Keryx Biopharmaceuticals Announces U.S. FDA Approval of Second Contract Manufacturer for Auryxia® (ferric citrate)
November 09 2016 - 10:42AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced that the U.S. Food and Drug
Administration (FDA) has approved its application for a second drug
product contract manufacturer. Patheon Manufacturing Services LLC
of Greenville, North Carolina, a leading global provider of
pharmaceutical manufacturing services, is now an FDA approved drug
product manufacturer of Auryxia®. With FDA approval of this
manufacturer, the company has rebuilt supply and will promptly make
Auryxia available to wholesalers.
“We are pleased with today’s approval, as it expands our
manufacturing capabilities and capacity,” said Greg Madison,
president and chief executive officer of Keryx Biopharmaceuticals.
“Getting a second drug product manufacturer approved was an
important step to ensuring long-term supply of Auryxia is
consistently available to patients.”
Mr. Madison continued, “We are looking forward to attending
American Society of Nephrology’s Kidney Week, the global, premier
kidney conference. The timing of this conference next week gives us
the opportunity to communicate with health care professionals in
attendance that Auryxia supply is restored and is once again
available for their patients.”
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 StatementsSome 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, 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 resupply the
market with Auryxia following approval of the Patheon facility and
our ability to sustain that supply; 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; 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, Strategic Operations and Corporate 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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