FDA approves Ferric Citrate for control of serum phosphorus levels in CKD patients on dialysis

Ferric citrate: highly effective at controlling serum phosphorus levels, with unique pharmacodynamic properties

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today announced that the U.S. Food and Drug Administration (FDA) approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

"We are thrilled with the FDA's decision to approve Ferric Citrate, and look forward to bringing it to market in the U.S. within the next 12 weeks," said Ron Bentsur, Chief Executive Officer of Keryx. "We are committed to bringing innovative therapies to the market for patients with kidney disease and are excited to be offering this important treatment option to dialysis patients."

The U.S. approval of Ferric Citrate was based on data from its Phase 3 registration program. In the Phase 3 clinical trials, Ferric Citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. In addition to the effects on serum phosphorus levels, Ferric Citrate's pharmacodynamic properties resulted in increased ferritin and transferrin saturation (TSAT); whereas these parameters remained relatively constant in patients treated with active control (Renvela- and/or Phoslo-). The most common adverse events for Ferric Citrate treated patients were gastrointestinal-related, including diarrhea, nausea, vomiting and constipation.

"I believe that Ferric Citrate offers clear benefits to patients and represents a new way for physicians to manage hyperphosphatemia," said Julia Lewis, MD, lead investigator, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "Given Ferric Citrate's pharmacodynamic properties that lead to increases in iron stores, physicians should assess and monitor iron parameters and may need to reduce the dose of or discontinue IV iron therapy."

Recently, the Company was informed by the FDA that approval of the brand name Zerenex had been rescinded. Keryx believes the Company will have an approved brand name on or prior to launch, although a brand name is not a pre-requisite for the launch of an FDA-approved drug.