Dr. Fishbane commented, "I am particularly intrigued by Zerenex's potential utility in NDD-CKD. Despite the high prevalence of iron deficiency anemia in NDD-CKD patients, the oral iron supplements that are currently available have inadequate efficacy and tolerability issues. Moreover, due to logistical constraints in NDD-CKD, intravenous iron and ESAs are not readily accessible to most patients. Consequently, I believe that iron deficiency anemia in NDD-CKD represents a substantial underserved medical need."
Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very excited about the initiation of this Zerenex Phase 2 study in the additional indication of NDD-CKD, which could represent a largely untapped market opportunity for Zerenex." Mr. Bentsur added, "With an expected discretionary spend of approximately $3 million for the study, we believe that this program is a compelling value-creation opportunity for Keryx."
Zerenex is currently also in a long-term Phase 3 study, under Special Protocol Assessment, as treatment for end-stage renal disease patients with hyperphosphatemia on dialysis. Top-line data from this Phase 3 study is expected to be announced by approximately year-end 2012, with the NDA filing expected in the first quarter of 2013 for this indication.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.About Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anemia It is estimated that approximately 10 to 15% of the U.S. adult population is affected by chronic kidney disease (CKD), a condition generally characterized by greater than 50% reduction of normal kidney function. In addition, elevated levels of serum phosphorus become more prevalent in Stages 3 to 5 non-dialysis dependent CKD (NDD-CKD) patients. Several studies have shown that higher serum phosphorus concentrations may be associated with increased mortality and morbidity in CKD, however, no phosphate binders are currently FDA approved for NDD-CKD.