DGAP-News

Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology

DGAP-News: Keryx Biopharmaceuticals, Inc. /
Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published
in the Journal of the American Society of Nephrology

24.07.2014 / 22:59

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Data Demonstrate the Drug Candidate's Potential to Become the First Phosphate
Binder to Increase Iron Stores While Reducing the Need for IV Iron and
Erythropoiesis-Stimulating Agents in End-Stage Renal Disease Patients on
Dialysis

NEW YORK, 2014-07-24 23:00 CEST (GLOBE NEWSWIRE) --
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the 'Company') announced the
publication of results from the long-term, randomized, active control Phase 3
study of Zerenex (ferric citrate), the Company's investigational oral ferric
iron-based phosphate binder, for the treatment of hyperphosphatemia in patients
with end-stage renal disease (ESRD) on dialysis. The PERFECTED study (PhosphatE
binding and iRon delivery with FErric CiTrate in EsrD) was published online
today in the Journal of the American Society of Nephrology (JASN).

This Phase 3 study was a multicenter, randomized, open-label trial in 441 ESRD
patients on hemodialysis or peritoneal dialysis designed to determine the
safety and efficacy of Zerenex as a treatment to reduce serum phosphorus as
well as raise iron stores and reduce intravenous (IV) iron and
erythropoietin-stimulating agents (ESA) usage.

Zerenex met the study's primary end-point demonstrating a highly statistically
significant change in serum phosphorus versus placebo over the four-week
Placebo Control Period. Using a sequential gatekeeping strategy for the key
pre-defined secondary end-points, Zerenex also demonstrated statistically
significant increases in serum ferritin and transferrin saturation (TSAT), and
significant reductions in the use of IV iron and ESAs, versus an active control
of Renvela(r) (sevelamer carbonate) and/or Phoslo(r) (calcium acetate) over the
52-week Active Control Period of the study. In addition, mean hemoglobin levels
were higher in subjects treated with Zerenex as compared to subjects treated
with active control.

'Zerenex effectively reduces serum phosphorus levels within the KDOQI range
(3.5 mg/dL to 5.5 mg/dL) while having the additional patient benefits of
increasing iron stores and decreasing the need for IV iron and ESAs, while
maintaining hemoglobin levels,' said Julia Lewis, MD, lead investigator,
nephrologist and Professor of Medicine at Vanderbilt University Medical Center.
'If approved, the combined benefits of Zerenex would be of value for patients,