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Präsentation für Donnerstag, 10. Januar um 09.00 Uhr PST Geplante
Press Release : Keryx Biopharmaceuticals, Inc. - vor 9 Stunden
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NEW YORK, 7. Januar 2013 / PRNewswire / - Keryx Biopharmaceuticals, Inc. ( KERX ) gab heute bekannt, dass Ron Bentsur, der Chief Executive Officer, wird am 31 präsentiert st Annual JP Morgan Healthcare Conference, gehalten 7. Januar -10, 2013, in San Francisco, CA. Mr. Bentsur Präsentation findet voraussichtlich am Donnerstag, 10. Januar th , am 09.00 Pacific Standard Time (12.00 Uhr EST).
Ein Live-Audio-Webcast der Mr. Bentsur Präsentation zugänglich sein wird von dem Investor Information-Seite der Website des Unternehmens unter http://investors.keryx.com . Eine archivierte Version des Webcast wird nach dem Abschluss der Live-Präsentation.
Über Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals ist auf die Akquisition, Entwicklung und Vermarktung von medizinisch wichtigen pharmazeutischen Produkten für die Behandlung von Nierenerkrankungen konzentriert. Keryx entwickelt Zerenex (Eisencitrat), ein oral, Eisen-III-basierten Verbindung, welche die Fähigkeit, sich an Phosphat und nicht-resorbierbaren Form Komplexe binden. Die US-amerikanische klinische Phase-3-Programm Zerenex für die Behandlung von Hyperphosphatämie (erhöhte Phosphatwerte) bei Patienten mit end-stage renal disease wird gemäß einem Special Protocol Assessment (SPA) Vereinbarung mit der FDA durchgeführt. Zerenex ist auch in Phase 2 der Entwicklung für das Management von Phosphor und Eisen-Mangel bei anämischen Patienten mit Stufe 3 zu 5 nicht-Dialyse abhängigen chronischen Nierenerkrankung. Darüber hinaus hat Keryx japanischen Partner, Japan Tobacco Inc. und Torii Pharmaceutical Co., Ltd ihre New Drug Application für die Marktzulassung von Eisencitrat eingereicht in Japan zur Behandlung von Hyperphosphatämie bei Patienten mit chronischer Nierenerkrankung. Keryx ist in New York City.
Keryx CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965 E-mail: lfischer@keryx.com 212.531.5965
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Ich weis es nicht, ob News kommen. Stell nur Info's ein, wenn ich was finde.
Ansonsten laufen lassen.
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.