NEW YORK, April 9, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today announced that Phase 2 clinical results of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease (NDD-CKD) patients with elevated serum phosphorus and iron deficiency anemia has been selected as a Late Breaking oral presentation at the National Kidney Foundation 2014 Spring Clinical Meeting, taking place April 22-26, 2014 in Las Vegas, NV. This presentation, entitled "Zerenex™ (Ferric Citrate) for the Treatment of Iron-Deficiency Anemia and Reduction of Serum Phosphate in Non-Dialysis Dependent CKD," will be made during the Late Breaking Session on Friday, April 25, 2014, from 9:30am - 11:00am PDT, by Dr. Geoffrey Block, Director of Clinical Research at Denver Nephrology and Co-Chairman for this study.
In addition to the late-breaking oral presentation, the following four abstracts have also been selected for poster presentation during the meeting.
- "Phosphorus Binding with Ferric Citrate is Associated with Fewer Hospitalizations and Reduced Hospitalization Costs," R. Rodby, poster number 422;
- "Economic Impact of Ferric Citrate Versus Standard of Care for Hemodialysis Patients," S. Brunelli, poster number 156;
- "Phosphorus Binding with Ferric Citrate Reduces Erythropoiesis-Stimulating Agent (ESA) and IV Iron Usage and Cost in Patients with ESRD," R. Rodby, poster number 415; and
- "Oral Ferric Citrate Eliminates the Need for Intravenous (IV) Iron in Dialysis Patients," M. Sika, poster number 79.
Posters will be presented in the Exhibit Hall on Wednesday, April 23, from 6:00pm-7:30pm PDT.
Each of the above mentioned abstracts are currently available on the National Kidney Foundation's website: http://www.kidney.org/news/meetings/clinical/abstract/index.cfm.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate coordination complex), an oral, ferric iron-based compound. Keryx has completed a U.S.-based Phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease (CKD) on dialysis, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA). The Company's New Drug Application (NDA) is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014, and its Marketing Authorization Application, seeking the approval of Zerenex as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, is currently under review by the European Medicines Agency (EMA). The Company is also developing Zerenex in the U.S. for the management of iron deficiency anemia and elevated serum phosphorus in patients with Stage 3 to 5 non-dialysis dependent CKD. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those relating to the results of clinical trials, the clinical benefits to be derived from Zerenex (ferric citrate coordination complex), regulatory submissions and approvals, the commercial opportunity and competitive positioning, and any business prospects for Zerenex, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the risk that the FDA PDUFA goal date for our Zerenex NDA is subject to change and does not guarantee that the review of the NDA will be completed on a timely basis; the risk that the FDA, and/or EMA ultimately deny approval of the U.S. NDA, and/or MAA, respectively; the risk that SPAs are not a guarantee that the FDA will ultimately approve a product candidate following filing acceptance; whether the FDA and EMA will concur with our interpretation of our Phase 3 study results, supportive data, or the conduct of the studies; whether Riona® will be successfully launched and marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd.; whether, Zerenex, if approved by the FDA and/or EMA, will be successfully launched and marketed; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website, or on the website of the National Kidney Foundation at http://www.kidney.org, is not incorporated by reference into this press release and is included for reference purposes only.