Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced that researchers will present new
data from a pivotal Phase 3 study of ferric citrate for the
treatment of iron deficiency anemia (IDA) in adults with
non-dialysis dependent chronic kidney disease (CKD). Researchers
will also present post-marketing analysis detailing real-world use
of Auryxia® (ferric citrate) as a treatment for hyperphosphatemia
in people with CKD on dialysis. The data will be presented in five
poster presentations at the 2016 American Society of Nephrology
(ASN) Annual Meeting being held November 15 - 20, 2016, in Chicago.
Auryxia® is currently indicated in the U.S. for the
control of serum phosphorus levels in patients with CKD on
dialysis. Abstracts of the five presentations are accessible on
ASN’s website at
https://www.asn-online.org/education/kidneyweek/archives/.
Four abstracts related to IDA will be presented
together in a poster session on Thursday, November 17, 2016 from
10:00 a.m. to 12:00 p.m. Central Time (CST).
Abstract Number:
2200Presenter: Steven Fishbane,
M.D.Title: Effects of ferric citrate in adults
with non-dialysis dependent chronic kidney disease and iron
deficiency anemia: Phase 3 Clinical Trial
Abstract Number:
3705Presenter: Glenn Chertow,
M.D.Title: Hemoglobin response to ferric citrate
in subjects with non-dialysis dependent chronic kidney disease and
iron deficiency anemia: Data from a Phase 3 clinical trial
Abstract Number:
3429Presenter: Geoffrey Block,
M.D.Title: Effects of ferric citrate on parameters
of mineral and bone metabolism in patients with non-dialysis
dependent chronic kidney disease treated for iron deficiency
anemia
Abstract Number:
3937Presenter: Pablo Pergola,
M.D.Title: Predictors of hemoglobin response to
ferric citrate in patients with non-dialysis dependent chronic
kidney disease and iron deficiency anemia
One abstract related to the treatment of
hyperphosphatemia with Auryxia in the dialysis setting will be
presented in a poster presentation on Friday, November 18, 2016
from 10:00 a.m. to 12:00 p.m. CST.
Abstract Number:
2598Presenter: Pablo Pergola,
M.D.Title: The effect of ferric citrate (Auryxia)
on serum phosphate control in dialysis patients: Real-world
data
About Auryxia 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 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 precipitates as ferric phosphate. The unbound portion of
Auryxia has been shown to increase serum iron parameters including
ferritin and transferrin saturation (TSAT). 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 and the U.S. full prescribing
information, visit www.Auryxia.com.
IMPORTANT U.S. SAFETY INFORMATION FOR
AURYXIA® (ferric
citrate)Contraindication: Patients
with iron overload syndrome, e.g. hemochromatosis, should not take
Auryxia®.
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://auryxia.com/important-safety-information/
Forward Looking Statements Some of
the statements included in this press release, particularly those
regarding the commercialization and ongoing clinical development of
Auryxia as well as the expected impact of the supply interruption
of Auryxia and the expected timing of when we will have a
sufficient supply of Auryxia to make it available to patients again
following the supply interruption, 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: our
ability to quickly and successfully identify and resolve the
production-related issue; our ability to quickly and successfully
identify and engage secondary suppliers of finished drug product;
our ability to receive FDA approval of any secondary suppliers of
finished drug product; whether we can increase adoption of Auryxia
in patients with CKD on dialysis; whether we can maintain our
operating expenses to projected levels while continuing our current
clinical, regulatory and commercial activities; whether we will
able to identify and negotiate acceptable terms with a
commercialization partner in the E.U.; whether we or a partner can
successfully launch Fexeric® in the E.U.; whether Riona will be
successfully marketed in Japan by our Japanese partner, Japan
Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the risk that the
FDA may not concur with our interpretation of our Phase 3 study
results in non-dialysis dependent (NDD) CKD, supportive data,
conduct of the studies, or any other part of our regulatory
submission and could ultimately deny approval of ferric citrate for
the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk
that if approved for use in NDD-CKD that we may not be able to
successfully market Auryxia for use in this indication; 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.
About Keryx Biopharmaceuticals,
Inc. Keryx Biopharmaceuticals, with headquarters in
Boston, is focused on bringing innovative medicines to market for
people with renal disease. In December 2014, the company launched
its first FDA-approved medicine, Auryxia® (ferric citrate) in the
United States. In January 2014, ferric citrate was approved
for use in Japan, where it is being marketed as Riona® by Keryx's
Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co.
Ltd. In September 2015, the European Commission granted European
market authorization for Fexeric® (ferric citrate coordination
complex). For more information about Keryx, please visit
www.keryx.com
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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