NEW YORK, Dec. 22, 2014 /PRNewswire/ -- Keryx
Biopharmaceuticals, Inc. (Nasdaq: KERX) (the "Company") today
announced it has begun shipping AURYXIA™ (ferric citrate) tablets
to wholesalers in the U.S. Auryxia is approved for the
control of serum phosphorus levels in patients with chronic kidney
disease (CKD) on dialysis. Auryxia is the first and only
absorbable-iron-based phosphate binder that is clinically proven to
effectively control phosphate levels within the KDOQI guidelines
range of 3.5 mg/dL to 5.5 mg/dL. The U.S. Food and Drug
Administration (FDA) approved Auryxia in September 2014. For more information visit
http://www.auryxia.com/.
"We are extremely proud to bring Auryxia to market in the U.S.
Auryxia is a new treatment option for nephrologists that fits
squarely into their current treatment protocols," said Ron Bentsur, Chief Executive Officer of Keryx.
"We have built a world-class renal commercial team at Keryx and are
eager to deliver the first and only absorbable-iron-based phosphate
binder to dialysis patients."
"Dialysis patients and their healthcare providers will benefit
from having an additional phosphate binder available," commented
Julia Lewis, MD, nephrologist and
Professor of Medicine at Vanderbilt
University Medical Center. "Auryxia's clinical profile is
compelling and I believe will be of value for my patients."
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.
Dr. Geoffrey Block, Director of
Clinical Research at Denver Nephrology commented, "I am very
pleased to be able to offer my dialysis patients an effective new
treatment option. Unlike other phosphate binders, Auryxia is the
only absorbable-iron-based phosphate binder."
Commitment to Dialysis Patients
The Company has created the "Keryx Patient Plus" program to
assist with patient accessibility to Auryxia. Beginning at
the Company's reimbursement hub, personalized service is provided
through dedicated regional case managers to provide the renal care
team with comprehensive insurance and reimbursement support for
their patients. Keryx Patient Plus offers benefit verification,
co-pay assistance for eligible commercial patients, free-drug
program for those who qualify, and a short-term prescription bridge
program that may assist those already on Auryxia who are in danger
of suffering a break in coverage.
"Through the work of our field force and the commercialization
activities executed to date, awareness and anticipated demand for
Auryxia has continued to grow among our target audiences," said
Greg Madison, Chief Operating
Officer of Keryx. "We intend to build off that momentum to position
Auryxia as we develop the potential of this important product in
the market."
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.
The ferric iron component of Auryxia binds with dietary
phosphate in the GI tract, and precipitates as ferric phosphate.
The unbound ferric iron in 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. The Company's
FDA-approved product, Auryxia, is indicated in the United States for the control of serum
phosphorus levels in patients with chronic kidney disease on
dialysis. 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 regarding the commercialization and subsequent
clinical development of Auryxia, 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: 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 our Phase 3 study results, supportive data,
conduct of the studies, or any other part of our MAA submission and
could ultimately deny approval of the MAA; 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; 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.
KERYX 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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SOURCE Keryx Biopharmaceuticals, Inc.