Keryx Biopharmaceuticals Announces Submission of a Marketing Authorization Application for Zerenex(TM) to the European Medicines Agency

Keryx Biopharmaceuticals Announces Submission of a Marketing Authorization Application for Zerenex(TM) to the European Medicines Agency

NEW YORK, March 10, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals,
Inc. (Nasdaq:KERX) (the "Company") today announced it has submitted a
Marketing Authorization Application ("MAA") to the European Medicines
Agency ("EMA"), seeking the approval of Zerenex(TM) (ferric citrate
coordination complex) as a treatment for hyperphosphatemia in patients
with chronic kidney disease ("CKD"), including dialysis- and
non-dialysis dependent CKD.

The MAA will be reviewed by the EMA Committee for Medicinal Products
for Human Use (CHMP) and the review will be conducted under the
Centralized Authorization Procedure. An approval under the Centralized
Authorization Procedure provides one marketing authorization which is
valid 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
pleased to have submitted our MAA, seeking European approval of Zerenex
for both dialysis and pre-dialysis and believe that this marks another
important milestone for Keryx. We thank the EMA for their guidance and
look forward to working with them over the course of the review
process."

The Company's new drug application for Zerenex is currently under
review by the FDA with an assigned Prescription Drug User Fee Act
(PDUFA) goal date of June 7, 2014. 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(R)) 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. The Company's Marketing
Authorization Application, seeking the approval of Zerenex as a
treatment of hyperphosphatemia in patients with CKD, including dialysis
and non-dialysis dependent CKD, has been submitted to the European
Medicines Agency (EMA). The Company is also developing Zerenex in the
U.S. for the management of elevated serum phosphorus and iron
deficiency anemia 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(R)) 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, 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 submission will not be accepted
for review by the EMA due to deficiencies in the application or for
other reasons; acceptance of the NDA filing for review by the FDA,
which occurred in October 2013, 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 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(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.


CONTACT: KERYX CONTACT:
        Lauren Fischer
        Director - Investor Relations
        Keryx Biopharmaceuticals, Inc.
        Tel: 212.531.5965
        E-mail: lfischer[email protected]
 

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