Karim Fizazi: Thank you very much. Good evening everybody. Thank you for staying. It's late. But no worries, just relax. This is going to be a short talk and soon you will have a nice apéro and a good dinner with friends. So that's very nice.

This is about access to treatments. I'm not a specialist. But you know what? Our Silke and Aurelius, who are super smart, knew that I would not be able to ask a single question during the previous panel sessions. So I thought, I should have a talk. Silke gave me that one. This is what happened. So, also it's a broad subject, as you all know and I had two to select a couple of different things. So just a couple of slides that were previously shown by Dr. Cavalli, that I think this is very important to remember.

First regarding anti-cancer drug cells. If you add the US, Europe, and Japan, you get approximately 95% the rest of the world, just 5%. Now when it goes to cancer incidents, more than 60% of cancers actually occur in the rest of the world. So we have a problem, obviously. A big problem. Second slide, radiation therapy. You will see in blue, dark blue or light blue, those countries that have, let's call it, "Quite full access to radiation therapy." All the rest is in trouble to get access to this very, very important treatment against cancer. We're missing about 5,000 radiation therapy machines across the world. So second big, big problem.

So let me go now to drugs and the use of generic. So, this is an example of what happened almost 10 years ago in some clinical disease, such as hypertension treatments and economists we're able to show nicely that if you're using generic drugs, you can really lower the cost for treatment of a clinical disease such as again, hypertension. More than 50,000, if you're using the branded name drug, versus just 8,000 with generics. So it seems to work in other treatments.

What about prostate cancer, in the past? This is docetaxel. So docetaxel and I took the example of France. But you can use the same in other countries adjusting the price. So in France, 10 years ago, the cost was about 1500€ per cycle for docetaxel and it's now just about 20€, but for cycles. So the system worked, basically. The company was granted some time to get money to pay for the development of a drug, to pay for the failures of other drugs, that unfortunately are failing in clinical research and when the society gets their reward and can save money. So it worked very obviously with this example. But what about now? And actually the situation is probably not so nice as it was to be in. This is more in general in oncology, this is a recent review and it's showing that across cancers and treatments, the cost of current generics might not be sufficiently low for the society to make it work, in most healthcare systems.

So this is in general oncology. Now, what about prostate cancer? In the last decade, I think it's fair to say that we had four or five key or new molecules and you know them. Two of them are already or will soon become generics: abiraterone and cabazitaxel. So let's review where we are. Abiraterone: this is a picture I made some months ago regarding the use of the access-to-generic, worldwide for abiraterone vesture, and it's of course, it's an approximate, don't think a vessel [inaudible 00:04:12]. But see, in just one year, generic abiraterone is arriving in many, many different countries, including big countries. And when I'm saying big countries, it means where there lots of people.

So this seems to be very nice. Fine. But let's go into more details. What's really happening with generics, with abiraterone? I, thanks to some friends, some of them are here, I could show you this example. The US. So generics were authorized in last October. So almost a year ago and as I understand it, coupons for non-insured patients can lower the price, of abiraterone from about $9,000 for the branded drug, to about $2,500. So it's much lower. But still, if you're poor and you're not insured, you're in trouble. How can you pay for that? For a chronical drug? Again, this is monthly treatment. And for insured patients, again as I understood it, it didn't really change anything or just minor things.

Second example, Brazil. There are currently about six generics of abiraterone in Brazil. So you can imagine that there should be some competition. But still, the branded drugs cost approximately 3,000 equivalent of dollars, of US dollars and with a generics, it's just half. So half is of course better. But still many, many men in Brazil are super poor. They just can't afford that. No way.

For example, Europe. Well, we need to wait for three years before we know. Because the patent is protected for the next three years. But actually, as already said in the last two days, there might be alternative abiraterone generics and actually it's about the dose. You may use 250 milligrams with food, with probably the same anti-cancer effect. Of course, we don't have phase three evidence for that. But that's sometimes an option and actually, this is honestly what I've been doing for some years, with some patients coming to me for advice from Africa, when they don't have money to pay for so crazy high price.

What about cabazitaxel? So 10 years of exclusivity for cabazitaxel was granted to the company after the approval. So the generics are expected in one or two years from now. So we will see. Of course, it's hard to say at the moment. But it's going to become important. We will see soon, the CARD data at ESMO and this will probably clarify the situation of whether we should use cabazitaxel in the current situation with abiraterone, enzalutamide, all these drugs. So you'll see soon at ESMO. Now, what about the other drugs? Well, we'll need to be patient and you'll see here, and I'm not going to say all of them, you'll see some of the generic that are expected, and actually, for some drugs I could not get the information because I think it's not public. But we need to be patient.

Now there are other ways to save money and one way is obviously to use surgical castration, instead of medical castration. We knew that for more than 20 years to be honest. But I'm just showing you two recent papers, still confirming again that we're saving money for doing so. This is the first, to the left-hand side, a paper from Toronto. A very recent paper, demonstrating clearly to the left-hand side, is less money, to the right-hand side, it's more money. It's almost like in politics and you'll see that with surgical castration you are indeed saving our money.

Now, the second study from San Francisco. Quite big, 10,000 men. Clearly showing that the use of surgical castration instead of medical castration is directly linked to your social-economic status. Makes sense. So this was short and I haven't heard the bell. This was my goal for tonight. But again, even if those were just a couple of slides, believe me, it was not easy to do. Not for me. But for all of them. So I want really to thank all these people for supplying me all this data. Thank you very much.