Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
“Company”), a global biopharmaceutical company dedicated to
improving outcomes for patients with anemia, with an initial focus
on end-stage renal disease (ESRD) and chronic kidney disease (CKD),
today announced the commencement of commercial sales of Dialysate
Triferic® in the United States.
Triferic is a novel therapeutic platform for the treatment of
anemia that replaces ongoing iron losses by a process similar to
that of normal iron metabolism. Triferic is the first and only
FDA-approved iron replacement therapy indicated to maintain
hemoglobin levels in hemodialysis patients. Its unique and
physiologic mechanism of action, excellent safety profile, and
potential pharmacoeconomic benefits offer healthcare providers a
new alternative in the treatment of anemia in
hemodialysis-dependent CKD patients.
The Company has developed multiple formulations of Triferic for
the treatment of anemia in adult hemodialysis patients and is now
launching the first product, Dialysate Triferic, from its
portfolio. The Company expects to file a New Drug Application with
the U.S. Food and Drug Administration (FDA) for its next
formulation, I.V. Triferic, within the second quarter of 2019.
“Dialysate Triferic is an innovative physiological alternative
to existing IV iron formulations,” said Marcos Rothstein, M.D.,
Professor of Medicine in the Division of Nephrology at Washington
University School of Medicine in St. Louis. “Dialysate Triferic
does not increase iron stores. It has had no cases of anaphylaxis
and the infection rate is similar to placebo. Additionally, in
patients with reticuloendothelial (RE) block, it overcomes
functional iron deficiency.”
“We are excited to launch Dialysate Triferic, the first
therapeutic in our Triferic portfolio. Our short-term objectives
include increasing awareness of Triferic within the dialysis
community, building and enhancing relationships with key opinion
leaders, and supporting medical education of nephrologists and
other clinicians, while generating real-world evidence to support
the use of Triferic in adult hemodialysis patients. These efforts
are geared towards achieving future and sustained acceptance of
Triferic as part of the standard of care in anemia management, and
supporting our broader Triferic portfolio,” said Stuart Paul,
President and Chief Executive Officer of Rockwell Medical.
The Company is initially executing a multi-pronged commercial
and medical education approach for Dialysate Triferic, with a focus
on dialysis centers that were part of its trial program, as well as
select medium-sized, small and independent dialysis organizations
that constitute approximately 25% of the U.S. market. Based on the
expected sales cycle at dialysis clinics, the Company does not
expect material sales for Dialysate Triferic in the second quarter
of 2019.
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment. Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Unlike
traditional IV iron products, Triferic donates iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood and is then transported directly to the bone marrow
to be incorporated into hemoglobin, with no increase in ferritin
(stored iron and inflammation) and no reports of anaphylaxis in
over 675,000 patient administrations, addressing a significant
medical need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mode-of-action (MOA) video and for more information.
Important Safety InformationSerious
hypersensitivity reactions, including anaphylactic-type reactions,
some of which have been life-threatening and fatal, have been
reported in patients receiving parenteral iron products. Patients
may present with shock, clinically significant hypotension, loss of
consciousness, and/or collapse. Monitor patients for signs and
symptoms of hypersensitivity during and after hemodialysis until
clinically stable. Personnel and therapies should be immediately
available for the treatment of serious hypersensitivity reactions.
Hypersensitivity reactions have been reported in 1 (0.3%) of 292
patients receiving Triferic in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples.
Post dialysis serum iron parameters may overestimate serum iron and
transferrin saturation.
The most common adverse reactions (≥3% and at least 1% greater
than placebo) in controlled clinical studies include: procedural
hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in
extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back
pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%),
asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula
thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
For more information, including full prescribing information,
visit: http://www.triferic.com.
About Rockwell Medical, Inc. Rockwell Medical
is a specialty pharmaceutical company targeting end-stage renal
disease (ESRD) and chronic kidney disease (CKD) with innovative
therapies and products. Rockwell Medical'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. The Company
has developed multiple formulations of Triferic, the only
FDA-approved therapeutic indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. The Company’s
strategy is to bring its therapeutics to market in the United
States and to utilize partners to develop and commercialize such
therapeutics in international markets. Rockwell Medical is also an
established manufacturer, supplier and leader in delivering
high-quality hemodialysis concentrates/dialysates to dialysis
providers and distributors in the U.S. and abroad. Please visit
www.rockwellmed.com for more information.
Forward-Looking Statement Certain statements in
this press release may constitute "forward-looking statements"
within the meaning of the federal securities laws. Words such as
"may," "might," "will," "should," "believe," "expect,"
"anticipate," "estimate," "continue," "could," "plan," "potential,"
"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), many of which are beyond
our control and subject to change. Actual results could be
materially different. Risks and uncertainties include: statements
about the degree of success in marketing Dialysate Triferic, the
timing and success of our planned NDA submission for I.V. Triferic;
the potential market opportunity for I.V. Triferic and other
Rockwell Medical products; pricing and reimbursement status for
I.V. Triferic, Triferic and other Rockwell Medical products,
including eligibility for add-on reimbursement under TDAPA;
liquidity and capital resources; expected duration of Rockwell
Medical's existing working capital; plans and timing relating to
the planned commercialization of Triferic; and timing and success
of our efforts to renegotiate economic terms of our concentrate
business Rockwell Medical expressly disclaims any obligation to
update or alter any statements whether as a result of new
information, future events or otherwise, except as required by
law.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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