Zerenex (Keryc Biophrama) succuss in Phase III trial for Hyperphosphatemia

Keryx Biopharmaceuticals, Inc.announced successful top-line results from the long-term Phase III study of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or Hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents versus the active control over the 52-week Safety Assessment Period of the study.

This long-term study was the final component of the Company's Phase III registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) with the FDA. In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase III registration program.

Keryx expects to submit a New Drug Application with the FDA and a Marketing Authorization Application with the European Medicines Agency for Zerenex in the second quarter of 2013.