KERYX ANNOUNCES REVIEW OF FIRST INTERIM ANALYSIS FROM PHASE II/III CLINICAL PROGRAM FOR KRX-101

Keryx Biopharmaceuticals has announced that the Collaborative Study Group has recommended the company proceed to the Phase III portion of its Phase II/III clinical program of KRX-101 for the treatment of diabetic nephropathy, as planned.

This recommendation is based on the completion, by an independent data safety monitoring committee, of a safety evaluation of the first interim analysis from the approximately 150-patient, randomized, double-blind, placebo-controlled Phase II clinical trial of KRX-101, and an efficacy assessment of the same data set conducted by the CSG.

Pursuant to this recommendation, and subject to Keryx's successful finalization of its clinical plan with the FDA, Keryx expects to begin its pivotal program, including both Phase III and Phase IV studies for KRX-101, within approximately the next three months.