an overview. To put a long story short, I mean, we I still think we desperately need such a field, as you mentioned, and I'm a bit disappointed or wondering why you cannot accelerate this, you know, why it This bill cannot be if it's apparently so, so efficient being brought maybe faster to the market, if you could management vaccines but still some pharmaceutical companies even higher which is also not in vaccines has now also provided support to these vaccine providers in production. Manager.
Why are you not doing this as Roche or is this something maybe you might envisage in the future? Thank you.
Perhaps I could just quickly comment. First of all, thank you very much for your personal endorsement How we can actually make a contribution in the fight to COVID with innovation, right? That's really That goes much beyond Switzerland. We see this around the world that unfortunately due to the pandemic, many severely ill patients, hesitating or sometimes even not able to visit the doctors to go to the hospital. We see that that diagnostic screening in certain areas like cancer is not at the levels where it was before.
We see that patients are showing up at the later stage with the disease. So the sad reality is that we will have many people manager who will potentially even die from other severe diseases because they are not diagnosed in time or not manager. If they suspect that something is not all right, that they still managers. So it might be that 1 or the other doctor indeed is hesitant, but at the end of the day, if you are a patient and to get your doctor visit. And I think it's very, very important.
Otherwise, we might You know, reduce perhaps one or the other risk related to COVID, but we have a lot of suffering and people potentially dying from other diseases. So I think that's really very important. Now your last point in terms of our efforts [SPEAKER JEAN FRANCOIS VAN BOXMEER:] On the medicine side, yes, I wish we could launch a pill tomorrow. That's just the very nature of drug development, that it takes some time beyond the recovery of the molecule to then also validate the molecule in sufficiently large patient cohorts. The Phase 2 studies are going on.
And what we do is actually we already plan for Phase 3 at risk. So, we are preparing the Phase III, the confirmatory trials, which you need for registration and approval. We do everything to bring such potential medicines to the market as soon as possible, number 1. And number 2, I should also say The collaboration with the authorities, you know, both for testing and medicines is excellent. I mean, what we have seen over the last year, I would never have thought that is possible.
If you think of rolling filing for example where we share data kind of online with regulatory authorities. So that when the study is completed both the regulatory authorities And the companies at the same information level that has helped enormously to accelerate the approval management. Of new medical options and I mean, in a way it's a miracle that we got the first vaccines already management. With the authorities, I really have to say that on the day it feels like it takes forever. But if you put it into perspective.
It's incredible how fast those medicines and vaccines actually made their way to patients in spite of all the hurdles we still have to remove a particular amount on the supply side. Now why is Roche not in vaccines? It's a different business. And we would be very open to help if we had capacity managers. We could bring in, but, you know, we are, we are just not having those Specific capabilities which are needed now in the vaccine space.
But I should say the collaboration in other areas It's really fantastic. And the antibody cocktail is a wonderful example of that. I mean, the underlying reason why the gentleman and Roche Came together is because we have capacities and a lot of know how in antibody production. And Here we joined forces and that's the very reason why we are able to provide already now those medicines lead. I should also say that.
And wherever we can and wherever we would have capabilities of 3 resources, obviously, we would make them available for vaccine producers as well. It's just not the specific capabilities we have in house we could managers provide for those companies at this stage.
Thank you. Yeah. Mr. Felkest, you have a follow-up question or
Yes, just a quick point because there might have been a misunderstanding a bit. What I was referring to is also what I see as a problem is, you know, with COVID patients, you know, suffering acute symptoms that they are not allowed, you know, to see their doctor and are left managers to their to themselves. You know, I think it's not only because doctors simply don't want to receive them. And I see this a bit of a problem, you know.
Yes. No, it's absolutely fair. And there is a need for the healthcare system to adapt. Actually, Bill referred to the issues around infusion shares for antibody cocktails. I mean, it's a similar problem that if you have a COVID infected person coming to a health institution.
You cannot just enter the normal room where other patients are being treated because managers, you know, the infection risk there. So you have to have a separate patient flow for COVID infection infected patients. That adds Complexity and that's actually what we have seen with the adoption of the antibody cocktails. There's no doubt, everybody agrees that this is a Fantastic medicine which can save lives. I mean, hospitalization and death rates down by 70%.
But there's the logistic challenge That you have to bring the patients to the infusion chair basically. And as they are infected with COVID, manager. You need a special setup in the institutions. And then of course, if it's a small, say, doctor's office, That gets even more complicated. You might not have a second waiting room.
It can be as simple as that, right? And that's the reason why then those patients Have to be referred to bigger institutions. I should say, systems are increasingly adapting to
Still have questions from 3 people. We are very close to 9. We can go a little bit beyond, But I'd like so I really would like to give everyone the opportunity and please keep the answers short. So we will be starting with Etta Lavell.
Over to you.
Good morning. Can you hear me?
Yes.
Thank you. Two brief questions, Severin, just following on from your point about the speed of the regulatory process. Can we anticipate this continuing post pandemic. And a second question, Bill, sadly, the Huntington's Phase 3 trial was stopped fairly recently. Can Can you just talk a little bit about the prospects for Tom Ineson at this stage?
And also, are you working on in your gene therapy in Spark? Are you working on other Possible Huntington medicines or is there any research in the area? Thank you.
Certainly, on the question of regulatory approvals, I would certainly hope and believe that we can benefit from the learnings during this pandemic, in particular The regulators are other players in the healthcare system. They would have said it's impossible. Now for many reasons, right? Now we know that it's possible. And I see no reason why patients should wait for other life saving I have no doubt that it will have an impact on how we work together in the future.
I mean, companies and regulators and I really do hope that we keep this momentum in particular for highly innovative and high value medicines. Bill for hunting.
Thanks for the question. Obviously, it's a very sad situation when we have to stop a pivotal program in a disease like Huntington's where there's such a high unmet need and such a terrible impact on these patients and their families. We were acting on the recommendation of the independent data monitoring committee that You know, didn't see based on their view of the data, didn't see a likelihood that there would be a beneficial effect. We agree with that view and we've stopped dosing. We are following up with these patients to try to have a really thorough assessment of, what happened in terms of the effect of therapy, both at because we had 2 different dosing arms.
I probably wouldn't want to speculate on it. Yeah, I don't think, it's obviously not a good sign for future development of Tom and Arsen. And it's a major setback for the field, but we will do everything we can to learn from the work that's been done. And if there's a way forward, we would certainly pursue it. And we do have efforts not only on termenersen, but in our neurology groups in gRED and pRED looking at what are ways to target this disease.
You asked about gene therapy Because there's a mutant protein that's present and you have to kind of well, we believe you have to Knock that that mutant protein down. That's not so easy to do with gene therapy. I mean, we certainly considering that but gene therapy is sort of better at Adding something than it is at taking something away. And so I'm not sure that gene therapy will be the approach, but I know we will, we're going to continue to work hard to see if we can find some hope for Huntington's patients.
Okay, thank you. So the next question goes to Steen Stovall. Over to you, Steen.
Hi, thank you, Niko. Okay, Bill, could I just ask you looking forward to what's Roche's plans in the area of targeted Cancer vaccines, theory being a combining targeted cancer vaccines with drugs, that could be synergistic. Do you have approaches there that you can tell us a little bit about and flag it as going forward. And, one quick question to Severin. Okay.
You've got the FTC, you've got the UK and Europe, apparently making large, noises about how, they're gonna, managers. Come down hard on potential antitrust issues. Is that something that is going to be taken on board by yourselves going forward? Is it more or less just
Sure. So, on targeted cancer vaccines, We've felt for some years that this is a promising approach. And we did A partnership agreement that we've been involved in now, I think for 4 years with a company that probably most of you hadn't heard of called BioNTech. And we have a cancer vaccine program with BioNTech that's ongoing. And that is in combination with other cancer immunotherapy.
So we think it's a promising approach, but we're still working to demonstrate proof of concept on that. So, you know, we won't know for a bit of time. We also have other programs that are similarly looking to have, you know, sort of targeted immune approaches That are targeted on an individual patient basis. And we think it's a promising field for cancer. So let's see.
Thanks.
Right. On the antitrust developments, I mean, Clearly, we have seen increased attention in this field. I should say it very much originated in the tech I remind you when we did the Spark acquisition, remember this acquisition It was delayed because of the FTC going into a more detailed analysis, right. And eventually, the authorities cleared that transaction, not only in the U. S, but around the world.
But what you can see from that, it impacted us, right? I mean, in a very real sense. I mean, I was spending many calls and many meetings to better understand the situation and managers. Also educate the authorities to a certain degree, because you cannot always extrapolate from 1 industry to another industry and every And again, it's very much coming from the tech industry, but it has, if you like, spilled over That remains to be seen, right? Because if you look at Spark, eventually The transaction was concluded on the basis of what we have expected and the current regulations.
There's Other investigations ongoing and we will have to wait for the outcome of those investigations. And we'll see, you know, and of course, We watch that very closely, so does the whole industry. And that will also have an impact on depending on what the outcome is manager on how we look at potential acquisitions in the future.
Thank you.
Okay. Thank you. So the last question we can take management comes from John Malor. Over to you, John.
Two super quick questions. Bill, does that mean that the Spark program for Huntington's has been stopped because you said it's not a gene therapy is not a real good option. And then the second question, Christophe Franz in March 9th in an interview said weeks until we get the data on the COVID pill. We're going into May or towards May. Can you give an updated guidance on when that Phase 2 data should arrive?
Thanks.
Yeah. So First off, no, I'm not commenting on anything on the Spark gene therapy program. They have research and early development stage programs as are ongoing. I simply mean that there are different types of genetic disorders. Some of them, you have a case where you're missing a protein and it's a relatively easier thing to add a protein When you're missing a protein with gene therapy, then if you have a genetic defect that is causing a toxic protein to form, In which case you have to knock that down.
That's a harder task for gene therapy. It doesn't mean it's not possible. It's just manager. A trickier thing to do. And so, yeah, but There are lots of things that we're doing these days that we didn't think we could do a few years ago.
And so we remain hopeful that we will find a solution. But I think the Tom and Ericsson setback is definitely a challenge.
And otherwise, I wish you a great day. Thank you.
Bye bye.