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John Thero

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rafunrafun   Wednesday, 09/11/19 11:11:55 PM
Re: oneragman post# 213890
Post # of 214463 
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.


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