Keryx Biopharmaceuticals, Inc. announced that it has received positive scientific advice from the European Medicines Agency (EMA) for the development of Zerenex (ferric citrate) for the management and control of serum phosphorus in End-Stage Renal Disease (ESRD) patients undergoing dialysis, and in pre-dialysis Chronic Kidney Disease patients (CKD).

The Scientific Advice from the EMA indicates that the company's current phase III programme in the United States, if successful, in conjunction with safety data generated from other clinical studies with Zerenex, is considered sufficient to support a European Marketing Authorization Application (MAA) to the EMA for the indication in ESRD patients on dialysis. Therefore, the company believes that it will not need to conduct any additional clinical trials with Zerenex in order to obtain European approval in the dialysis setting.

The Scientific Advice has also provided the Company with a regulatory path forward in the pre-dialysis CKD setting in Europe.

Ron Bentsur, CEO of Keryx, stated, “The EMA's Scientific Advice for Zerenex represents a significant step toward the registration of Zerenex in Europe, which we believe would put European approval on a similar timetable as US approval.” Bentsur continued, “In addition to the dialysis setting, with a clear regulatory path forward in the pre-dialysis CKD setting, we believe we now have an opportunity to fully capitalize on the significant global market for phosphate binders.” Bentsur added, “We wish to thank the EMA's Scientific Advice Working Party for their input and guidance.”

Zerenex (ferric citrate), a ferric iron-based phosphate binder, is currently in phase III clinical development in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis which is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by the Company to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

Scientific Advice is a procedure offered by the EMA to stakeholders for clarification of questions arising during development of medicinal products. The scope of Scientific Advice is limited to scientific issues, i.e. to quality, non-clinical and clinical aspects of the concerned medicinal product not yet unequivocally covered by published scientific guidelines. It focuses on development strategies rather than pre-evaluation of data to support an MAA. The advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease.