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Keryx Biopharmaceuticals Announces Completion of Patient Enrollment In Zerenex Phase 3 Short-Term Study
Date:10/26/2010

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Concurrent with this short-term study component of the Phase 3 registration program, the Company is conducting its long-term (58-week) Phase 3 safety and efficacy study component for which enrollment is ongoing. Keryx expects to complete the Zerenex Phase 3 program and file a New Drug Application for Zerenex for the treatment of hyperphosphatemia in the first half of 2012.

Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

PHASE 3 PROGRAM DESIGN:

In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex consists of two Phase 3 clinical studies, as follows:

Short-term efficacy study: A multicenter, randomized, open-label clinical trial with an enrollment of approximately 150 patients on hemodialysis, who are randomized to fixed doses of Zerenex, ranging from 1 gram per day to 8 grams per day, for a treatment period of 28 days. Patients undergo a 2-week washout period prior to randomization.  Patient enrollment for this study is now complete.  The primary endpoint of the study is to demonstrate a dose response in the change of serum phosphorous from baseline (end of washout period) to end of the treatment period (day 28).

Long-term safety and efficacy study: A multicenter, randomized, open-label, safety and efficacy clinical trial with a planned enrollment of approximately 300 patients on hemodialysis or peritoneal dialysis. The long-term study will consist of a 2-week washout period followed by a 52-week safety assessment in which patients will be randomized 2:1 to receive either Zerenex or another phosphate binder.  The 52-week safety assessment will be followed by a 4-week efficacy assessment in which only patients randomize
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SOURCE Keryx Biopharmaceuticals, Inc.
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