Amarin Corporation (NASDAQ:AMRN) Citi’s 14th Annual Biotech Conference September 4, 2019 2:15 PM ET
Company Participants
John Thero – President and Chief Executive Officer
Conference Call Participants
Joel Beatty – Citigroup
Joel Beatty
Joining us as you know, I'm Joel Beatty, one of Citi's Biotech Analyst and I'm pleased to have with me John Thero, CEO of Amarin.
So let's get started with, talking about Europe for Amarin given that the ESC cardiology conference just wrapped up over the last few days, I mean, I think, and one thing that came out of it is new guidelines in Europe that recommend the use of Vascepa in patients with triglycerides 135 and up. Can you tell us a little bit about the development of that work for Amarin in Vascepa.
John Thero
Sure and before I get started here, I will throughout my comments be making forward-looking statements and there are risks associated with all forward-looking statements and I suggest investors review our SEC filings and risk factors before investing.
So Joel, a great point on the guidelines, it's been really terrific here since we announced results of the REDUCE-IT study at AHA last November about how physicians have migrated from initially looking to understand the results and now, how do they, incorporate those results into clinical practice?
European Society of Cardiology, is trying to ensure that they are at the forefront of cardiovascular medicine, not just for Europe but globally. And they saw that the incorporation of icosapent ethyl which is Vascepa in their guidelines make sense for treatment of patients. And what they were looking for and recommended in their guidelines is that Vascepa be considered for treatment of patients who despite statin treatment had elevated triglycerides.
We think that as key opinion leaders and medical societies continue to look at how Vascepa might help, patient care that this is going to be helpful to Amarin to patient care overall in particular, to those patients who might benefit. And we look forward to – this sort of builds on the fact that the American Diabetes Association had updated their guidelines earlier this year and American Heart Association had provided a somewhat rare but important advisory update as well.
So KOLs see these results as being positive and we as a company look forward to FDA's review of these results and approval, which we're anticipating before the end of this year, so we can better educate the rest of the world on those results.
Joel Beatty
Great. And how about the – could you tell us about the regulatory strategy in Europe and do these guidelines impact that at all?
John Thero
Our aim and so right now, Vascepa is available and approved in the United States, Lebanon and the United Arab Emirates. Cardiovascular disease is a global phenomenon. Our aim is to submit to the European authorities at sometime in the fourth quarter of this year.
I think that these guidelines are reflecting, KOL views on the importance of Vascepa in treating patients, certainly can't hurt in terms of those regulatory approvals. Also when we get to the reimbursement side in Europe, the support of this as being the – we are the only product in this class in Europe, the earlier generation therapy which was Lovaza over here, Omacor over there has failed a couple of outcome studies last year and EMA removed those, that product from its recommendation for treating cardiovascular patients.
So having these kinds of endorsements behind Vascepa where other products have failed, I think should, should be helpful. Yes.
Joel Beatty
Great. So shifting things back to the U.S., the NDA is already under review at FDA. What indication is Amarin seeking for Vascepa?
John Thero
Today patients for cardiovascular disease are managed in lots of different ways. Some of it's for cardio, some of it's for cholesterol management, but just, statins and ezetimibe and [indiscernible] and potentially some future therapies, hypertension, diabetes, et cetera. But of course there's still a huge risk that remains, which is why cardiovascular disease is the number one cause of death and the most expensive area of healthcare treatment.
We will be looking for a label that's consistent with what we studied in the REDUCE-IT study, which was patients who despite management with all the current standard-of-care therapy will continue to be at high-risk. So, those patients were patients with, multiple risk factors in particular they had elevated triglycerides and what we studied in the REDUCE-IT study where patients with triglyceride levels of 135 mgs per deciliter or higher.
And while triglycerides is a good identifier of risk, we did not design the REDUCE-IT study to validate that triglyceride lowering alone, lowers that risk. But rather what we did is we designed the study to validate that Vascepa when used to study that at-risk patient population in the multi-factorial clinical effects of Vascepa lowered that risk. And that's the indication that we want to be going for the indication we studied in that REDUCE-IT study.
Joel Beatty
Got it. And maybe another way of asking about the potential labeling for Vascepa in the U.S. what specific aspects of the label are most important for supporting the growth of sales?
John Thero
So, I think most important is that it'd be a cardiovascular risk reduction indication today, or approved for, is an important but niche indication for treatment of patients with triglyceride levels greater than 500 mgs per deciliter, which is a population of patients at risk for pancreatitis in the is U.S. about two million to four million patients with that level of risk in the cardiovascular risk reduction, indication if we look at patients, for example with triglyceride levels of 135 mgs per deciliter or greater. And there's data out there suggesting that cardiovascular risk begins to increase as triglycerides unit levels lower than 100 mgs per deciliter.
But if we just look at the population of patients with triglycerides from 135 and above, that's about 90 million people in the United States. If we look at statin treated patients with elevated triglycerides 135 and above, that's about 15 million patients in the United States. So these are big numbers and with a cost effective therapy like Vascepa, we see this as being the first opportunity to treat these patients with a proven therapy.
Joel Beatty
Got it. And then as we’ve seen some – from some of the guidelines, it seems like the focus is on using Vascepa, in patients, maybe above a certain triglyceride cut off but also with higher risk patients. Any talk about these large numbers, I'd say like 90 million in the U.S. with triglycerides 135 and up, are there different ways to cut that, maybe focusing on higher risk patients that, give us a sense of what the market opportunity could be.
John Thero
Yes, I mean, a good point. I mean, if you think about, statins for example, when they were originally introduced, the initial focus was on, patients with LDL levels in north of 200 and then it came down to 180 and 150 and then 100, and then it really, now it's, the lower, lower the better.
I envision that with Vascepa, as we get the label approval and physicians begin to become more knowledgeable of it and use it, they will start with their highest risk patients. This will be statin treated patients, as statins are proven, they've been out in the marketplace for 25 years and, we're not trying to replace statin therapy. Rather we're trying to deal with the multi-factorial risk that exists beyond cholesterol management.
So they'll probably start with diabetic patients, they’ll probably start with patients with an established cardiovascular disease and then probably over time migrate to things like pre-diabetic patients or the patients with other cardiovascular risks. Again, all of these are large populations or subgroups of that number.
And all these really don't have any proven therapy really. They do not have any proven therapy. So Vascepa offers an opportunity to provide a great help to these millions or tens of millions patients.
Joel Beatty
Okay. It seems to me that Vascepa is in a relatively unique situation and that there's already a few prominent guidelines out there talking about it’s use, at the same time while the label hasn't even been granted yet, it's still under review by FDA. The question is how likely is it or how much weight could FDA be giving to these guidelines and then they consider the review.
John Thero
So, FDA has a advisory panel, that they tend to be scheduled for November 14, of this year. As a first ever drug for this large indication, it doesn't surprise us that the FDA is going to have an advisory committee meeting. And anytime you're going through an advisory committee meeting for a first kind of drug, you'd expect that, that review will be, fairly comprehensive. The extent to which the FDA would be looking at, opinions from key opinion leaders and medical societies and patient advocacy groups, relative to its decision making, really is up to the FDA.
I think it is remarkable that, these leading groups recognizes this large need for treating these at risk patients where there isn't any proven therapy today. And I'm certainly hopeful that FDA will take note of, those positions, and move rapidly, to position Vascepa to become available for broad care of these at-risk patients.
Joel Beatty
Okay. And you mentioned the ad comm meeting coming up in a couple of months or so, how is Amarin preparing for the ad comm and what do you anticipate could be the primary focus of the ad comm meeting?
John Thero
So when we filed our sNDA, in March and as a reminder Vascepa, has been in the marketplace now for seven years for a niche indication. So, manufacturing and those pieces of the label review are already, quite well established. When we submitted the sNDA, we assume that there would be an ad comm. We assumed that the ad comm would be, cover a broad range of topics. We've had various, mock ad comms and preparation.
We had originally assumed that, the ad comm would likely occur somewhere in the sort of by now actually by probably in the August timeframe. And we were doing mock ad comms back in the June, July timeframe. The ad comm is now in November, and that will give us additional time to be ready.
We're grateful for the many, healthcare professionals that have, proactively reached out to us to offer their help and assistance and guidance in our preparation for that ad comm. We'll be working with a esteemed group of clinicians and looking forward to putting forward a robust presentation. I'm looking forward to it. I think it's an opportunity to showcase the broad and robust results from the REDUCE-IT study.
Anytime you have an ad comm, particularly in ad comm for the first class approval, we should expect that the ad comm covers the general topics of trial design, safety and efficacy.
But, they have a broad panel and broad panels usually also bring on a broad array of questions. So, we're trying to prepare for, questions that might be typically expected, but also, what else might be useful to audiences and we don't yet know who those panelists will consist of. But we do know from the data, from our review and the publication of that data in both the New England Journal of Medicine and the Journal of American College of Cardiology, that those who have looked at the data, the closest have concluded that the data is robust and significant and we're looking forward to an open and healthy, discussion of that scientific data.
Joel Beatty
I agree and physicians I've talked with have the overwhelming large majority have viewed REDUCE-IT results quite favorably once they’ve taken a closer look at the data. As with any study there are, tend to be a couple of push backs and one that comes up occasionally is on statin interaction. And, questions on whether the potential statin interactions, could have caused some of benefit that Vascepa showed. So, I guess I'm curious, are there any plans, that Amarin has to try to address that further or is the data already there to answer that question.
John Thero
Any time, a first type therapy comes out, it's healthy to have scientific discussion of that therapy and that's why we had the New England Journal of Medicine conduct a thorough peer review and it is why we presented these results now at multiple medical congresses. When we initially presented the results, I think the reaction from some and not those who are close to the study, but from some was geez, these results are too good to be true based upon triglyceride reduction. And this was last November.
Since that time, I've seen a lot of those who had that initial reaction come to appreciate that this was not a study about triglyceride reduction but rather this was a study about the multifactorial effects of Vascepa. Others have now might progress to a contrarian view of geez, maybe in some way the placebo arm of the study was active. I will remind people that this mineral oil we're using it is less than teaspoon per day. Mineral oil has been used for a century in much higher volumes and as people try to explain why these results produced because of mineral oil.
There's no data that we're aware of that suggest that mineral oil is anything other than inert, the event rate in the placebo arm of the REDUCE-IT study was consistent with, actually slightly lower than what we had reviewed with the FDA, prior to the start of the study, which would not suggest that the mineral oil was having any effect on event rates. And further in the design, I think a lot of this contrarian perspective is driven by people looking at certain lipid biomarkers in the study and saying, well, geez, LDL went up a bit in the placebo arm and it didn't go up in the Vascepa arm.
While the increases weren't all that pronounced even on the placebo arm. I remind people that in controlled studies for lipid biomarkers, there's data suggesting and mechanistic data suggesting that Vascepa should lower LDL on the fact that it didn't go down, means that it actually went up somewhat, which I'll come back to in a second.
But the broader point here is that, when we were designing the REDUCE-IT study with the FDA. And this was a study conducted under a Special Protocol Assessment agreement. We and the FDA agreed at the start of study that the biomarkers should not be secondary endpoints for the study.
And we had various approaches that we could take in designing of this study. We could try to control every variable, which we don't think would be consistent with the practice of medicine, or we could try to conduct a real world study where we had two blinded groups and treated to the standard-of-care, meaning that physicians could manage patients as they deemed appropriate for their cholesterol and for their diabetes and hypertension, et cetera.
And then when that happens, you have lipid markers that are going to likely bounce around. You've got various compliance issues and as you'd expect and we've seen in multiple studies reminding physicians and patients throughout the study that they need to stay compliant with their statin therapy as part of this kind of study and part of the reason for doing a placebo controlled study. Further, we had presented to FDA and FDA agreed before the start of this study that regression to mean was likely relative to these biomarkers. And particularly on something like LDL, the entry criteria for REDUCE-IT require that patients to get into this study, you had to have LDL levels below 100.
And the median LDL level in this study was 75. And we think that without any evidence of mineral oil being anything other than inert that what we're seeing in terms of some of the lipid biomarker moves are a reflection of. Regression to the mean and other natural and predictable patient related affects including compliance that appear to be balanced across the two arms of the study with a lack of decrease in LDL on the Vascepa arm, corresponding to a modest increase in LDL on the placebo arm.
But without any biological activity from LDL, which is the conclusion that FDA reached after its review of our first Phase 3 study, the MARINE study. And is consistent with the FDA's review of the ANCHOR study will conclude that the results of the ANCHOR study were truthful and non-misleading as presented. I remind folks that the active ingredient in Vascepa, which is stable. Eicosapentaenoic acid was studied in the JELIS trial in Japan. And while that's a Japanese-only patient population and it was essentially hypothesis generating for purposes of what we're doing.
There was no mineral oil used in that study, so clearly it wasn't mineral oil that was driving a result. So those who have looked at this data, the closest have been comfortable that the benefit demonstrated in the REDUCE-IT study is a benefit being driven by Vascepa and not by mineral oil. I appreciate that there's always contrarian that having scientific discussions of these matters is healthy.
We'll look forward to even broader discussion of this. And on our website under the Investor Relations section, there's a frequently asked questions section, it goes into these types of topics in even more detail but I'm quite satisfied as our scientific advisors that mineral oils inert, it didn't impact the overwhelming efficacy of the REDUCE-IT study.
Joel Beatty
Okay. Thanks for the explanation. Beyond the clinical review of Vascepa, there's a lot more going on in Amarin including ramping up the sales force to 800 reps, witness about a doubling of the sales force. Can you give us an update on the status of that?
John Thero
So we – this is a big opportunity to improve patient care. We envisioned launching based on a cardiovascular risk reduction indication. It was essentially surround sound and that includes an increase in our sales force. It also means speaker programs and medical education followed by direct-to-consumer promotion. So sales force that we have in place today is about 400 sales reps. They call on roughly 50,000 physicians, about 80% of that is general practitioners, about 12% of that's cardiologists, about 7% is endocrinologists. We're not calling on those physicians with adequate frequency at this point in time.
So as we moved to doubling our sales force, we will be certainly increasing the number of physicians we're targeting, but we won't be doubling the number of targets. We'll be moving to roughly 70,000 to 80,000 physicians with the idea of visiting them more frequently and being able to speak to them more directly of the results of the REDUCE-IT study.
And at this point, we've had thousands of applicants for those physicians. We've hired some people are really impressed by the quality of people that we've been able to hire. Part of the decision to go to 800 reps was based upon the feedback we've been seeing from physicians. But also from the results we've seen from some of the sales reps we hired at the beginning of 2019 where those reps are getting into docs who haven't been called on in the past and getting traction faster than what we were expecting, all of that convincing us that we should increase our sales force to 800 versus a more modest number that was originally our thinking.
Joel Beatty
Great. I think scripts and sales have roughly doubled over the last year or so. Can you give a sense of those, the growth in scripts are growing from existing prescribers or from new prescribers?
John Thero
That's growing from both, new prescribers and existing prescribers. We're seeing a lot of new prescribers, including many prescribers that we're not calling on. That being said, there's over 660,000 physicians who prescribe statin therapy and only a fraction of that are currently prescribing Vascepa. And as we do opinion surveys, we are finding that still many docs have very limited knowledge of Vascepa.
We're looking forward to the launch of Vascepa for cardiovascular risk reduction, changing that. While we are seeing more new physicians write Vascepa, the greatest increase in prescriptions is from our existing physicians, physicians who know that data the best and particularly the cardiologists are increasing their rate of prescribing at the fastest rate.
Joel Beatty
Got it. And earlier you mentioned about the surround sound approach to marketing Vascepa. My sense is that some of that may be contingent on getting the labeling at least in regards to that the timing of how you're able to implement that. Could you talk about a little bit about how quickly you're able to kind of go through these multiple approaches to marketing Vascepa?
John Thero
Sure. So with regard to the sales force, the aim is to have 800 sales reps in place at the time of a very quickly after the label expansion. So with an ad comm in mid-November, we assume approval in December, the aim would be to have that expanded sales force in place and trained by late December or early January for a launch really to start the new year. The same would be true relative to expanded medical education and some of the digital outreach programs and things.
The big other area of spending and I think probably the other area of greatest impact would be through consumer promotion of which we're doing really next to none of today. This very little sort of pilot programs based upon our current niche indication. And there it's a two-step process, we have to first get the label expansion for Vascepa. And then for consumer promotion, we do need that promotion to be separately approved by the OPDP, which is a promotional division within FDA.
We're assuming that that process will take roughly five to six months. So as we think about our opportunity for education and growth, we would think of, the first inflection upcoming from the label expansion, the promotion from our sales force and some of our other direct activities. And then another inflection, roughly six months later when we are able to more broadly do a consumer program.
The pilot testing that we've done on consumer promotion has been very positive. I think there's cardiovascular disease is one of those paradoxes where it's the most expensive area of healthcare spending. And also the number, largest contributor to death more than all cancers combined in the United States. And yet, because there really hasn't been any major breakthrough therapy beyond cholesterol management, diabetes drugs in decades.
It doesn't get a lot of attention. And when we get out and remind people of the significant risks that exist beyond those therapies. And we're not trying to detract from those therapies, those therapies are terrific. But remind patients of that, there's a sense of awakening that occurs and a sense of wanting to find out what they can do to address that risk is that sort of out of the public consciousness these days. So we're very much looking forward to the educational opportunities that consumer promotion will provide. But again, that's roughly five to six months after the label expansion.
Joel Beatty
Got it. You touched on the large burden of cardiovascular disease in the U.S. but from a morbidity and mortality standpoint, it falls from cost. And over the summer, related to the ICER conducted a review, at least released a preliminary report stating that Vascepa is quite cost-effective, even if the price were higher than where it's at now, does that support that there's room to go up on the price of Vascepa?
John Thero
So we envision that there will be multiple groups that will do pharmacoeconomic analysis of Vascepa. I've been told that it's rare for somebody to get a favorable analysis from ICER and still complaint because a very few drugs get across the board, thumbs up from ICER on all their analyses. But I do think that ICER understated the economic savings that can be attributable to Vascepa. And we look forward to their final report as well as some other analysis that might be coming on that particular topic.
The managed care coverage for Vascepa is already pretty good approval rates for Vascepa is around 80%, which is consistent with generic Lovaza at this point. Our price of Vascepa is similar to where Lipitor atorvastatin was before went generic lower than say, Crestor rosuvastatin, both of those statins billions of dollars in revenues.
And I think, this is much more of a volume opportunity than it is a pricing opportunity. And we think by making our drug affordable, both managed care as well as the patients. and patients with insurance you can get Vascepa today for about $3 per month for the copay card provides great solution for society. I hear a lot of discussion in Washington these days about, how do you address your healthcare issues and people talk about the need for medical innovation. They talk about the need for preventative care, they talk about the need for outcomes based medicine and they talk about the needs for affordable therapy.
And we’re proud that Vascepa checks all those boxes and hope that by having a product that is affordably priced that, to the extent that Vascepa isn’t already covered by medical insurance, that insurers are moving rapidly to cover Vascepa, once we have the label for cardiovascular risk reduction.
Joel Beatty
Great. So there’s the STRENGTH trial of Epanova ongoing, it seems like results from that trial will be released about a year from now. What could the impact of the results from that trial before mainly for Vascepa.
John Thero
So I hope that trial is successful. History suggests that when you’ve got multiple players in the marketplace that helps expand your market penetration faster. They are studying a patient population that’s a bit riskier than the population that we’re studying in – we studied in REDUCE-IT. They’re studying patients who had higher levels of triglycerides and we studied as well as low HDL and that subgroup, and REDUCE-IT and we had a 38% relative risk reduction.
The two drugs are different. I think we’ll have to wait to receive the results of that drug in trial before concluding entirely. Historically, drugs that are mixtures of DHA and EPA haven’t worked, but they are studying in at-risk enough patient population that it’s a good chance that they will succeed. I’d be surprised if they exceeded 38% relative risk reduction, look forward to seeing the results, they have results next year. It’s probably not for another, somewhere in 2022 that they’d be come into the market.
Joel Beatty
You mentioned 38% relative risk reduction.
John Thero
In the pre-specified group in REDUCE-IT study with trigs of 200 or greater and low HDL, which was sort of analogous to what they’re studying. We had a 38% relative risk reduction in the REDUCE-IT study. That’s correct.
Joel Beatty
Okay. There’s other lipid lowering drugs focused on the LDL space that are launching or could be launching soon, including Esperion’s bempedoic acid, medicines companies, inclisiran and a couple of other PCSK9s. How do physicians think about if multiple drugs are needed. Is there any impact on how they think about prescribing Vascepa?
John Thero
So lower is better in terms of LDL and patients can’t be controlled with statin therapy, they should be looking for other therapies to lower LDL. And I think the LDL space is well known by physicians and by payers and it’s terrific. We are not trying with Vascepa to replace LDL management rather we are looking to compliment LDL management. So in our REDUCE-IT, we studied patients who had well controlled LDL, medium baseline of 75. In general, those are not patients who would be targeted by those new therapies that we’re referring to in the question.
So we’re hoping those therapies do well. We want to improve patient care and I think physicians will be able to sort through the need both managed LDL cholesterol, but also to address the broad cardiovascular risks that exists beyond cholesterol management. So hopefully Vascepa we used hand in hand with those therapies. I do think that the positioning of Vascepa is one that is certainly intended for much more mass use than say some of the PCSK9 that are out there today.
Joel Beatty
Great. For manufacturing, what is Amarin doing to increase capacity and what sort of revenue potential are you designing manufacturing capacity to be able to support?
John Thero
So regarding the letter, we’re working to be at a support multiple billions in revenues and we’re using a strategy that has multiple suppliers competing against themselves. We saw an earlier generation product, where they had a single supplier of that, at least in our view didn’t by having a single supplier, it didn’t challenge that supplier to stay current and the most efficient in its processes.
So by having multiple suppliers, we’re challenging those suppliers to increase efficiency. We continue to lower price, but also to increase volume. We came into 2019 in a position whereby if all of our – if we’re purchasing all of the capacity that our suppliers could produce, that we could have supported revenues this year of about $1 billion. That wasn’t our guidance. Our guidance coming into the year was revenues and about $350 million, we’ve subsequently increased that guidance to $380 million to $420 million for this year.
In parallel, we have been working with our suppliers and they are on track to being able to support significant multiples of the $1 billion in capacity that we came into this year with the while hoping to also continue to improve, albeit modestly the efficiency of production. This is a challenging product to manufacturer, once you’ve mastered it, repeating it’s relatively straightforward, but it is not a simple product to manufacturer, fortunately, we’re dealing with some terrific companies and they’ve been investing in manufacturing capacity expansion, while continuing to have very strong quality.
So we’re aiming to get to billions there are some higher – there’s a broad range within the billions that we have potential scenarios for and I’m not going to directly quantify those at this point in time. We’ve only given like quantified guidance on our revenues for this year.
Joel Beatty
Got it. So in the near-term, it sounds like manufacturing capacity is increasing quite a bit already. So what’s realistic in the longer term for Vascepa revenues? I think occasionally some of the highest estimates reach as high as let’s say $10 billion in revenue for Vascepa. Is that something that’s realistic? Is there a path to get there?
John Thero
We do hear those numbers and I have done or had various quantitative analysis done that have a range of scenarios that would include numbers in that ballpark. At this point in time, that’s not our guidance. We’ve only given guidance for this year. We don’t even have a label yet for cardiovascular risk reduction. We do think that’s the opportunity here is in multiple billions of dollars as to whether it’s, $10 billion or not. I think it’s a little premature to be providing guidance there. But this is a very large opportunity and we are positioning ourselves that if the demand is that high that we’ll get there.
Joel Beatty
Great. So assuming Vascepa is a peripheral cardiovascular risk reduction indication, how does Amarin prevent dietary supplement companies from claming other products have the same effect on patient health?
John Thero
So during the 10 years that we’ve been developing Vascepa, we’ve seen a lot of failures along the way. We started off and thought that, they’ll see DEP inhibitors would be competing for cardiovascular risk reduction. We thought that niacin and fenofibrates and we’d be competing and what’s happened along the way, they’ve failed, but in also Lovaza, which is a Omega-3 mixture, be a prescription has now failed multiple outcome studies. And dietary supplements, despite now for since the 70s saying that they may reduce cardiovascular risk, I’ve repeatedly failed and outcome studies.
So they’re sometimes we used to keep saying, you may – you don’t prove it, it becomes much more questionable whether you actually do, there were two major meta analyses on a Omega-3 products last year. There were mixtures in one by Cochran and one the other ones published in JAMA, both showing that they don’t work. Just two months ago, the FDA responded to the action request by the lobbying firm for dietary supplement industry, where the supplement industry looking to be able to make medical claims relative to dietary supplements.
And the FDA responded resoundingly that there was no data to support those claims if the data was inconclusive and inconsistent. So I think what is needed is education, people have been hearing, you know, for too long that dietary supplements might work, you know, dietary supplements as a reminder. Our food, they’re not drug, they’re not intended to be treating any medical conditions, but there has been no drug approved for that.
Once we are approved, I think there will be an opportunity for consumer education and fortunately that the facts are in front of us. There’s a place in the world for dietary supplements, but not for treating patients who are at risk. The American Heart Association recently provide that same advice, which is that patients who are at risk and not be treated with a dietary supplement.
Vascepa has mechanism of action, which is unique. FDA is deemed it to be a new chemical entity. It works, again, our website, we’ve got a couple of dozen papers on the mechanism of action for Vascepa and how it’s different than other Omega-3s and we’ll be looking forward to educate people on that science and particularly a differentiation that exists through cardiovascular outcome studies where we’ve succeeded and they failed.
Question-and-Answer Session
Q -
Joel Beatty
Great. This is it. It looks like we are short on time. Thanks very much for the conversation.
John Thero
Thanks, Joel. Appreciate the questions. And thanks everybody who were here for listening and participating. Thank you.
