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Keryx Biopharmaceuticals Announces that the SUN-MICRO Phase 3 Clinical Trial Failed to Meet its Primary Efficacy Endpoint
Date:3/7/2008

ngs, interim results of preclinical or clinical studies do not necessarily predict their final results, and acceptable results in early studies might not be obtained in later studies. Drug candidates in the later stages of clinical development may fail to show the desired safety and efficacy traits despite positive results in initial clinical testing.

Additionally, as indicated in previous filings, there can be no assurance that the results from the Sulonex Phase 3 study will track the data from the pilot Collaborative Study Group Phase 2 study or the DiNAS Phase 2 study. Results from these earlier Sulonex studies may not be indicative of results from future clinical trials and the risk remains that the pivotal program for Sulonex may generate efficacy data that will be insufficient for the approval of the drug, or may raise safety concerns that may prevent approval of the drug.

Some of the statements included in this press release anticipating future clinical and business prospects for our lead drug candidate Sulonex, 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: if, upon final analysis, it is determined that all trials of Sulonex should be terminated, our ability to successfully adjust our strategy and reduce our operating expenses in order to properly support the trials of our other drug candidates; if, upon final analysis of the Phase 3 data, it is determined that dosing should continue in the Phase 4 study, our ability to complete enrollment into the Phase 4 study on the timetable previously set for completion of Phase 4; our ability to complete cost- effective clinical trials or meet anticipated development timelines for the other drug candidates in our pi
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SOURCE Keryx Biopharmaceuticals, Inc.
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