NEW YORK, May 21, 2012 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that an abstract highlighting the dose related increases in iron storage parameters as observed in prior clinical trials of Zerenex (ferric citrate), has been accepted for poster presentation at the upcoming 49th ERA-EDTA (European Renal Association European Dialysis and Transplant Association) Congress, taking place May 24-27, 2012, in Paris, France.
The following poster will be presented on Saturday, May 26, 2012, from 9:30am to 10:45am local time:
- A Meta-Analysis of Ferric Citrate for Hyperphosphatemia: The Effects of an Oral Iron-Containing Phosphate Binder on Serum Ferritin and Saturated Transferrin in Hemodialysis Patients (Abstract # SAP534)
Zerenex, the Company’s oral, ferric iron-based drug candidate for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis, is currently in Phase 3 clinical development pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. The Zerenex Phase 3 registration program is comprised of an already completed Phase 3 short-term study, and an ongoing Phase 3 long-term study.
The above referenced abstract is available for viewing on-line at http://www.m-events.com/customer/2012/era-edta/data/12575.pdf.
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 Keryx to Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex (ferric citrate) 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: our ability, and our Japanese partner’s ability, to successfully and cost-effectively complete clinical trials for Zerenex (ferric citrate); the risk that the data (both safety and efficacy) from the ongoing Phase 3 trials for Zerenex (ferric citrate) will not coincide with the data analyses from previous clinical trials reported by us and our Japanese partner; our ability to meet anticipated development timelines for Zerenex due to clinical trial results, manufacturing capabilities or other factors; our ability to replicate in our ongoing long-term Phase 3 clinical study the effects on iron storage parameters, intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) use observed in previous clinical trials; the ability for Zerenex to generate cost savings for dialysis centers and payers; 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, and the M Events website, is not incorporated by reference into this press release and are included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
