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Wednesday, June 04, 2014 11:16:10 AM
by Matthew Herper
Fish oil: “We didn’t pay a lot of money for this thing, right?”
Matthew: One thing you purchased was the fish oil product, Omthera. If there is such a thing as great fish oil product, it looks to be a great fish oil product. Do you have NCE (New Chemical Entity designation) on it?
Pascal: Not yet. The problem is because Amarin has launched a legal case. Basically, I don’t think we’ll know about the NCE status until that Amarin case is settled.
Matthew: What makes you confident that a fish oil will do well, especially given all the meta analyses and the flood of data saying that at relatively good doses, you’re seeing no benefit on heart attacks and strokes?
Pascal: First thing is to keep in mind is we didn’t pay a lot of money for this thing, right? The upfront money was limited. Essentially, the idea was it’s going to pay for itself if we market it only in the high triglyceride patients. If we actually get an indication and show benefit in the lower triglyceride population, so mixed dyslipidemia, then it’s going to be big. If I start with the high triglyceride, more than 500 milligrams per deciliter, there is a very strong synergy here because most of those patients are treated by endocrinologists, lipidologists. Those are physicians we visit for our diabetes franchise. I think we can certainly do relatively well in that population. Of course, it’s limited. Now if you move to this mixed dyslipidemia… It’s a scientific question of course, so there is a lot of debate around whether it’s going to work or not.
Matthew: Are you committed to doing the outcomes trial to prove it can prevent heart attacks and strokes? You’re not going to pull funding for the outcomes trial? You’re going to do it?
Pascal: I happen to believe it has a good chance of succeeding. I’ll tell you why. It’s that first of all, people look at triglyceride studies across the entire population. They look at fish oils, if you want, at different doses. First of all, you have to have the right dose of omega-3, you have to have the right mixture and secondly, you need to have the right patient population. Those patients, they have to have triglycerides at least above 150 milligrams per deciliter. It’s clear that you can’t show a benefit below this level.
If you look at the analysis the FDA did, and that is a public analysis, if you look at the patients that have triglycerides above 150 and low HDL. They have to have a low HDL and triglycerides above 150… there is reason to believe that it would work on that population. If it works, then the opportunity is quite large.
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