Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) Q1 2018 Earnings Conference Call - Final Transcript
May 10, 2018 • 08:30 am ET
Thank you. (Operator Instructions). We'll go first to David Amsellem from Piper Jaffray. Please go ahead.
Thanks. So just a couple. So regarding RYANODEX in EHS, I know you've talked about this a lot in the past but can you just walk us through, if you can, the process that led you to basically run the same study that you did previously? It seems that it was highly iterative and then it got you basically back to just doing the same study. So I'm just trying to get a window into what the FDA was thinking and the extent to which you are on the same page with the agency regarding the path forward? That's number one. And then secondly on ANDAs, particularly the one that you haven't filed. Can you provide any color on the competitive dynamics around that product? Is that a potential first-to-market opportunity or limited competition opportunity? That would also be helpful. Thanks.
Thank you, David. Two very interesting thoughts. But, first on EHS, you're right. We received a complete response back in July and we've always -- we've had some conversations. We've always believed that we did what we were required to do. I think at the end of the day it is really simple after having discussions with the agency and the back and forth, I think it really just comes down to an acknowledgement that we did what we needed to do and perhaps where we landed here is, a, we see it but we preferred not more than 34 subjects and why don't we get to more subjects. And we all concluded that the best way to do it was go back to the Hajj. And you're right, the two trials, the one we ran in '15 and the one we're about to run in '18 are almost identical. And I think it's just an acknowledgement that we wanted more than the 34 -- if you remember we originally wanted 100. Maybe we'll between the two look at closer to that. Hopefully we'll get back to the 100 here that we thought. We'll just have to see how it goes and then get back to the FDA.
But to answer the other question, you think that we're aligned, yes. We've had several meetings. The last meeting was very positive and we believe that there is an agreement between the agency and Eagle to what needs to be done. And hopefully we'll go collect the subjects. And then as it relates to the second ANDA, I can give you a little bit more color. The second one does not require Paragraph 4. It's an older generic that's been in the market for many years and there's just only one competitor. It's a hard drug to develop. It requires a pilot study. The size of the drug is a little bit under $200 million and we'll start that study here reasonably soon. And as soon as we conclude the biostudy and assume that we pass,