AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Q3 2019 Earnings Conference Call - Final Transcript
Nov 01, 2019 • 08:00 am ET
[Operator Instructions] Our first question will come from the line of Ami Fadia with SVB Leerink.
Thank you I have a couple of questions but I'll limit them to 3. Firstly for Julie what type of study do you think is feasible to help provide the substantial evidence of efficacy from Makena? If you could sort of provide us with current thinking could it be a RCT study or some sort of a registry study if you could elaborate on that and also give us a sense of the cadence for discussing next steps with the FDA and what could the time lines around that be?
Julie Krop, M.D
Yes good question. I mean we obviously need to discuss this with the FDA. As far as study design we're proposing -- we're committed to proposing a variety of different types of studies. I think the key is that we want to make sure we are able to as you said fulfill the need for substantial evidence. I think that can be done with a combination maybe of some PK/PD studies along with some prospective collected data for more observational type studies. But we're also prepared to do a randomized clinical control trial if that is what is decided. But this has to be obviously in combination with FDA. As far as next steps and timing it's hard for me to answer the question because we haven't sat down yet and have the discussion with the FDA. I think it's not going to be quick and it's not going to take forever. So sometime in the I would say -- and it's not going to be in the weeks but more a few months sometime in that time frame we'll have a much better idea I think of their -- where the timing will be.
Okay okay. Maybe the next question is for Bill. Can you elaborate on some of the types of options or alternative courses you're exploring to maximize shareholder value especially in the scenario where Makena may have to be taken off the market?
William K. Heiden
Yes. Thanks Ami. We certainly don't believe that is going to be the scenario but we are fully prepared for that and we thought through a variety of different scenarios. We've -- there are a number of different ways that we can approach us but I will tell you some of the things we are actively working on today which is ex-U.S. partnerships for some of our exciting development programs. I mentioned Ciraparantag AMAG-423 and other good example where there is interest to partner outside the U.S. And so I think that's an opportunity to maximize value of the products that we have in our portfolio in the near-term and so that's something that we're focused on today.
Would you consider something more kind of different with regards to maybe exploring partnership or monetizing some of the assets in the U.S.?
William K. Heiden
Certainly we're open to a number of different options. I think you may have seen that we