erenex and the active control group in serum calcium levels and liver enzymes, as measured by alanine transaminase (ALT) and aspartate transaminase (AST).
The full efficacy and safety data from the study is expected to be presented at a future medical conference.
Dr. Julia Lewis, Professor of Medicine, Department of Nephrology, Vanderbilt University School of Medicine, member of the Executive Committee of the Collaborative Study Group and Study Chair of the Zerenex Phase 3 registration program, commented, “We are very excited by the results announced today. The data from this study confirm that Zerenex is a safe and effective phosphate binder with the added benefit of improving patients’ iron levels while utilizing significantly less IV iron and ESAs. There is a clear need for viable alternatives to the marketed phosphate binders, and Zerenex can play a major role by not only providing adequate phosphate binding, but also providing additional benefits.”
Ron Bentsur, Chief Executive Officer of Keryx, stated, “We are thrilled by the robust outcome of this pivotal study for Zerenex, particularly with the magnitude of the drug’s effect on iron and anemia parameters, which should prominently differentiate Zerenex versus all the currently marketed phosphate binders. We believe that the ability to treat hyperphosphatemia, while also increasing iron storage parameters and reducing the need for IV iron and ESAs, sets a new paradigm for how a phosphate binder can be used to treat patients with end-stage renal disease on dialysis. We believe that these data position Zerenex to potentially become market leader in the phosphate binder market.” Mr. Bentsur continued, “We sincerely thank the study investigators and coordinators, and are particularly grateful to the Collaborative Study Group for their expertise, guidance and dedication to the clinical development of Zerenex.”
Zerenex is also in Phase 2 development in the U.S. for the management of phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferriccitrate) from Panion & BF Biotech, Inc. The Japanese rights are sublicensed by Keryx to Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii). On January 7, 2013, JT announced the filing of its NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). The NDA filing is supported by efficacy and safety data from several successfully completed Phase 3 studies in CKD patients with hyperphosphatemia in Japan.
Conference Call Information
Keryx will host a conference call today, January 28, 2013 at 8:00 a.m. Eastern Time to present the top-line results from this long-term Phase 3 study for Zerenex. The conference call can be accessed by dialing 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The rebroadcast of the conference call will be available for replay at http://www.keryx.com, for a period of 15 days after the call.
About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official eva luation and written guidance on the design and size of proposed protocols t
