Keryx Biopharmaceuticals Initiates Phase 2 Study of Zerenex™ (ferric citrate) for the Treatment of Patients with Non-Dialysis

Keryx Biopharmaceuticals Initiates Phase 2 Study of Zerenex™ (ferric citrate)
   for the Treatment of Patients with Non-Dialysis Dependent Chronic Kidney
                                   Disease

  PR Newswire

  NEW YORK, Nov. 1, 2012

NEW YORK, Nov. 1, 2012 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq:
KERX) announced today the initiation of a Phase 2 study of Zerenex™ (ferric
citrate), the Company's ferric iron-based phosphate binder drug candidate, in
managing serum phosphorus and iron deficiency in anemic patients with Stage 3
to 5 non-dialysis dependent chronic kidney disease ("NDD-CKD"). In the United
States alone, over one and a half million people suffering from Stages 3 to 5
NDD-CKD have iron deficiency anemia, however, there are currently no oral iron
supplements with an FDA label in NDD-CKD. Also, there are currently no FDA
approved phosphate binders in NDD-CKD.

The Phase 2 study initiated today is a multicenter, randomized, safety and
efficacy clinical trial designed to compare the ability of Zerenex to manage
serum phosphorus and iron deficiency versus placebo in anemic patients with
Stages 3 to 5 NDD-CKD. Eligible patients will be randomized 1:1 to receive
either Zerenex or placebo for a 12-week treatment period. The primary
endpoints of the study are to demonstrate changes in ferritin, TSAT and serum
phosphorus levels over the 12-week treatment period. Secondary endpoints
include changes in hemoglobin and FGF-23. The study plans to randomize
approximately 150 patients from approximately 15 sites in the U.S. Patient
enrollment is expected to take up to 6 months, with study completion expected
in mid-2013.

The study's three Co-Chairmen are:

  *Geoffrey A. Block, MD, Director of Clinical Research at Denver Nephrology
    and Associate Clinical Professor in Medicine at the University of Colorado
    Health Sciences Center;
  *Glenn Chertow, MD, Chief, Division of Nephrology and Professor of Medicine
    at Stanford University School of Medicine; and
  *Steven Fishbane, MD, Vice President of North Shore-LIJ Health System for
    Network Dialysis Services and Director of Clinical Research at North
    Shore-LIJ Department of Medicine.

Dr. Block commented, "I am pleased to be leading this study for Zerenex.
Several studies, including the REIN and ARIC studies, have demonstrated that
elevated serum phosphorus is a predictor of morbidity and mortality in
NDD-CKD. Therefore, I believe that additional clinical trials aimed at
controlling serum phosphorus in NDD-CKD are important. I further believe that
with Zerenex's potential to also address iron deficiency, it could become an
important agent in the NDD-CKD setting."

Dr. Fishbane commented, "I am particularly intrigued by Zerenex's potential
utility in NDD-CKD. Despite the high prevalence of iron deficiency anemia in
NDD-CKD patients, the oral iron supplements that are currently available have
inadequate efficacy and tolerability issues. Moreover, due to logistical
constraints in NDD-CKD, intravenous iron and ESAs are not readily accessible
to most patients. Consequently, I believe that iron deficiency anemia in
NDD-CKD represents a substantial underserved medical need."

Ron Bentsur, Chief Executive Officer of Keryx, commented, "We are very excited
about the initiation of this Zerenex Phase 2 study in the additional
indication of NDD-CKD, which could represent a largely untapped market
opportunity for Zerenex." Mr. Bentsur added, "With an expected discretionary
spend of approximately $3 million for the study, we believe that this program
is a compelling value-creation opportunity for Keryx."

Zerenex is currently also in a long-term Phase 3 study, under Special Protocol
Assessment, as treatment for end-stage renal disease patients with
hyperphosphatemia on dialysis. Top-line data from this Phase 3 study is
expected to be announced by approximately year-end 2012, with the NDA filing
expected in the first quarter of 2013 for this indication.

Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the
Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech,
Inc. The Company has sublicensed the development of ferric citrate in Japan to
Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

About Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anemia

It is estimated that approximately 10 to 15% of the U.S. adult population is
affected by chronic kidney disease (CKD), a condition generally characterized
by greater than 50% reduction of normal kidney function. In addition,
elevated levels of serum phosphorus become more prevalent in Stages 3 to 5
non-dialysis dependent CKD (NDD-CKD) patients. Several studies have shown
that higher serum phosphorus concentrations may be associated with increased
mortality and morbidity in CKD, however, no phosphate binders are currently
FDA approved for NDD-CKD.

Iron deficiency anemia, which develops early in the course of CKD and worsens
with disease progression, is extremely prevalent in the NDD-CKD population and
is associated with fatigue, lethargy, decreased quality of life and is also
believed to be associated with cardiovascular complications, hospitalizations,
and increased mortality. Based on data contained in a 2009 publication in the
Journal of the American Society of Nephrology, it is estimated that over 1.5
million adults with NDD-CKD in the U.S. alone are also afflicted with iron
deficiency anemia. To combat this anemia, iron replacement therapy is
essential to increase iron stores, such as ferritin and TSAT levels, and raise
hemoglobin levels. Currently available oral iron supplements are associated
with limited efficacy and dose-limiting tolerability issues. No oral iron
agents are currently FDA approved to treat iron deficiency anemia in NDD-CKD.
Erythropoiesis stimulating agents (ESAs) and intravenous (IV) iron are not
frequently administered in NDD-CKD due to both the FDA warning label of
potential cardiovascular risk for ESAs in NDD-CKD and logistical complications
associated with administering IV medicines in office settings which lack the
necessary facilities, such as emergency equipment and/or emergency medical
access. Consequently, the NDD-CKD patient population remains underserved.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticalsis focused on the acquisition, development and
commercialization of medically important pharmaceutical products for the
treatment of renal disease. Keryx is developing Zerenex (ferric citrate), an
oral, ferric iron-based compound that has the capacity to bind to phosphate
and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for
the treatment of hyperphosphatemia (elevated phosphate levels) in patients
with end-stage renal disease is being conducted pursuant to a Special Protocol
Assessment (SPA) agreement with the FDA. Zerenex is also in Phase 2
development for the management of phosphorus and iron deficiency in anemic
patients with Stage 3 to 5 non-dialysis dependent chronic kidney disease.
Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those
anticipating future clinical trials and business prospects for Zerenex (ferric
citrate) 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: our ability, and our Japanese
partner's ability, to successfully and cost-effectively complete clinical
trials for Zerenex (ferric citrate); the risk that the data (both safety and
efficacy) from the ongoing Phase 3 trials for Zerenex (ferric citrate) will
not coincide with the data analyses from previous clinical trials reported by
the Company; the risk that the data (both safety and efficacy) from the
ongoing Phase 2 study in non-dialysis dependent chronic kidney disease will be
negative or inconclusive; our ability to meet anticipated development
timelines for Zerenex due to clinical trial results, manufacturing
capabilities or other factors; and other risk factors identified from time to
time in our reports filed with theSecurities 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.

KERYX CONTACT:Lauren FischerDirector – Investor RelationsKeryx
Biopharmaceuticals, Inc.Tel: +1-212-531-5965E-mail: lfischer@keryx.com

Website: http://www.keryx.com
 
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