Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the "Company"), today
announced the appointment of John F. Neylan, MD to the newly
created position of Chief Medical Officer. In this role, Dr. Neylan
will be responsible for oversight of medical affairs, clinical
development and pharmacovigilence at Keryx.
"It is my pleasure to welcome John to Keryx," said Greg Madison,
President and Chief Operating Officer of Keryx. "As a nephrologist
with extensive clinical development experience, John will be an
invaluable member of the Keryx leadership team as we work to
fulfill our vision of building a leading renal
franchise."
"I am honored to be joining an organization so clearly dedicated
to improving the lives of those with kidney disorders," said Dr.
Neylan. "I look forward to working with my new colleagues as well
as the many experts around the world who are helping to bring
Auryxia™ (ferric citrate) to patients in need."
Dr. Neylan is an accomplished nephrologist, transplantation
specialist, and biopharmaceutical executive with broad-based
experience in therapeutic development, from the preclinical phase
to post-marketing development of therapies across primary care,
specialty and rare disease indications. Dr. Neylan comes to
Keryx from Genzyme Corporation, where since 2008 he served in the
capacity of Senior Vice President, Clinical Development, focusing
on specialty metabolic diseases. From 2000-2008, Dr. Neylan
served as Vice President, Research and Development for Wyeth
Research, overseeing the clinical development of transplantation
therapeutics and providing medical affairs support to the
transplant franchise.
Prior to joining industry, Dr. Neylan held prestigious positions
in academia, including Professor of Medicine at Emory University
and Assistant Professor of Medicine at UC Davis, serving at both
institutions as Medical Director of the respective Renal Transplant
Programs, with oversight of the clinical research programs. Dr.
Neylan received his BS from Duke University and his MD from Rush
Medical School in Chicago. He completed his Internal Medicine
residency at Vanderbilt University and fellowships in Nephrology
and in Transplantation and Immunogenetics at Brigham and Women's
Hospital, Harvard University. Dr. Neylan has a proven track
record for successful INDs, NDA/BLAs, and MAAs involving NCEs,
polymers, biologics and RNA-based therapeutics and has authored
more than 70 scientific manuscripts and book chapters. He is
Past-President of the American Society of Transplantation and past
Board Member of the National Kidney Foundation, and a past Industry
Representative on the FDA Cardiovascular and Renal Drugs Advisory
Committee.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, with offices in Boston and New York,
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), in the United
States. Auryxia is indicated for the control of serum phosphorus
levels in patients with chronic kidney disease who are on dialysis.
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.
About Auryxia™ (ferric citrate)
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 chronic
kidney disease (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), whereas these parameters
remained relatively constant in patients treated with active
control (Renvela® and/or Phoslo®). 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, visit www.Auryxia.com.
Auryxia™ (ferric citrate) Important Safety
Information
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.
For Full Prescribing Information for Auryxia, please
visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Cautionary Statement
Some of the statements included in this press release,
particularly those regarding the commercialization and subsequent
clinical development 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: whether
Auryxia will be successfully launched and marketed in the U.S.;
whether Riona® will be successfully marketed in Japan by our
Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co.,
Ltd; the risk that the EMA may not concur with our interpretation
of our Phase 3 study results, supportive data, conduct of the
studies, or any other part of our MAA submission and could
ultimately deny approval of the MAA; the risk that we may not be
successful in the development of Auryxia for the treatment of iron
deficiency anemia in non-dialysis dependent chronic kidney disease
patients; 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 CONTACT:
Amy Sullivan
Vice President, Corporate Development and Public Affairs
Tel: 617.466.3447
e-mail: amy.sullivan@keryx.com
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