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Keryx Biopharmaceuticals Announces Completion of Patient Enrollment in Zerenex™ (Ferric Citrate) Phase 3 Long-Term Study
Date:9/19/2011

-term study, over-enrolling slightly to meet patient and physician interest in the study.  We remain grateful to the investigators for their continued dedication and commitment to the clinical development of Zerenex."

In April 2011, the Company reported the positive final dataset from the Zerenex Phase 3 short-term study.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc.  The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

About Special Protocol Assessments

The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application.

Final marketing approval depends on the efficacy and safety results, including the adverse event profile, and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. For more information on Special Protocol Assessment, please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf.

About Hyperphosphatemia

In the United States, according to data from the U.S. Renal Data System, there are approximately 548,000 patients with end-stage renal disease, or ESRD, and the number of ESRD patients is projected to rise over 40% to approximately 785,000 by 2020. The majority of ESRD patients, over 375,000, require dialysis. Phosphate retention and the resulting hyperphosphatemia in patie
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SOURCE Keryx Biopharmaceuticals, Inc.
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