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Keryx Biopharmaceuticals, Inc. Announces Zerenex™ Phase 3 Data Presented at the 2013 World Congress of Nephrology

 Keryx Biopharmaceuticals, Inc. Announces Zerenex™ Phase 3 Data Presented at
                    the 2013 World Congress of Nephrology

  PR Newswire

  NEW YORK, June 3, 2013

NEW YORK, June 3, 2013 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq:
KERX) today announced the presentation of updated efficacy and safety data
from the Phase 3 long-term clinical trial of Zerenex (ferric citrate), the
Company's ferric iron-based phosphate binder drug candidate for the treatment
of elevated serum phosphorus levels, or hyperphosphatemia, in patients with
end-stage renal disease (ESRD) on dialysis. Dr. Julia Lewis, Professor of
Medicine, Department of Nephrology, Vanderbilt University School of Medicine,
and member of the Executive Committee of the Collaborative Study Group, and
Study Chair of the Zerenex Phase 3 registration program, presented the updated
dataset from the study entitled "A 58-Week Safety and Efficacy Trial of Ferric
Citrate in Patients With ESRD on Dialysis," in a symposium held earlier today
in Hong Kong, during the 2013 World Congress of Nephrology (WCN) and a poster
presented yesterday, Sunday, June 2, 2013.

Study Design

This Phase 3 long-term study was a multicenter, randomized, open-label, safety
and efficacy clinical trial in 441 ESRD patients on hemodialysis or peritoneal
dialysis. The study consisted of a 2-week washout period followed by a 52-week
Safety Assessment Period (SAP) in which subjects were randomized 2:1 to
receive either Zerenex or an active control (Renvela® [sevelamer carbonate]
and/or Phoslo® [calcium acetate]). The 52-week SAP was followed by a 4-week
Efficacy Assessment Period (EAP). During the EAP, only those subjects
randomized to treatment with Zerenex during the SAP, and completed the 52-week
SAP, were randomized in a 1:1 ratio to either continue treatment with Zerenex
or switch to placebo for a 4-week treatment period. Subjects were titrated
during the study to achieve normal serum phosphorus levels of 3.5 to 5.5
mg/dL. Zerenex was administered using a 1 gram oral caplet formulation.

Oral iron therapy was not permitted during the course of the study.
Intravenous (IV) iron therapy was not permitted if a subject's serum ferritin
level was greater than 1,000 ng/mL or transferrin saturation (TSAT) was
greater than 30%. The use of erythropoiesis-stimulating agents (ESAs) was at
the physician's discretion.

Study Efficacy Results

Dr. Lewis' presentation confirmed that Zerenex met the pre-defined primary and
key secondary endpoints, highlighting that Zerenex is an efficacious and safe
oral phosphate binder that controls serum phosphorus, increases iron stores as
measured by serum ferritin and TSAT, and reduces the use of IV iron and ESAs,
while sustaining hemoglobin as compared to the active control group.

The following results from the study were presented in the oral presentation
given by Dr. Lewis on Monday, June 3, 2013 (Hong Kong time) at the WCN.

Table 1 - Primary Endpoint: Zerenex effectively controls serum phosphorus in
the EAP.

Serum Phosphorus (mg/dL)             Zerenex N=92 Placebo N=91
Week 52 Baseline, Mean (SD)          5.1 (1.2)    5.4 (1.5)
Week 56(1), Mean (SD)                4.9 (1.3)    7.2 (1.8)
Change from Baseline                 -0.2         +1.8
LS Mean (SE) Treatment Difference(2) -2.27 (0.21)

Treatment Difference P-Value(2)      p<0.0001

(1) Last observation carried forward was used for missing data. (2) The Least
Squares (LS) Mean treatment difference and p-value is created via an ANCOVA
model with treatment as the fixed effect and baseline as the covariate.

Table 2: Serum phosphorus was controlled over the 52-week SAP. Subjects were
titrated to goal (3.5 to 5.5 mg/dL). There was no statistical or clinical
difference between the two groups in managing serum phosphorus over 52 weeks.

Serum Phosphorus (mg/dL)
                         Zerenex N=281 Active Control N=146
Mean (SD)(1)
Day 0 (Study Baseline)   7.4 (1.6)     7.6 (1.7)
Week 12                  5.4 (1.5)     5.3 (1.6)
Week 24                  5.3 (1.6)     5.5 (1.5)
Week 36                  5.2 (1.5)     5.3 (1.6)
Week 52                  5.4 (1.6)     5.4 (1.6)

(1) Last observation carried forward was used for missing data.

Table 3 - Secondary Endpoint: Zerenex increases serum ferritin as compared to
Active Control.

Serum Ferritin (ng/mL)
                              Zerenex N=252 Active Control N=135
Mean (SD)(1)
Day 0 (Study Baseline)        593 (293)     609 (308)
Week 12                       751 (384)     649 (326)
Week 24                       846 (416)     652 (304)
Week 36                       862 (443)     631 (328)
Week 52                       898 (489)     624 (361)

Treatment Difference P-Value2 p<0.0001      

(1) Last observation carried forward was used for missing data. (2) P-value of
treatment difference is created via an ANCOVA model with treatment as the
fixed effect and baseline as the covariate.

Table 4 - Secondary Endpoint: Zerenex increases TSAT as compared to Active
Control.

TSAT (%)
                                Zerenex N=252 Active Control N=135
Mean (SD)(1)
Day 0 (Study Baseline)          31 (11)       31 (12)
Week 12                         40 (16)       31 (12)
Week 24                         40 (15)       31 (12)
Week 36                         40 (16)       30 (11)
Week 52                         39 (17)       30 (11)

Treatment Difference P-Value(2) p<0.0001      

(1) Last observation carried forward was used for missing data. (2) P-value of
treatment difference is created via an ANCOVA model with treatment as the
fixed effect and baseline as the covariate.

Dr. Lewis noted that TSAT and ferritin scores in the Zerenex arm achieved a
statistical plateau, in regard to TSAT levels at Week 12 and to ferritin
levels at Week 36, compared to Week 52 (end of the SAP).

Table 5 - Secondary Endpoint: Zerenex decreases IV Iron use as compared to
Active Control.

Cumulative IV Iron Use          Zerenex N=272 Active Control N=137
Median Daily Intake (mg/day)(1) 1.86           3.84
% Decrease                      -52%

Treatment Difference P-Value(2) p<0.0001

(1) IV iron intake is calculated as the total IV iron intake during the study
divided by the total number of days on study drug during the study. (2)
P-value of treatment difference utilizes two-sided Wilcoxon Rank Sum Test.

Table 6: Zerenex reduces the need for IV Iron (p<0.0001) as compared to Active
Control.

% of Subjects Off IV iron Zerenex Active Control
Last 9 Months of Study    42%     11%
Last 6 Months of Study    58%     24%

Table 7 - Secondary Endpoint: Zerenex decreases ESA use as compared to Active
Control.

Cumulative ESA Use                 Zerenex N=272 Active Control N=141
Median Daily Intake (units/day)(1) 756            993
% Decrease                         -24%

Treatment Difference P-Value(2)    p<0.05

(1) ESA intake is calculated as the total ESA intake during the study divided
by the total number of days on study drug during the study. (2) P-value of
treatment difference utilizes two-sided Wilcoxon Rank Sum Test.

Table 8: Hemoglobin well-maintained with Zerenex in the SAP as compared to
Active Control despite significantly lower IV iron and ESA use.

Hemoglobin (g/dL)
                                Zerenex N=245 Active Control N=132
Mean (SD)(1)
Day 0 (Study Baseline)          11.6 (1.2)    11.7 (1.2)
Week 12                         11.8 (1.4)    11.5 (1.3)
Week 24                         11.6 (1.4)    11.4 (1.2)
Week 36                         11.5 (1.4)    11.3 (1.2)
Week 52                         11.4 (1.5)    11.1 (1.4)

Treatment Difference P-Value(2) P<0.05        

(1) Last observation carried forward was used for missing data. (2) P-value of
treatment difference is created via an ANCOVA model with treatment as the
fixed effect and baseline as the covariate.

Study Safety Results

Dr. Lewis indicated that Zerenex was safe and well-tolerated in the study and
provided the below additional safety data.

Table 9: Zerenex arm incurred a lower rate of serious adverse events (SAEs) as
compared to Active Control.

Deaths, SAEs and notable SAEs by System Order       Zerenex     Active Control
Class(1)
Subjects exposed to Study drug (n)                  289         149
Deaths, n (%)                                       13 (4.5%)   8 (5.4%)
Subjects with an SAE, n (%)                         114 (39.4%) 73 (49.0%)
Infections and Infestations, n (%)                  36 (12.5%)  27 (18.1%)
Vascular Disorders, n (%)                           22 (7.6%)   14 (9.4%)
Gastrointestinal Disorders, n (%)                   20 (6.9%)   18 (12.1%)
Cardiac Disorders, n (%)                            20 (6.9%)   17 (11.4%)

(1) Subjects may have more than one SAE.

Ron Bentsur, the Company's Chief Executive Officer, commented, "The data
presented at WCN corroborates the top-line data presented earlier this year
and further highlights Zerenex's highly-differentiated product profile. We
believe that Zerenex, if approved, can potentially change practice patterns in
dialysis and chronic kidney disease and improve patients' lives." Mr. Bentsur
added, "We look forward to the presentations of additional data from the study
at upcoming medical conferences."

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), 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 end-stage renal disease, conducted pursuant
to a Special Protocol Assessment (SPA) agreement with the FDA, and the New
Drug Application filing with the FDA and the Marketing Authorization
Application filing with the EMA are pending submission. Zerenex is also in
Phase 2 development in the U.S. for the management of 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, and the clinical benefits to be
derived from Zerenex (ferric citrate), as well as 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: risks related to the timing
for submission of the NDA and MAA and whether the FDA and EMA, respectively,
will accept such submissions for review following submission and ultimately
approve them; whether the FDA and EMA will concur with the our interpretation
of our Phase 3 study results or the conduct of the study; whether, if Zerenex
receives approval, it will be successfully distributed 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.

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

Website: http://www.keryx.com
 
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