Keryx Biopharmaceuticals supplies AURYXIA tablets to wholesalers in US

Dec 22 2014

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today announced it has begun shipping AURYXIA™ (ferric citrate) tablets to wholesalers in the U.S. Auryxia is approved for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. Auryxia is the first and only absorbable-iron-based phosphate binder that is clinically proven to effectively control phosphate levels within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. The U.S. Food and Drug Administration (FDA) approved Auryxia in September 2014. For more information visit http://www.auryxia.com/.

"We are extremely proud to bring Auryxia to market in the U.S. Auryxia is a new treatment option for nephrologists that fits squarely into their current treatment protocols," said Ron Bentsur, Chief Executive Officer of Keryx. "We have built a world-class renal commercial team at Keryx and are eager to deliver the first and only absorbable-iron-based phosphate binder to dialysis patients."

"Dialysis patients and their healthcare providers will benefit from having an additional phosphate binder available," commented Julia Lewis, MD, nephrologist and Professor of Medicine at Vanderbilt University Medical Center. "Auryxia's clinical profile is compelling and I believe will be of value for my patients."

End-stage renal disease (ESRD) represents the most severe stage of CKD, as many metabolic factors, such as iron and phosphorus, are out of balance. The majority of ESRD patients require chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. In addition, iron can be severely depleted in dialysis patients and they therefore are often treated with intravenous iron and other medications. Approximately 450,000 ESRD patients require dialysis in the U.S., with the number projected to rise in the future.

Dr. Geoffrey Block, Director of Clinical Research at Denver Nephrology commented, "I am very pleased to be able to offer my dialysis patients an effective new treatment option. Unlike other phosphate binders, Auryxia is the only absorbable-iron-based phosphate binder."

Commitment to Dialysis Patients

The Company has created the "Keryx Patient Plus" program to assist with patient accessibility to Auryxia. Beginning at the Company's reimbursement hub, personalized service is provided through dedicated regional case managers to provide the renal care team with comprehensive insurance and reimbursement support for their patients. Keryx Patient Plus offers benefit verification, co-pay assistance for eligible commercial patients, free-drug program for those who qualify, and a short-term prescription bridge program that may assist those already on Auryxia who are in danger of suffering a break in coverage.

"Through the work of our field force and the commercialization activities executed to date, awareness and anticipated demand for Auryxia has continued to grow among our target audiences," said Greg Madison, Chief Operating Officer of Keryx. "We intend to build off that momentum to position Auryxia as we develop the potential of this important product in the market."

​SOURCE Keryx Biopharmaceuticals, Inc.