NEW YORK, May 2, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. , announced today that it has received positive Scientific Advice from the European Medicines Agency (EMA) for the development of Zerenex(TM) (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 3 program 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, Chief Executive Officer 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 U.S. approval." Mr. 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." Mr. 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 3 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.