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Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of Zerenex (ferric citrate) at National Kidney Foundation (NKF) 2010 Spring Clinical Meetings

Tuesday, April 13, 2010 General News
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Long-term data to be presented suggest that use of Zerenex may also potentially reduce the need for intravenous iron and erythropoietin in hyperphosphatemia patients on dialysis
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NEW YORK, April 13 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that several posters on Zerenex™ (ferric citrate), the Company's iron-based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease who are on dialysis, have been accepted for presentation at the National Kidney Foundation (NKF) 2010 Spring Clinical Meeting taking place April 13-17, 2010, in Orlando, Florida.
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The following posters will be presented tomorrow, April 14, 2010, from 6:00pm-7:30pm:

  • LONG-TERM USE OF FERRIC CITRATE IN ESRD PATIENTS
  • THE SAFETY AND TOLERABILITY OF HIGHER DOSES OF FERRIC CITRATE (FC) IN CONTROLLING SERUM PHOSPHORUS (P) IN ESRD PATIENTS
  • IRON ABSORPTION WITH HIGHER DOSES OF FERRIC CITRATE IN CONTROLLING SERUM PHOSPHORUS IN ESRD PATIENTS
The Company's Phase 3 clinical program of Zerenex as a treatment for hyperphosphatemia in patients with end-stage renal disease who are on dialysis is pending commencement under a Special Protocol Assessment (SPA) agreement with the FDA.

Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc.  The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 2 clinical development for several other tumor types.  Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA.  Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical and business prospects for Zerenex (ferric citrate), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for Zerenex; the risk that the data (both safety and efficacy) from the Phase 3 program will not coincide with the data analyses from the Phase 2 clinical trials previously reported by the Company, including the effects on IV iron and erythropoietin use observed in the long-term safety extension trial; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.

CONTACT:  Lauren Fischer, Director, Investor Relations, Keryx Biopharmaceuticals, Inc., +1-212-531-5962, [email protected]

SOURCE Keryx Biopharmaceuticals, Inc.

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