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

Keryx Biopharmaceuticals, Inc. 17.10.2013 14:30 --------------------------------------------------------------------------- NEW YORK, 2013-10-17 14:30 CEST (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that abstracts highlighting Zerenex(tm) (ferric citrate coordination complex), the Company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis, have been selected for oral and poster presentations during the American Society of Nephrology (ASN) Kidney Week 2013 annual meeting. This annual meeting of the ASN will be held in Atlanta, Georgia, from November 5-10, 2013. Summary of Zerenex(tm) (ferric citrate coordination complex) Data Presentations: ORAL PRESENTATION: Saturday, November 9th: Abstract#: SA-OR083 - Title: Ferric Citrate, a Phosphate Binder, Increases Iron Stores but Is Not Associated with Evidence of the Malnutrition-Inflammation-Cachexia Syndrome - Session Name: Dialysis: Anemia, Inflammation, Malnutrition, and Metabolism - Presentation Time: 5:30pm CLINICAL POSTER PRESENTATIONS: Thursday, November 7th: Abstract #: TH-PO521 - Title: Ferric Citrate as a Phosphate Binder Reduces IV Iron and Erythropoietin Stimulating Agent (ESA) Use - Session Name: Dialysis: Anemia, Inflammation, Malnutrition, & Metabolism - I - Presentation Time: 10:00am Saturday, November 9th: Abstract #: SA-PO382 - Title: Achieved Iron Stores and Clinical Outcomes in a Trial of Ferric Citrate as a Phosphate Binder - Session Name: Dialysis: Anemia, Inflammation, Malnutrition, & Metabolism - II - Presentation Time: 10:00am Abstract #: SA-PO540 - Title: Ferric Citrate as a Phosphate Binder Has a Safety Profile Similar to Sevelamer Carbonate and Calcium Acetate - Session Name: Mineral Disease: CKD-MBD - II - Presentation Time: 10:00am Abstract #: SA-PO542 - Title: Ferric Citrate Binds Phosphorus, Delivers Iron, and Reduces IV Iron and Erythropoietic Stimulating Agent Use in End-Stage Renal Disease - Session Name: Mineral Disease: CKD-MBD - II - Presentation Time: 10:00am Abstract #: SA-PO543 - Title: Impact of Ferric Citrate, an Oral Phosphate Binder, on Mineral and Bone Metabolism Markers in Dialysis - Session Name: Mineral Disease: CKD-MBD - II - Presentation Time: 10:00am In addition, one abstract from the Company's Japanese partner for Zerenex, Japan Tobacco, Inc., relating to its Phase 3, multicenter, randomized, double-blind, placebo-controlled study in non-dialysis dependent Japanese patients with CKD, has also been accepted for poster presentation during the annual meeting: Abstract #: SA-PO544 - Title: The Effect of JTT-751 (Ferric Citrate Hydrate) on Phosphorus and FGF-23 in Chronic Kidney Disease - Session Name: Mineral Disease: CKD-MBD - II - Presentation Date/Time: Saturday, November 9th, 10:00am The above abstracts are currently available online for viewing through the ASN website at: http://www.asn-online.org/education/kidneyweek/archives/. Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex (ferric citrate coordination complex) 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 coordination complex), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. 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 on dialysis, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA), and the Company's New Drug Application is currently under review by the FDA. The Marketing Authorization Application filing with the European Medicines Agency (EMA) is pending submission. Zerenex is also in Phase 2 development in the U.S. for the management of elevated phosphorus and iron deficiency in anemic patients with Stages 3 to 5 non-dialysis dependent chronic kidney disease. In addition, Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has filed its New Drug Application for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease. 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 the timing of any such review, 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: acceptance of the NDA filing does not represent final evaluation of the adequacy of the data submitted in the NDA; whether the FDA will complete its review of the NDA on a timely basis; the risk that the FDA, EMA, and Japanese Ministry of Health, Labour and Welfare ultimately deny approval of the U.S. NDA, MAA and Japanese NDA, 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, Zerenex, if approved, 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 www.keryx.com.The information on our website, and on the ASN website, is not incorporated by reference into this press release and is included as an inactive textual reference only. KERYX CONTACT: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: lfischer@keryx.com News Source: NASDAQ OMX 17.10.2013 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 Phone: Fax: E-mail: Internet: ISIN: US4925151015 WKN: End of Announcement DGAP News-Service ---------------------------------------------------------------------------