News 
Market Data 
Discover
Replies to post #378852 on Amarin Corp Plc (AMRN)
05/30/22 8:54 PM
Q: Interesting, that's very helpful. And then as focus continues on driving Vazkepa European contribution to top line growth and prospective future revenue guidance, possibly down the road, can you talk about business development prospects, such as the fixed dose combination, Vascepa and statin therapy, the necessary steps there and the specific opportunity that could present.
A: So, first of all, we're really focusing on the launch of the mono, right, on Vascepa, because you know the value that will be created for a fixed dose combination is part statin and part Vascepa, so you really have to have a successful Vascepa launch and that's the number one priority today. Having said that, a fixed dose combination development is not a one year, right, it's a two to three year process. So, in your first year you do formulation and bio equivalence, second year you do your stability study, and third year you file. So that's really the runway more or less for the US. In Europe, it can be slightly longer because European agencies require more clinical data to be in the file. But having said that, this is going to be a very significant contributor for future growth. This is going to be one product that is going to have the highest cardiovascular risk reduction in one pill, right, in one product, because between the statin at 35% relative risk reduction and ourselves at 25 you are at 60 plus relative risk reduction, so those patients who will be taking this combo, this fixed dose combination, they should feel very confident that their cardiovascular risk is quite sort of under control.
Now you know beyond just the benefit for the patients, and you know the simplest is simple adherence, and there are so many benefits commercially of having a fixed dose combination because it's a true proven way to extend the life cycle of the product. So for, you know, in Europe today, we have regulatory exclusivity until 2031. A fixed dose combination that is filed with new clinical data, and we don't mean outcome, you know your typical twelve week lipid type studies, will have additional, can potentially have additional exclusivity,
maybe three years. So launching a fixed dose combination helps us extend the life cycle of the product, especially in Europe. But also, for the US it provides to us an opportunity maybe to come back to the market with a branded product that can potentially be protected because of its technology. Because the technology to manufacture a fixed dose combination is not accessible for everyone. And it is an expensive technology, so you know the cost of accessing the market is very high. But we'll have to see where the price of Vascepa monotherapy will be at the time of launch because that's going to be very determining whether we launch or not in the US.
Q: And then do you feel there's any sense of an impact on the branding with the...
A: Well, in reality, in Europe for example the brand will be in full growth mode. In reality, what you do is you amplify the growth of the mono. Some people may think you will cannibalize the mono, but you will cannibalize it very positively, meaning you're bringing in an additional tried and tested statin along with your own new product, and what it does it usually adds 2 to 3% to your penetration rate, because it gets far many more physicians who use the statin who have not used Vascepa to be basically users early on in the process, compared to later on.
AI
