Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company") today
announced the publication of Auryxia™ (ferric citrate) data and
expert analyses in two peer-reviewed journals. An analysis of the
effect of Auryxia on intravenous (IV) iron and
erythropoiesis-stimulating agent (ESA) dosage and utilization was
published online today in the Journal of the American Society of
Nephrology (JASN). Auryxia was approved by the U.S. Food and Drug
Administration in September 2014 for the control of serum
phosphorus levels in chronic kidney disease (CKD) patients on
dialysis.
The publication in JASN, titled "Ferric Citrate Reduces
Intravenous Iron and Erythropoiesis-Stimulating Agent Use in ESRD"
was led by Kausik Umanath, MD, Division of Nephrology and
Hypertension at Henry Ford Hospital. The analysis was based on the
Phase 3 long-term safety and efficacy trial of Auryxia in
dialysis-dependent CKD patients. The primary data from this study
was published in 2014 in the Journal of the American Society of
Nephrology.
Separately, an expert analysis was also recently published
online in Expert Review of Pharmacoeconomics & Outcomes
Research. The review titled "Phosphorus Binding with Ferric Citrate
Is Associated with Fewer Hospitalizations and Reduced
Hospitalization Costs" was published online in Expert Review of
Pharmacoeconomics & Outcomes Research and was led by Roger A.
Rodby, MD, Division of Nephrology, Rush University Medical Center.
This post-hoc analysis was based on the Phase 3 long-term safety
and efficacy trial of Auryxia in dialysis-dependent chronic kidney
disease patients.
About End Stage Renal Disease (ESRD) and
Hyperphosphatemia
End-stage renal disease (ESRD) represents the most severe stage
of CKD, as many metabolic factors, such as iron and phosphorus, are
out of balance. The majority of ESRD patients require chronic
treatment with phosphate-binding agents to lower and maintain serum
phosphorus at acceptable levels. In addition, iron can be severely
depleted in dialysis patients and they therefore are often treated
with intravenous iron and other medications. Approximately 450,000
ESRD patients require dialysis in the U.S., with the number
projected to rise in the future.
About Auryxia™ (ferric citrate)
Auryxia™ (ferric citrate) was approved by the U.S. Food and Drug
Administration on September 5, 2014 and is indicated in the U.S.
for the control of serum phosphorus levels in patients with chronic
kidney disease (CKD) on dialysis. The U.S. approval of Auryxia was
based on data from the Company's Phase 3 registration program. In
the Phase 3 clinical trials, Auryxia effectively reduced serum
phosphorus levels to within the KDOQI guidelines range of 3.5 to
5.5 mg/dL.
Auryxia binds with dietary phosphate in the GI tract, and forms
non-absorbable complexes which are excreted. Auryxia has been shown
to increase serum iron parameters including ferritin and
transferrin saturation (TSAT), whereas these parameters remained
relatively constant in patients treated with active control
(Renvela® and/or Phoslo®). Iron absorption from Auryxia may lead to
excessive elevations in iron stores. Accordingly, physicians should
assess and monitor iron parameters before starting and while on
Auryxia, and may need to decrease or discontinue IV iron for these
patients. The most common adverse events for Auryxia treated
patients were gastrointestinal-related, including diarrhea, nausea,
vomiting and constipation.
For more information about Auryxia,
visit www.Auryxia.com.
For Full Prescribing Information for Auryxia, please visit
http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Auryxia (ferric citrate) Important Safety
Information
Contraindication: Patients with iron
overload syndrome, e.g. hemochromatosis, should not take Auryxia
(ferric citrate).
Iron Overload: Iron absorption from
Auryxia may lead to increased iron in storage sites. Iron
parameters should be monitored prior to and while on Auryxia.
Patients receiving IV iron may require a reduction in dose or
discontinuation of IV iron therapy.
Accidental Overdose of Iron: Accidental
overdose of iron containing products is a leading cause of fatal
poisoning in children under 6 years of age. Keep Auryxia away
from children as it contains iron. Call a poison control center or
your physician in case of an accidental overdose in a child.
Patients with Gastrointestinal Bleeding or
Inflammation: Safety has not been established for
these patients.
Adverse Events: The most common adverse
events with Auryxia were diarrhea (21%), nausea (11%), constipation
(8%), vomiting (7%) and cough (6%). Gastrointestinal adverse
reactions were the most common reason for discontinuing Auryxia
(14%).
Auryxia contains iron and may cause dark stools, which is
considered normal with oral medications containing iron.
Drug Interactions: Doxycycline should be
taken at least 1 hour before Auryxia.
For Full Prescribing Information for Auryxia, please
visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused
on bringing innovative therapies to market for patients with renal
disease. In December 2014, the Company launched its first
FDA-approved product, Auryxia (ferric citrate) for the treatment of
elevated serum phosphorus levels in patients with chronic kidney
disease on dialysis, in the United States. 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® by Keryx's
Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co.
Ltd. For more information about Keryx, please visit
www.keryx.com.
Cautionary Statement
Some of the statements included in this press release,
particularly those relating to the results of clinical trials or
the commercialization and subsequent clinical development of
Auryxia (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: the risk that we may not be
successful in the development of ferric citrate for the treatment
of iron deficiency anemia in non-dialysis chronic kidney disease
patients; whether Auryxia will be successfully launched and
marketed in the U.S.; whether Riona® will be successfully marketed
by our Japanese partner, Japan Tobacco, Inc. and Torii
Pharmaceutical Co., Ltd; the risk that the EMA may not concur with
our interpretation of the results from our Phase 3 studies in ESRD,
Phase 2 study in non-dialysis dependent CKD, supportive studies,
conduct of the studies, or any other part of our MAA submission and
could ultimately deny approval of the MAA; and other risk factors
identified from time to time in our reports filed with
the Securities and Exchange Commission, 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. 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,
or on the websites of the American Journal of Kidney
Diseases the National Kidney Foundation, or
the Journal of the American Society of Nephrology, is not
incorporated by reference into this press release and is included
for reference purposes only.
CONTACT: Amy Sullivan, Vice President - Corporate Development
and Public Affairs
Keryx Biopharmaceuticals, Inc.
Tel: 617.466.3447
E-mail: amy.sullivan@keryx.com
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