Rockwell Update on Calcitriol Post-Approval Manufacturing Submission to FDA
25 October 2017 - 11:30PM
Rockwell Medical, Inc. (NASDAQ:RMTI), today provided an update on
the commercial launch of Calcitriol, stating that the FDA has
requested extra time to review its post-approval drug manufacturing
submission that was filed with the FDA September 28, 2017. The FDA
was required to provide Rockwell with a determination on its
September 28th submission within 30 days. The Company expects to
have an answer from the FDA in approximately four months.
Calcitriol is Rockwell’s FDA approved active Vitamin D injection
for the management of hypocalcemia in patients undergoing chronic
renal dialysis. Rockwell intends to sell Calcitriol commercially
once the FDA approves its post-approval drug manufacturing
submission
“We believe the Agency required more time to
review the submission package than the 30-day window required,”
stated Raymond Pratt, MD, Chief Medical Officer of Rockwell. “Our
data remains robust. We will also submit additional helpful data
that we have gathered since our initial submission September 28,
2017.”
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.
Michael Rice, Investor Relations;
646-597-6979Triferic® is a registered trademark of Rockwell
Medical, Inc.
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