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Keryx Biopharmaceuticals Announces PDUFA Goal Date for Zerenex(TM) New Drug Application



Keryx Biopharmaceuticals Announces PDUFA Goal Date for Zerenex(TM) New Drug
Application

NEW YORK, Oct. 21, 2013 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc.
(Nasdaq:KERX) announced today that the U.S. Food and Drug Administration (FDA)
assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014,
for the Company's New Drug Application (NDA) for 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.

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
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, EMA,
and/or the Japanese Ministry of Health, Labour and Welfare ultimately deny
approval of the U.S. NDA, MAA and/or 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
http://www.keryx.com. The information found on our website, and the FDA
website, is not incorporated by reference into this press release and is
included for reference purposes only.

CONTACT: Lauren Fischer
         Director - Investor Relations
         Keryx Biopharmaceuticals, Inc.
         Tel: 212.531.5965
         E-mail: lfischer@keryx.com

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