AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) Q3 2019 Earnings Conference Call - Final Transcript
Nov 01, 2019 • 08:00 am ET
Edward Ted Myles
to providing financial guidance to the investment community in January.
With that I'll turn it back to Julie for a quick update on our development programs. Julie?
Julie Krop, M.D
Thank you Ted. As you know we have 2 development stage assets in our portfolio. Ciraparantag is a small molecule designed to reverse anticoagulation in patients who have an urgent or serious bleeds will require emergency surgery while taking anticoagulant therapy. We are currently in the process of working with FDA to gain alignment on the design of the next clinical trial. The proposed study will measure whole blood clotting time using an automated coagulometer developed by Perosphere Technologies. Before study initiation the coagulometer must be clear through an Investigational Device Exemption or IDE and then Perosphere Technology will submit the IDE once the design for the next study is finalized.
The extra time we spend now will help ensure that the data we generate will allow us to have a successful end of Phase II meeting which we plan to schedule after the study completion. Regarding our other development program AMAG-423 which is being developed to treat pregnant women with severe preeclampsia an orphan condition with high unmet medical need enrollment of the Phase IIb/IIIa efficacy and safety study is ongoing and we look forward to updating you when the enrollment is complete. Bill?
William K. Heiden
Okay. Here on our final slide I just want to wrap up with a summary of areas of focus for the company as we look ahead. For Makena it's continuing to capture the majority of this market with the subcu auto-injector and also follow-up with the FDA to agree in a path forward that will generate the requisite additional data and ensuring that physicians and patients continue to have access to Makena. As Tony covered we're encouraged by the early Vyleesi launch metrics and look forward to continuing to report the progress on this new product's launch trajectory. Feraheme performance has been strong quarter-on-quarter and the team is focused on continuing that growth. We're opening new sites and working to continue to enroll patients with severe preeclampsia in the 423 clinical trial. We're also working closely with Perosphere Technologies to submit the automated coagulometer Investigational Device Exemption and initiate the next Ciraparantag clinical study in healthy volunteers as quickly as possible. And finally continuing to focus on optimizing the value of our portfolio to maximize shareholder value for example exploring an ex-U.S. out-licensing opportunity for Ciraparantag.
And so with that let me stop with our prepared remarks and we'll open the call for questions. Regina?