Rockwell Medical to Present Data on Peritoneal Dialysis (PD) Administration of Triferic at American Society of Nephrology (AS...
October 19 2016 - 8:30AM
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated
biopharmaceutical company targeting end-stage renal disease (ESRD)
and chronic kidney disease (CKD) with innovative products for the
treatment of iron replacement, secondary hyperparathyroidism and
hemodialysis, announced today that it will present data on the
toxicology of Triferic administered intraperitoneally to rats at
ASN Kidney Week 2016 Annual Meeting, November 15-20 at the
McCormick Place in Chicago, IL. Triferic is the Company’s
iron-replacement drug for the treatment of iron deficiency in
chronic kidney disease patients receiving dialysis.
The study will be presented as a poster on
Saturday, November 19, 2016.Session Title: Peritoneal Dialysis –
ISession Date and Time: November 19, 2016 at 10:00 a.m.Poster #:
SA-PO1089
Rob Chioini, Chairman and CEO of Rockwell
Medical stated, “This study demonstrates Triferic’s potential to be
an effective iron replacement therapy for patients receiving
peritoneal dialysis. Peritoneal dialysis sales are currently
estimated to be $600M in the U.S., and $3B worldwide. This
toxicology study was the last step prior to initiating our clinical
program for Peritoneal Dialysis. We plan to start a dose finding
study in humans on PD in Q1 of 2017.”
About TrifericTriferic is the
only FDA approved drug indicated to replace iron and maintain
hemoglobin in hemodialysis patients suffering from anemia. Via
dialysate during each dialysis treatment, Triferic replaces the 5-7
mg iron loss that occurs in all patients, effectively maintaining
their iron balance. Unlike IV iron products, Triferic binds iron
immediately and completely to transferrin (carrier of iron in the
body) upon entering the blood and it is then transported directly
to the bone marrow to be incorporated into hemoglobin, with no
increase in ferritin (stored iron and inflammation) and no
anaphylaxis, addressing a significant unmet need in overcoming
Functional Iron Deficiency (FID) in ESRD patients. Please visit
www.triferic.com for more information.
About Rockwell MedicalRockwell
Medical is a fully-integrated biopharmaceutical company targeting
end-stage renal disease (ESRD) and chronic kidney disease (CKD)
with innovative products and services for the treatment of iron
replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell’s recent FDA approved drug
Triferic is indicated for iron replacement and maintenance of
hemoglobin in hemodialysis patients. Triferic delivers iron to
patients during their regular dialysis treatment, using dialysate
as the delivery mechanism. Triferic has demonstrated that it safely
and effectively delivers sufficient iron to the bone marrow and
maintains hemoglobin, without increasing iron stores (ferritin).
Rockwell intends to market Triferic to hemodialysis patients in the
U.S. dialysis market and globally.
Rockwell’s FDA approved generic drug Calcitriol
is for treating secondary hyperparathyroidism in dialysis patients.
Calcitriol (active vitamin D) injection is indicated in the
management of hypocalcemia in patients undergoing chronic renal
dialysis. It has been shown to significantly reduce elevated
parathyroid hormone levels. Reduction of PTH has been shown to
result in an improvement in renal osteodystrophy. Rockwell
intends to market Calcitriol to hemodialysis patients in the U.S.
dialysis market.
Rockwell is also an established manufacturer and
leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in
the U.S. and abroad. As one of the two major suppliers in the U.S.,
Rockwell’s products are used to maintain human life by removing
toxins and replacing critical nutrients in the dialysis patient’s
bloodstream. Rockwell has three U.S. manufacturing and distribution
facilities.
Rockwell’s exclusive renal drug therapies
support disease management initiatives to improve the quality of
life and care of dialysis patients and are intended to deliver safe
and effective therapy, while decreasing drug administration costs
and improving patient convenience. Rockwell Medical is developing a
pipeline of drug therapies, including extensions of Triferic for
indications outside of hemodialysis. Please visit
www.rockwellmed.com for more information.
Certain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws, including, but not limited to, Rockwell’s
intention to sell and market Calcitriol and Triferic. Words such as
“may,” “might,” “will,” “should,” “believe,” “expect,”
“anticipate,” “estimate,” “continue,” “predict,” “forecast,”
“project,” “plan,” “intend” or similar expressions, or statements
regarding intent, belief, or current expectations, are
forward-looking statements. While Rockwell Medical believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties,
including without limitation those set forth in Rockwell Medical’s
SEC filings. Thus, actual results could be materially different.
Rockwell Medical expressly disclaims any obligation to update or
alter statements whether as a result of new information, future
events or otherwise, except as required by law.
Triferic® is a registered trademark of Rockwell
Medical, Inc.
Michael Rice, Investor Relations; 646-597-6979
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