Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), 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 its partner in South Korea, Jeil Pharmaceutical Co., Ltd.
(“Jeil”), has received regulatory approval by the Ministry of Food
and Drug Safety (MFDS) of the Republic of Korea for Triferic
Injection (ferric pyrophosphate citrate sodium sulfate
co-precipitate hydrate injection) marketed in the United States as
Triferic AVNU (ferric pyrophosphate citrate injection) for iron
supplementation therapy and maintaining hemoglobin in adult
patients with hemodialysis-dependent chronic kidney disease.
Rockwell Medical has an exclusive license
agreement with Jeil for the rights to commercialize Triferic in
South Korea. Under the terms of the license agreement, Jeil is the
exclusive development and commercialization partner for Triferic in
South Korea. Rockwell Medical will supply the product to Jeil. In
consideration for the license, Rockwell Medical has received an
upfront fee and will be eligible for milestone payments and
royalties on net sales. Product sales are anticipated to begin in
June/July of 2022.
“The approval by MFDS is an important milestone
for Rockwell Medical, but more importantly, for the more than
82,000 patients in South Korea undergoing hemodialysis,” said
Russell Ellison, M.D., President and Chief Executive Officer of
Rockwell Medical. “With its considerable development and
commercialization capabilities and local market expertise, we
believe Jeil is well positioned to ensure that hemodialysis
patients have access to our innovative therapeutic across South
Korea. Today’s announcement marks another meaningful advancement
for Triferic, as we build our global footprint and increase the
long-term value of Triferic.”
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate (ferric pyrophosphate citrate) and Triferic
AVNU (ferric pyrophosphate citrate injection) 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 AVNU is not intended for use in patients receiving
peritoneal dialysis. TRIFERIC AVNU has 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 ReactionsMost 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.
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 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.
Rockwell Medical Forward-Looking Statements
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,”
“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 those risks more fully discussed in
the “Risk Factors” section of our Quarterly Report on Form 10-Q for
the period ended September 30, 2021 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.
ROCKWELL MEDICAL CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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