Excerpts from AMRN Fireside Chat w/Piper Sandler on 4Dec2020 re European Opportunity:
Yasmeen Rahimi
Thank you, John, maybe the next set of questions are all tailored towards the approval in Europe, which we're very excited. A decision is expected in early 2021. Maybe the first place to start-off would be like based on the market research study of that. How many people in Europe are on statin therapy with trig above 150 milligrams per deciliter and address would be eligible for VASCEPA? And then the second question is, can you tell us how patients there are treated? It's the percentage of patients under care by cardiologists, primary care docs and endocrinologists, the same as here in the United States. If you could just help us visualize the European market more closer would be very helpful.
John Thero
Sure. So cardiovascular disease is pervasive worldwide, and certainly is pervasive in Europe. There's more deaths from cardiovascular disease in Europe than from any other causing factor of death. Rate of death is about 45% of all death, which is higher in Europe than it is in the United States. In terms of statin treated patients in Europe, there's about 44 million people in Europe on statin including about 32 million in the largest five markets of Europe. This compares to in the United States about 38 million statin treated patients. So there's actually slightly more statin treated patients in Europe than there are in the United States. And roughly a quarter of them have elevated triglycerides and other risk factors.
So a very sizable market opportunity. In Europe, if you're on a statin, you’re more likely to be treated by a cardiologist than you might be if you're in the United States on a statin. I'm not saying that some patients in Europe aren’t treated by their general practitioners on a statin. Or in United States, you might not also be treated by a cardiologist. But proportionately more patients in Europe are treated by cardiologists who are on a statin. And that's good for us in the sense it creates efficiencies, that these higher risk patients are likely more readily reached through the cardiology community. And it should require a more pointed, concentrated sales effort as we try to get into these patients.
We’re fortunate that in Europe, that when we launch, should we launch in with a drug that has cardiovascular outcomes data, usually drugs [indiscernible] outcomes data from the start. We'll also be launching with the two leading medical societies in Europe, the European Society of Cardiology and European Atherosclerosis Society already including the people in their medical recommendations, so we're looking forward to a recommendation from the EMA, followed by the EC approval in the early part of the coming year, and then to focus in on one and reimbursements in there.
Yasmeen Rahimi
And then John, so how many cardiologists are there in Europe, just -- or like relative to here in the U.S., I guess, if we know, and then maybe you could also comment on and this is an investor question coming in saying, when do you plan on sharing with us, sort of potential peak sales or giving guidance? Is the anticipation once obviously, you get the approval, you have to label that you're going to provide a little bit more color?
John Thero
We will continue to provide more information as we advance clearly having a label will add some definition here, just like we did in our label approval in Canada, and in the United States. There are certain idiosyncrasies to label that would be good to have nailed down before we provide too much detail there. But in terms of the market opportunity, Europe is enormous, but ultimately, it's country by country. And I think we could think of the countries in Europe as three primary buckets. There's large countries, which is really the EU5, they're mid-sized countries. And then there's smaller countries, in the smaller countries, which are important Amarin will probably never create its own Salesforce there in market companies that already are well established and can be relied on.
The mid-sized countries, there are some of them that can move sometimes very quickly, relative to reimbursement in Nordic countries, the Netherlands. Netherlands was the second highest enroller in the REDUCE-IT study and a lot of doctors there would like to get VASCEPA go there quickly. So each of those need to be addressed individually. And then there's the EU5, the largest, which of course is Germany and Germany also comes with the distinction of allowing drugs to be launched before agreeing to final pricing whereas in the other four, Big 5, you need to have pricing established first.
So, in Germany, we’ll start early in 2021, putting some feet on the ground doing pre-approval introductions, education, focused in on cardiology, try to increase awareness of VASCEPA. Again, leading medical societies are already there. But focusing in on the cardiologist, they wouldn't surprise me if by the end of 2021 would launch in Germany that we had over 100 people on the street in Germany as being the largest market. The other of the Big 5 don't provide that one year of get in the market, via negotiating price and there our teams will be much smaller, likely a country manager, couple of market access people and some medical people, roughly five per country until that reimbursement comes into play and that will on a country by country basis, we'll be doing them, education and the launch. And how many of the cardiologist we will be focusing on and what portion of GPs, we'll be focusing in on will in part be affected by the label, but also by the level of reimbursement and the timing of reimbursement.
So we will be providing more information on that. But hopefully, those comments are somewhat helpful in providing perspective on size and timing.
Yasmeen Rahimi
Thank you, John. And another question, as you pointed out, so pricing discussions are going to vary from country to country. As you guys have been doing your homework and preparing in those discussions, do you think there's a different flexibility here? We know that patients who have COVID, or patients with cardiovascular disease are at highest risk of COVID? And suddenly, maybe the pricing discussions or maybe it is very different climate than we will look for? Do you think that is going to be impacting the decisions on pricing, given the risk factor?
John Thero
We have three different clinical trials going on in the COVID area, depending on what the results of those trials are, potentially those could have some impact. Right now, we don't yet have the label approved. So, on the reimbursement side it is done country by country. We have started engagement with countries, emphasizing that there is no direct competitor to VASCEPA and putting forth the overall clinical profile. But until we actually have the label, we can't get into those more in detail or formalized negotiations. So, it's really too early to predict the pace at which things will go. I think having outcomes data, having endorsement by leading medical societies and having support from various key opinion leaders will all should help. But it's very early in the process at this point.
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