Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company
dedicated to transforming the treatment of iron deficiency and
anemia management and improving outcomes for patients around the
world, today announced that Triferic AVNU (ferric pyrophosphate
citrate injection), the intravenous (IV) formulation of Triferic,
is now available to patients in the United States. Triferic AVNU
was approved by the U.S. Food and Drug Administration (FDA) in
March 2020 and is indicated for the replacement of iron to maintain
hemoglobin in adult patients with hemodialysis-dependent chronic
kidney disease (HDD-CKD).
“The commercial availability of Triferic AVNU is
good news for patients with chronic kidney disease on hemodialysis
and their healthcare providers. This IV formulation is an important
line extension of Triferic Dialysate,” said Russell Ellison, M.D.,
M.Sc., President and Chief Executive Officer of Rockwell Medical.
“With Triferic AVNU, more patients will have access to the benefits
of Triferic as providers will have added flexibility to administer
the IV formulation to their patients who may benefit from
physiologic iron maintenance therapy to manage their anemia.”
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 IV 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 online dialysate generation,
which is not compatible with Triferic Dialysate.
Triferic AVNU is available for commercial
purchase directly through Rockwell Medical and our exclusive
distributor, Metro Medical™, a Cardinal Health company, to expand
market availability and ease of ordering. Metro Medical has a long
history as a leading distributor of pharmaceuticals and medical
supplies to nephrology practices and clinic-based dialysis centers
in the U.S., the focus market for Triferic ANVU.
About Triferic Dialysate and Triferic
AVNU
Triferic Dialysate and Triferic AVNU are the
only FDA-approved therapies in the U.S. indicated to replace iron
and maintain hemoglobin in hemodialysis patients during each
dialysis treatment. Triferic Dialysate and Triferic AVNU have a
unique and differentiated mechanism of action, which has the
potential to benefit patients and health care economics. Triferic
Dialysate and Triferic AVNU represent a potential innovative
medical advancement in hemodialysis patient iron management – with
the potential to become the future standard of care.
Triferic Dialysate and Triferic AVNU both
deliver approximately 5-7 mg iron with every hemodialysis treatment
to replace the ongoing losses to maintain hemoglobin without
increasing iron stores. Both formulations donate iron immediately
and completely to transferrin (carrier of iron in the body), which
is then transported to the bone marrow to be incorporated into
hemoglobin. Because of this unique mechanism of action, there is no
increase in ferritin (a measure of stored iron). Triferic and
Triferic AVNU address a significant medical need in treating
functional iron deficiency in end-stage kidney disease
patients.
The safety profile of Triferic is similar to
placebo in controlled clinical trials in patients with end-stage
kidney disease. Since approval, there have been no safety related
changes to the product labeling.
IMPORTANT SAFETY INFORMATION FOR
TRIFERIC AND TRIFERIC AVNU
INDICATION
TRIFERIC and TRIFERIC AVNU are indicated for the
replacement of iron to maintain hemoglobin in adult patients with
hemodialysis-dependent chronic kidney disease (HDD-CKD).
Limitations of Use
TRIFERIC and TRIFERIC AVNU are not intended for
use in patients receiving peritoneal dialysis. TRIFERIC and
TRIFERIC AVNU have not been studied in patients receiving home
hemodialysis.
Warnings and Precautions
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.
Adverse Reactions
Most common adverse reactions (incidence ≥3% and
at least 1% greater than placebo) in controlled clinical studies
include: headache, peripheral edema, asthenia, AV fistula
thrombosis, urinary tract infection, AV fistula site hemorrhage,
pyrexia, fatigue, procedural hypotension, muscle spasms, pain in
extremity, back pain, and dyspnea.
To report an Adverse Events (AE) or Product
Quality Control (PQC) please call the Medical Information
Department at (855) 333-4315 or e-mail at
rockwell.pharmacovigilance@propharmagroup.com.
For full Safety and Prescribing Information
please visit www.Triferic.com and www.Trifericavnu.com.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company
dedicated to transforming iron deficiency and 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 kidney disease. Rockwell Medical's
exclusive renal drug therapies, Triferic (ferric pyrophosphate
citrate) Dialysate and Triferic AVNU, are the only FDA-approved
therapeutics indicated for 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.
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, the impact
of COVID-19 on Rockwell Medical’s business and operations, the
commercialization of Triferic Dialysate, the launch and
commercialization of Triferic AVNU, the commercialization and
applicability of Triferic AVNU in international markets, and the
development plans and timing for Rockwell Medical’s FPC pipeline
candidates. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, and
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, but are not limited to: the impact of the COVID-19
pandemic (including, applicable federal state or local orders) on
business and operating results, including our supply chain,
dialysis concentrates business, the commercial launch of Triferic
AVNU, and the ability to secure international partners; the
challenges inherent in new product development and other
indications and therapeutics areas for our products; the success of
our commercialization strategy; the success and timing of our
commercialization of Triferic Dialysate; the success and timing of
international clinical trials for Triferic Dialysate and Triferic
AVNU; the success and timing of our commercial launch of Triferic
AVNU in the United States; the ability to manufacture Triferic
Dialysate and Triferic AVNU in a cost effective manner; the
reimbursement of Triferic Dialysate and Triferic AVNU in
international markets; the success and timing of the development of
our FPC pipeline candidates, the risk that topline clinical data
and real world results may not be predictive of future results;
expected financial performance, including cash flows, revenues,
growth, margins, funding, liquidity and capital resources; and
those risks more fully discussed in the “Risk Factors” section of
our Quarterly Report on Form 10-Q for the period ended September
30, 2020 and of our Annual Report on Form 10-K for the year ended
December 31, 2019, as such description may be amended or updated in
any future reports we file with the SEC. Rockwell Medical expressly
disclaims any obligation to update our forward-looking statements,
except as may be required by law.
Triferic® is a registered trademark of Rockwell
Medical, Inc. Triferic AVNU is pending with the U.S. Patent and
Trademark Office. All other product names, logos, and brands
are property of their respective owners in the United
States and/or other countries. All company, product and
service names used on this website are for identification purposes
only. Use of these names, logos, and brands does not imply
endorsement.
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/0f76fe57-5fe6-4f9e-b2ad-b78737f253a9
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