Rockwell Medical Updates Progress on Calcitriol Commercial Launch
February 21 2017 - 9:00AM
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, today provided an update on the commercial launch
progress of Calcitriol, stating that the FDA has requested that the
Company resubmit the application for the new contract manufacturer
as a Prior Approval Supplement (PAS) and pay a fee for the Agency
review. As a result, the Company anticipates Calcitriol to become
commercially available in the U.S. market in approximately 4-6
months. Calcitriol is Rockwell’s FDA approved active Vitamin D
injection for the management of hypocalcemia in patients undergoing
chronic renal dialysis.
Dr. Raymond Pratt, Chief Medical Officer of
Rockwell stated, “Although we believe the initial submission
contained all the information FDA required, we are complying
with the Agency’s request in an effort to get Calcitriol into the
market as fast as possible.”
About Rockwell MedicalRockwell
Medical is 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.
Rockwell’s anemia drug Triferic is the only
FDA approved product 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/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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