Keryx Biopharmaceuticals (KERX) Announces Presentation of Two Abstracts at ASCO 2010 Annual Meeting

NEW YORK, May 21 /PRNewswire-FirstCall/ — Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX – News) today announced that two presentations on clinical data from KRX-0401 (perifosine), the Company’s novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be made at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will take place at McCormick Place in Chicago from June 4-8, 2010.

Updated clinical trial results will be presented during the following poster discussion sessions:

Pediatric Oncology

Abstract Title: Phase I study of single-agent perifosine for recurrent pediatric solid tumors.

Presentation Date/Time: Sunday, June 6, 2010; 2:00 PM – 6:00 PM with poster discussion from 5:40 PM – 6:00 PM

Author: Oren J Becher, MD,  Memorial Sloan-Kettering Cancer Center

Discussion Presenter:  Mark Kieran, MD, PhD,  Dana-Farber Cancer Institute

Permanent Abstract ID: 9540

Location: S Hall A2, Poster Board #42b, with discussion in S504

Gastrointestinal (Colorectal) Cancer

Abstract Title: Final results of a randomized phase II study of perifosine in combination with capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with second- or third-line metastatic colorectal cancer (mCRC).

Presentation Date/Time: Tuesday, June 8, 2010; 8:00 AM – 12:00 Noon with poster discussion from 11:45 am – 12:00 Noon

Author: Donald A. Richards, MD, PhD,  Texas Oncology

Discussion Presenter:  Wells Messersmith, MD,  University of Colorado

Permanent Abstract ID: 3531

Location: S403, Poster Board #22, with discussion in S406

Abstracts can be accessed through the ASCO website, http://www.asco.org/.

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 1 and 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 being conducted pursuant to 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 trials and business prospects for KRX-0401 (perifosine), 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 KRX-0401; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; 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 undertake 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 found on our website and the ASCO website is not incorporated by reference into this press release and is included for reference purposes only.