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) received a Notice of Compliance (marketing
approval) from Health Canada for the replacement of iron to
maintain hemoglobin in adult patients with hemodialysis-dependent
chronic kidney disease. Rockwell Medical expects Triferic AVNU to
become commercially available in Canada during 2022.
“The approval of Triferic AVNU by Health Canada
is the first international regulatory approval for our intravenous
therapy and marks important progress for our strategy to bring
Triferic to markets around the world,” said Russell Ellison, M.D.,
M.Sc., President and Chief Executive Officer of Rockwell Medical.
“There are more than 20,000 Canadians undergoing dialysis. We
expect Triferic AVNU to be an important new treatment option for
dialysis clinics and the patients they serve.”
Rockwell Medical has a distribution agreement
with RMC Health Care, Inc., through which Rockwell Medical will
receive a transfer price based on Triferic AVNU sales in
Canada.
About Rockwell Medical
Rockwell Medical is a commercial-stage biopharmaceutical company
developing and commercializing its next-generation parenteral iron
technology platform, Ferric Pyrophosphate Citrate (FPC), which has
the potential to lead to transformative treatments for iron
deficiency in multiple disease states, reduce healthcare costs and
improve patients’ lives. The Company has two FDA-approved therapies
indicated for patients undergoing hemodialysis, which are the first
two products developed from the FPC platform. Rockwell Medical is
also advancing its FPC platform by developing FPC for the treatment
of iron deficiency anemia in patients outside of dialysis, who are
receiving intravenous medications in the home infusion setting. In
addition, Rockwell Medical is one of two major suppliers of
life-saving hemodialysis concentrate products to kidney dialysis
clinics in the United States. For more information, visit
www.RockwellMed.com.
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 Precaution
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.
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 intention to commercialize Triferic AVNU in Canada, the
ability to receive reimbursement in Canada, and Rockwell’s
understanding of the commercial opportunity in Canada.. 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:
statements pertaining to the launch of Triferic AVNU in Canada,
Rockwell’s ability to manufacture Triferic AVNU in a manner
consistent with forecasts, Rockwell’s understanding of the
commercial opportunity in Canada, Rockwell’s ability to receive
favorable, or any, reimbursement for Triferic AVNU in Canada, the
ability of Canadian practitioner’s to incorporate Triferic AVNU
into their treatment protocols; the expected number of annualized
treatments for Triferic Dialysate and Triferic AVNU; the potential
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 and the commercial
launch of Triferic AVNU in Canada; potential future milestone
payments and royalties under our applicable license agreements;
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,
2019 and of our Annual Report on Form 10-K for the year ended
December 31, 2020, 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
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