Keryx Announces the Largest Medicare Part D Plan Sponsor Added Auryxia® to its Medicare Part D Plan Formularies
March 20 2017 - 7:30AM
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical
company focused on bringing innovative medicines to people with
renal disease, today announced that the nation’s largest Medicare
Part D plan sponsor has added Auryxia® (ferric citrate) to its
Medicare Part D plan formularies, effective immediately. Auryxia is
currently indicated in the U.S. for the control of serum phosphorus
levels in people with chronic kidney disease (CKD) on dialysis.
Addition to these Part D plan formularies significantly increases
unrestricted access to Auryxia for people on dialysis and their
caregivers.
“We are pleased that another large insurance
provider has recognized the value that Auryxia can bring to
patients,” said Greg Madison, president and chief executive officer
of Keryx Biopharmaceuticals. “The addition to these formularies,
which covers both the remainder of 2017 and the full year 2018,
will support continuing growth of Auryxia in dialysis as well as
ensuring that we can provide broad access to Auryxia for people
with iron deficiency anemia (IDA) and non-dialysis dependent (NDD)
CKD, pending approval of this indication later this year.”
It is estimated that there are approximately
450,000 people in the U.S. who have End Stage Renal Disease (ESRD)
and who require dialysis treatment. The majority of ESRD patients
require chronic treatment with phosphate-binding medicines to lower
and maintain serum phosphorus at acceptable levels. Medicare Part D
and commercial insurance companies cover most of the prescription
costs for people with ESRD, including the vast majority of
phosphate binder prescriptions.
Keryx is seeking a label expansion for ferric
citrate to include the treatment of iron deficiency anemia in
adults with non-dialysis dependent CKD. A supplemental new drug
application is under review by the U.S. FDA, with a Prescription
Drug User Fee Act (PDUFA) target action date of November 6, 2017
for completion.
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
dialysis patients. In the Phase 3 clinical trials, Auryxia
effectively reduced serum phosphorus levels to within the
established 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.
Use of ferric citrate in patients with NDD-CKD
and IDA, as highlighted above, is investigational and has not been
determined to be safe or efficacious.
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, the expected impact of the new formulary
coverage for Auryxia and the submission of an sNDA to
the FDA to expand the label of ferric citrate to include
the treatment of IDA in adults with stage 3-5 NDD-CKD and the
potential approval in this indication and the impact thereof on
Keryx, 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 can increase adoption of
Auryxia in patients with CKD on dialysis; the risk that expanded
formulary access to Auryxia may not lead to increased adoption or
sales; the risk that the FDA may not concur with our
interpretation of our Phase 3 study results in 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; our ability
to continue to supply Auryxia following the recent resupply to the
market; 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, Inc., with headquarters in
Boston, Massachusetts, is a commercial stage company focused on
bringing innovative medicines to people with renal disease. Keryx
developed and commercializes Auryxia® (ferric citrate), an
iron-based phosphate binder, in the U.S. Ferric citrate is
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). Keryx has
programs underway to leverage its development and commercial
infrastructure, including evaluation of iron deficiency anemia
in adults with non-dialysis depended chronic kidney disease and
in-licensing medicines for renal disease. For more information
about Keryx, please visit www.keryx.com.
KERYX BIOPHARMACEUTICALS CONTACTS:
Amy Sullivan
Senior Vice President, 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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