From Goldman, June 12th.
Unidentified audience question -
John, could you comment on, there’s been some talk about generic competition or challenging your pattent, could you talk about your strategy there? And also, the production of Vascepa and what type of limits there are out there for you and for others?
John Thero
Yes. So, the question pertains to ANDA filers. This is out in the public record. There were four ANDA filers. One of those, Apotex removed themselves from the process and one of those is Teva. We did reach a mutual agreeable settlement with Teva that they could enter into the market in the second half of 2029, which is a little lower 10 years from now. There are two remaining filers that we have gone beyond the Markman hearings, which I think went largely, almost entirely in our favor. This is the claims construction hearings. More recently, we have been, the court has allowed us to introduce the results of the REDUCE-IT study and as which we believe are supportive of the uniqueness of Vascepa.
There is a court date scheduled date scheduled for opening hearings on January 13. If it goes to court, probably have a decision 2 to 3 months. After that we’ve asserted 14 of our Orange Book listed patents. They all have expiries in 2030. They all have multiple claims, and we intend to defend those patterns vigorously. This is a unique feel. This is not a drug that’s easily manufactured.
There is Lovaza out there, which is GSK's drug, which I think some of the generics on there probably have lost money because it's been difficult to manufacture and they’ve had some shortages over time with that drug. Our suppliers have spent tens of millions of dollars and with their expansions, I'm sure it will get up over to the multiple hundreds of millions of dollars investing in supply capacity and efficiency. You know the belief that we’re going to grow Vascepa in a multiple billion-dollar opportunity and of course Vascepa is more difficult to manufacture then is Lovaza.
So, we’ll see what happens relative to the end of litigation. I can't make any predictions there, other than stating that we intend to defend our patents vigorously, and we like our IP.
Unidentified Analyst
John, my question is sort of leading though, even if somebody does, you don't have some patent success, which seems unlikely. My question is, would they be able to produce them? Because it seems like you’ve locked up supply out there?
John Thero
It’s a very difficult product to manufacture. Again, it’s easier to manufacture than this product. People have had difficulty manufacturing that. The suppliers that are working with us are working with us on an exclusive basis. It’s not clear to us where others would get supply from or if they would be wanting to spend or who would want to be spending that level of investment to grow that level of manufacturing given a revenue base that right now is about 350 million is our target for this year.
We are investing with our suppliers into manufacturing expansion with the idea that we will continue to grow the market and often when something goes to generic doesn't grow, with the idea, it is going to be multiple billions in revenues, but whether somebody else would put that level of investment in or not, I can't speculate. That would be up to them, but it would not be an easy or an expensive path.
I think my clock is a run out. I thank you for your interest.
