Keryx Biopharmaceuticals Announces EMA Validation of Marketing Authorization Application for Zerenex(TM)

NEW YORK, April 2, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. KERX (the "Company") today announced that the European Medicines Agency ("EMA") has determined that the Company's Marketing Authorization Application ("MAA") seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease ("CKD"), including dialysis- and non-dialysis-dependent CKD, is valid. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

The EMA's review of the application will follow the centralized marketing authorization procedure. If approved by the EMA, Zerenex™ will receive marketing authorization in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.

Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are grateful for the EMA's quick validation of our MAA submission and look forward to working with the EMA during the MAA review process."

The Company also has a New Drug Application for Zerenex under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014 seeking the approval of Zerenex for the treatment of hyperphosphatemia in patients with CKD on dialysis. In January, it was announced that the Company's Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd. ("JT/Torii"), 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 Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to JT/Torii.

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 validation of the Zerenex MAA by the EMA, which is being reported today, represents only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during the EMA review process; 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 is not incorporated by reference into this press release and is included for reference purposes only.