Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that
the European Commission has approved Fexeric® (ferric citrate
coordination complex) for the control of elevated serum phosphorus
levels, or hyperphosphatemia, in adults with chronic kidney disease
(CKD), including both dialysis and pre-dialysis patients. The
European Commission considered ferric citrate coordination complex
a New Active Substance, which provides 10 years of data and
marketing exclusivity in Europe.
"We are pleased that this medicine was approved for broad use,
in both the pre-dialysis and dialysis settings, to control
hyperphosphatemia in adults with chronic kidney disease," said John
Neylan, M.D., chief medical officer of Keryx. "Importantly, the EU
product information contains data that is reflective of Fexeric's
full clinical profile, including all of the primary and secondary
endpoint data from the Phase 3 study. With Fexeric's broad label,
nephrologists have a new, well tolerated and effective phosphate
binder to control hyperphosphatemia as the patient progresses
through the late stages of CKD and into dialysis."
"The differentiated profile of ferric citrate will be a new
treatment option for our patients on dialysis and pre-dialysis,"
said Gilbert Deray, MD, Professor of Nephrology at Université Paris
6 Pierre et Marie Curie in Paris and Nephrologist and Head of the
Department of Nephrology at Pitié-Salpêtrière University Hospital.
"I look forward to using this medicine to control phosphorus levels
when it becomes available in the E.U."
The European Commission's decision is based on evidence from
approximately 1900 patients, including two key clinical trials: a
Phase 2, non-dialysis study and a 58-week, Phase 3 registration
trial. In the Phase 3 trial, ferric citrate effectively reduced
serum phosphorus levels to within the KDOQI guidelines range of 3.5
mg/dL to 5.5 mg/dL (p<0.0001), the primary endpoint. These data
were published in 2014 in the Journal of the American Society of
Nephrology.
"EC approval is another validation by a global regulatory agency
of the medicine's profile, and is another milestone in our efforts
to expand the reach of ferric citrate to treat patients with renal
disease," said Greg Madison, chief executive officer. "We continue
to work with potential partners regarding commercialization in the
EU, and expect to finalize our commercial strategy by the end of
2015."
The most commonly reported adverse reactions in
dialysis-dependent CKD patients during treatment were discolored
feces (18%) and diarrhea (13%). All serious adverse reactions were
gastrointestinal in nature (abdominal pain, constipation, diarrhea,
gastritis, gastritis erosive, and hematemesis). The most commonly
reported adverse reactions in CKD non-dialysis patients during
treatment were discolored feces (27%) constipation (13%) and
diarrhea (11%).
Ferric citrate coordination complex was approved under the brand
name Auryxia™ by the U.S. Food and Drug Administration in September
2014, and is indicated in the U.S. for the control of serum
phosphorus levels in patients with chronic kidney disease on
dialysis. Keryx is conducting a Phase 3 study to potentially expand
the label in the U.S. to treat iron deficiency anemia in
pre-dialysis patients with chronic kidney disease.
ABOUT HYPERPHOSPHATEMIA IN CHRONIC KIDNEY
DISEASE
In the five major markets in Europe (EU5), there are currently
estimated to be approximately 1.3 million people diagnosed and
treated with stages 3-5 CKD, and approximately 750,000 of these
people are estimated to have hyperphosphatemia. In the U.S.,
Auryxia is currently indicated for 450,000 people with
hyperphosphatemia and end stage renal disease (stage 5) who require
dialysis.
ABOUT HYPERPHOSPHATEMIA
Managing patients on dialysis is complex as many metabolic
factors, such as iron and phosphorus, are out of balance. Phosphate
retention and resulting hyperphosphatemia in dialysis patients are
typically associated with increased risk for heart and bone
disease, and death. The majority of dialysis 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 dialyzed patients, who are often
treated with intravenous iron and/or anemia medications, such as
erythropoiesis stimulating agents (ESAs), to help boost red blood
cell production.
The Summary of Product Characteristics for Fexeric will be
available at www.keryx.com through October 30, 2015, and will be
available on the European Medicines Agency website at
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003776/smops/Positive/human_smop_000859.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA™ (ferric
citrate)
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. Ciprofloxacin should be
taken at least 2 hours before or after 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, with offices in New York and Boston,
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 STATEMENTS
Some of the statements included in this press release,
particularly those regarding the approval and subsequent
commercialization of Fexeric, 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
we will able to identify and negotiate acceptable terms with a
commercialization partner in the EU; whether we or a partner can
successfully launch Fexeric in the EU; 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 BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Vice President, Corporate Development and Public Affairs
T: 617.466.3519
amy.sullivan@keryx.com
Lora Pike
Senior Director, Investor Relations
T: 617.466.3511
lora.pike@keryx.com
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