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Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
Date:2/11/2008

NEW YORK, Feb. 11 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals announced today that the last subject randomized into the SUN-Micro Phase 3 clinical trial has completed their scheduled 8 month visit. This milestone officially marks the completion of this pivotal clinical trial of its investigational drug Sulonex(TM) (sulodexide oral gelcap) in the treatment of subjects with type 2 diabetes and persistent microalbuminuria despite treatment with the maximum approved or tolerated dose of either an Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). This randomized, double-blind, placebo-controlled study enrolled 1,056 subjects at over 150 sites worldwide.

The Company anticipates being able to report top-line results from this study before the end of March 2008, and expects that the Collaborative Study Group will make a comprehensive scientific presentation of the data at a medical conference in the 2nd or 3rd quarter. The Company is targeting an NDA filing before year end.

"The completion of the Sulonex Phase 3 clinical program is an important and significant milestone for Keryx," stated Michael S. Weiss, Chairman and CEO of the Company, who continued, "We recognize and are grateful for the dedication, diligence and compliance exhibited by the Collaborative Study Group and the more than 1,000 patients who participated in what is considered to be the largest ever randomized study for type 2 diabetic patients with persistent microalbuminuria."

Commenting on the news, Edmund J. Lewis, MD, co-Principal Investigator of the Phase 3 Study remarked, "We would like to commend both our Investigators and their patients for their level of commitment towards the completion of this pivotal 8-month study, marking the culmination of critical research in a disease area for which there has not been a novel treatment option in almost 15 years. We look forward to assembling and analyzing the data from this study."

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