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Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
Date:12/5/2007

No Safety Concerns Raised

Sulodexide Phase 3 study to continue without modification

NEW YORK, Dec. 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals (Nasdaq: KERX) today announced that the Independent Data Safety Monitoring Committee (DSMC) responsible for monitoring Sulonex(TM) (sulodexide oral gelcaps), the Company's lead drug candidate under development as a treatment for diabetic nephropathy, recently met to evaluate the data from the ongoing Phase 3 trial. Following a complete review of all available safety and efficacy data, the DSMC found no cogent reason to recommend alteration or termination of the Phase 3 trial. The DSMC raised no safety concerns regarding Sulonex or the trial. As planned, no review was conducted of the safety and efficacy data from the Phase 4 trial during this meeting.

Prior to this most recent meeting, the DSMC had previously convened in November 2006, in March 2007 and in August 2007 to review data from the Phase 3 and Phase 4 studies. At each of these meetings the DSMC raised no safety concerns.

On June 18, 2007, the Company announced the completion of patient randomizations into the Phase 3 portion of the clinical registration program. The Company anticipates that the last patient will complete the active treatment period in mid-December 2007 and the two month off-treatment period in mid-February 2008.

ABOUT THE SULONEX(TM) PHASE 3 and PHASE 4 CLINICAL PROGRAM

Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. These trials are being conducted by the Collaborative Study Group, the world's largest standing renal clinical trials group. '/>"/>

SOURCE Keryx Biopharmaceuticals
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