was sie gesagt haben Keryx Biopharmaceuticals' CEO Presents at 31st Annual J.P. Morgan Healthcare Conference (Transcript)
January 10, 2013 | about: KERX
Keryx Biopharmaceuticals, Inc. (KERX) The 31st Annual J.P. Morgan Healthcare Conference Call January 10, 2013 12:00 PM ET
Matt Lowe - JP Morgan
Welcome, everybody. My name is Matt Lowe with the JP Morgan Biotech team. Our next company to present is Keryx Biopharmaceuticals. We will have a breakout afterwards in the Yorkshire Room. If I could just ask everyone to please turn their cellphones on silent for the presentation.
And without further ado, I will hand over to the CEO, Ron Bentsur. Thank you.
Ron Bentsur - CEO
Thank you very much. I want to thank JP Morgan for inviting us to present at this very important conference, and I want to thank you all for attending. With no further ado, I will go into the presentation. I will be making, however, some forward-looking statements. So I do encourage anyone who’s interested in the company to read our publicly available disclosures from the 2011 10-K and from the third quarter 2012 10-Q, and in particular the risk factors that appear in those documents.
So, with Keryx, we’re talking about a product called Zerenex. Many of you, obviously, are familiar – very familiar with the story. I can look around the room, and there are a lot of familiar faces here, but there are also, maybe some of you that are new to the story. So, we’re talking about a product called Zerenex, it’s comprised of ferric citrates, so it’s an iron-based phosphate binder, for the treatment of hyperphosphatemia or elevated phosphate levels in dialysis patients. The Phase III program, in end-stage renal disease, these are patients on dialysis, is being conducted pursuant to a Special Protocol Assessment.
The top line data, from the long-term Phase III study, which is the last remaining piece, under the obligation per the SPA, before we can file the NDA in the U.S. and MAA in Europe, the top line data from the study should be available any day, any week now. I’ve been advised by our clinical team that we’re really at the tail-end of the process. This is all in the hands of the CRO, we do not have access to the data, we have not seen the data and we just have to let the CRO do their thing, run their process and we will get the data when it’s completed. And as I mentioned, once we have the top line data, we will do our utmost to file the U.S. NDA and the European MAA as soon as possible thereafter.
This week was actually a very exciting week for us because our Japanese partner for Zerenex, Japan Tobacco, Torii announced that they filed their new drug application in Japan for Zerenex in chronic kidney disease, which includes both dialysis and predialysis. And this filing is based on several successfully completed studies in both of these areas, dialysis and predialysis. And obviously, we’re extremely excited by this announcement.
This filing also triggers a $7 million payment to us and just to shed a little bit of light on the Japanese phosphate-binder market, currently it’s about $350 million, growing at about 6%, 7% year-on-year. And in terms of the partnership that we have with Japan Tobacco, we still have $65 million in remaining potential milestone payments, and we’re also due double-digit royalties from sales that they generate in Japan. So, we’re very excited and we congratulate our partner on this tremendous accomplishment. |
Thread abonnieren
