Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, today announced that the U.S. Food and Drug Administration
(“FDA”) has approved its New Drug Application (“NDA”) for its
intravenous formulation of Triferic, Triferic AVNU. With this
approval, Triferic AVNU joins Triferic Dialysate as the only
FDA-approved products indicated to replace iron and maintain
hemoglobin in adult patients with hemodialysis-dependent chronic
kidney disease.
Triferic is a novel, physiologic iron maintenance therapy that
provides bioavailable iron to replace iron lost during every
dialysis treatment and maintain hemoglobin. While Triferic
Dialysate is designed to be administered via liquid bicarbonate,
Triferic AVNU is designed for direct intravenous infusion, which
provides hemodialysis patients with greater access to the Triferic
platform and expands administration options for clinicians.
Triferic AVNU can be administered regardless of a dialysis center’s
mode of bicarbonate delivery. Many dialysis centers in
international markets and an increasing number of dialysis centers
in the U.S. have converted to the use of dry bicarbonate cartridges
or bags and on-line dialysate generation, which is not compatible
with Triferic Dialysate.
“The approval of Triferic AVNU is a major milestone as we
further progress toward our goal of transforming anemia management
across the globe. With Triferic AVNU, more adult hemodialysis
patients in the U.S will have access to the benefits of this unique
therapeutic, regardless of the way their clinic generates
bicarbonate. Clinicians will now have the added flexibility to
administer Triferic intravenously to a broader group of patients
who can benefit from physiologic iron maintenance therapy to manage
their anemia,” stated Stuart Paul, President and Chief Executive
Officer of Rockwell Medical.
“Clinical trials have demonstrated that patients treated with
Triferic receive steady and consistent bioavailable iron to replace
the iron that is lost at every dialysis treatment and hemoglobin is
maintained. Now, even in clinics where delivering Triferic through
the dialysate is not operationally possible, Triferic AVNU is an
option. This may be especially important for patients who are
difficult to manage, or for other special patient populations,”
added Dr. Steven Fishbane, Chief of Nephrology of Northwell Health
and Professor of Medicine at the Zucker School of Medicine.
Over the next several months, the Company plans to initiate a
commercial strategy that leverages the experience gained from the
2019 launch of Triferic Dialysate and lays the groundwork for the
commercial introduction of Triferic AVNU. The Company expects to
launch Evaluation Programs during the third quarter of 2020 to
allow clinics to gain direct experience with Triferic AVNU, and the
Company expects Triferic AVNU to be available commercially
following the completion of the initial Evaluation Programs.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company dedicated to
transforming anemia management in a wide variety of therapeutic
areas and across the globe, improving the lives of very sick
patients. The Company’s initial focus is the treatment of anemia in
end-stage renal disease (ESRD). Rockwell Medical's exclusive renal
drug therapy, Triferic (ferric pyrophosphate citrate), is the only
FDA-approved therapeutic indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. 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.
About Triferic
Triferic is the only FDA-approved therapy in the U.S. indicated
to replace iron and maintain hemoglobin in hemodialysis patients
during each dialysis treatment. Triferic has a unique and
differentiated mechanism of action which has the potential to
benefit patients and health care economics. Triferic represents a
potential innovative medical advancement in hemodialysis patient
iron management– with the potential to become the future standard
of care. The Company has two FDA-approved formulations of Triferic
(1) Triferic Dialysate and (2) Triferic AVNU.
Triferic delivers between 5-7 mg iron with every hemodialysis
treatment to the bone marrow and maintains hemoglobin without
increasing iron stores (ferritin). 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 1,000,000 patient administrations,
addressing a significant medical need in overcoming Functional Iron
Deficiency (FID) in ESRD patients.
Important Safety Information
Serious 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%).
Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the federal
securities laws, including, but not limited to, Rockwell Medical’s
expectations regarding the consummation of the offering, the terms
of the offering, and the satisfaction of customary closing
conditions with respect to the offering and the anticipated use of
the net proceeds of the offering. Words such as “may,” “might,”
“will,” “should,” “believe,” “expect,” “anticipate,” “estimate,”
“continue,” “could,” “plan,” “potential,” “predict,” “forecast,”
“project,” “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 issuance of a unique J code for our
Triferic powder packet; timing and regulatory approval process for
Triferic Dialysate in China; the potential market and
commercialization opportunity of Triferic Dialysate in China
upon regulatory approval; the timing, as well as commercialization
opportunity and process for Triferic AVNU; the potential domestic
and international market opportunity for Triferic AVNU, as well as
other Rockwell Medical products; CMS’ announced final rule relating
to the eligibility criteria for TDAPA; liquidity and capital
resources; expected duration of Rockwell Medical’s existing working
capital; the success of our commercialization of Triferic
Dialysate, which commenced in May 2019; and the timing and success
of our efforts to maintain, grow and improve the profit margin of
the Company’s concentrate business; and the impact of general
economic, industrial or political conditions, as well as recent
health conditions in the United States or internationally, as well
as those risks more fully discussed in Rockwell Medical’s SEC
filings. Accordingly, you should not place undue reliance on these
forward-looking statements. 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.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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