Ascendis Pharma A/S (NASDAQ:ASND) Q3 2019 Earnings Conference Call - Final Transcript
Nov 18, 2019 • 04:30 pm ET
Thank you. [Operator Instructions] And our first question is from Jessica Fye with JPMorgan. Please go ahead, your line is open.
Hey guys, good afternoon. Thanks so much for taking my questions. First one is on manufacturing. I think you previously mentioned that you are expanding your manufacturing capacity in order to ensure you have enough drug supply for the launch. Can you just provide a little more of an update on the manufacturing progress and your confidence level that you have enough in place to be ready for the launch.
Thanks, Jessica. What we're doing now is actually not really affecting our launch because we already have the capacity really to work and provide necessary material for entire launch space and we basic already are manifesting on the high-speed on every day. We really can do, just really to build up as much as possible TransCon Growth Hormone that can go out to the patients.
What we more or less are really building up the secondary supplier is what we call the global reach, because we now really are implementing clinical trials for rest of the world to ensuring we not only addressing a US population but really expanding the TransCon Growth Hormone to be available basic on a global basis. And this is why, we are expanding the capacity and the capacity is build up in such a manner where we starting to get true, what I call the clinical operation, the clinical approval process for rest of the world. We will be in a position that we also have sufficient manufacturing capacity.
So to make it very short, the expected capacity is not really mainly focused on the US market, is mainly build up to have global capacity.
Okay. And then, I know, you recently got orphan drug designation in Europe for TransCon Growth Hormone and there has been some debate among investors about the regulatory requirements in Europe related to PEGylated products in children. So how much can we or can't we read into the orphan drug designation as kind of a good sign on that front. Did the European Commission review any data in granting that designation, or was it more just based on the market size and the potential for benefit over existing therapies without a specific read on the data?
Sure. They're reviewing our data because we sending in application that describing the concept of our product compared to the clinical data we have achieved. From that perspective, I think, what we're recognizing is basic -- is that we are in a position that we really have a product opportunity that is really from an initial group, it also see it adding a benefit to the patient, and that is where we are, we are still in a continuous dialog with the European authorities. And just to recap that discussion is that we feeling pretty confident, we are coming as one of the first company at dedicated pediatric development plan, have always developed with