DGAP-News: Keryx Biopharmaceuticals' Zerenex(TM) Data

DGAP-News: Keryx Biopharmaceuticals, Inc. / Keryx Biopharmaceuticals' Zerenex(TM) Data Selected for Poster Presentation at the AMCP's 26th Annual Meeting and Expo 17.03.2014 / 13:30 --------------------------------------------------------------------- Poster Highlights Potential Pharmacoeconomic Benefit for Managed Care Organizations NEW YORK, 2014-03-17 13:30 CET (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that data highlighting the potential pharmacoeconomic benefit of Zerenex(tm) (ferric citrate coordination complex), the Company's drug candidate for the treatment of hyperphosphatemia in dialysis patients, has been selected for poster presentation during the upcoming Academy of Managed Care Pharmacy's (AMCP) 26th Annual Meeting and Expo, being held April 1-4, 2014, at the Tampa Convention Center in Tampa, Florida. The poster, entitled, 'Phosphorus Binding with Ferric Citrate Reduces Managed Care Costs Through Reduced Use of IV Iron and Erythropoiesis-Stimulating Agents (ESAs),' is scheduled to be presented in the poster session on Thursday, April 3, 2014, from 11:30am-2:30 pm, in the West and Central Hall of the convention center. The abstract (Abstract No. N1EM) can be viewed online at the AMCP website: http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=17843. About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex(tm) (ferric citrate coordination complex), an oral, ferric iron-based compound. Zerenex has completed a U.S.-based Phase 3 clinical program for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease on dialysis, conducted pursuant to a Special Protocol Assessment agreement with the FDA. Keryx's New Drug Application, submitted to the FDA in 2013, is currently under review and has an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. Keryx has recently submitted a Marketing Authorization Application filing to the European Medicines Agency. Zerenex has also completed a Phase 2 study in the U.S. for the management of elevated serum phosphorus levels and iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease. In addition, Keryx's Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd., received marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease on January 17, 2014. 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 and pharmacoeconomical benefits to be derived from Zerenex, 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 MAA will not be accepted for review by the EMA due to deficiencies in the application or for other reasons; acceptance of the NDA filing represents only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during the FDA's review; a PDUFA goal date 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 drug 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(r) 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; if approved, whether any meaningful pharmacoeconomic benefits will be generated with the use of Zerenex; 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 on the website of the Academy of Managed Care Pharmacy at http://www.amcp.org, is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: KERYX CONTACT:Lauren FischerDirector - Investor RelationsKeryx Biopharmaceuticals, Inc.Tel: 212.531.5965E-mail: lfischer@keryx.com News Source: NASDAQ OMX End of Corporate News --------------------------------------------------------------------- 17.03.2014 Dissemination of a Corporate News, transmitted by DGAP - a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de --------------------------------------------------------------------- Language: English Company: Keryx Biopharmaceuticals, Inc. United States ISIN: US4925151015 End of News DGAP News-Service --------------------------------------------------------------------- 257819 17.03.2014