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2015-09-24

Keryx Biopharmaceuticals, Inc.: Keryx Receives European Approval for Fexeric(R) (ferric citrate coordination complex) for the Treatment of Hyperphosphatemia in

The First and Only Absorbable, Iron-Based Phosphate Binder to Treat Elevated Serum Phosphorus Levels in Both Non-Dialysis and Dialysis CKD Patients in EuropeBOSTON, Sept. 24, 2015 (GLOBE NEWSWIRE) -- 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 theJournal 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(TM) 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
atwww.keryx.comthrough October 30, 2015, and will be available on the
European Medicines Agency website
athttp://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medici...

003776/smops/Positive/human_smop_000859.jsp&mid=
WC0b01ac058001d127&source=homeMedSearch&category
=human.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA(TM) (ferric citrate)

Contraindication:
Patients with iron overload syndrome, e.g. hemochromatosis, should not take
Auryxia(TM) (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 visitwww.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 athttp://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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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Keryx Biopharmaceuticals, Inc. via Globenewswire

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