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Zerenex(TM) (Ferric Citrate) Long-Term Phase 3 Study Results Published in the Journal of the American Society of Nephrology - Seite 4

About Zerenex(tm)

Zerenex(tm) (ferric citrate), is an oral, ferric iron-based phosphate binder.
Keryx has completed a U.S.-based phase 3 clinical program for Zerenex for the
treatment of hyperphosphatemia (elevated phosphate levels) in ESRD patients on
dialysis, conducted pursuant to a Special Protocol Assessment (SPA) agreement
with the FDA. To date, over 1,500 CKD patients have been exposed to Zerenex
through completed phase 2 and 3 clinical trials. 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 September 7, 2014. Keryx
has filed a Marketing Authorization Application (MAA) with the European
Medicines Agency (EMA), seeking the approval of Zerenex as a treatment of
hyperphosphatemia in patients with all stages of CKD and that application is
currently under review.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing
innovative therapies to market for patients suffering from renal disease. In
the United States, ferric citrate is currently under review by the Food and
Drug Administration (FDA) for the treatment of hyperphosphatemia in
dialysis-dependent chronic kidney disease (CKD) patients, where, pending
approval, it will be marketed as Zerenex(tm) by Keryx. In January 2014, ferric
citrate was approved for the treatment of patients with all stages of CKD in
Japan, where it is being marketed as Riona(r) by Keryx's Japanese partner, Japan
Tobacco Inc. and Torii Pharmaceutical Co. Ltd.

Cautionary Statement

Some of the statements included in this press release, particularly those
regarding the FDA's review, potential approval and subsequent commercialization
of 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 FDA, and/or
EMA could ultimately deny approval of the U.S. NDA, and/or MAA, respectively;
that the FDA and EMA may not 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; 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.


MEDIA CONTACTS:

Amy Sullivan
Vice President - Corporate Development and Public Affairs
Keryx Biopharmaceuticals, Inc.
Tel: [phone]
E-mail: [e-mail]
News Source: NASDAQ OMX


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Language: English
Company: Keryx Biopharmaceuticals, Inc.


United States
ISIN: US4925151015


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279327 24.07.2014