Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company
dedicated to transforming the treatment of iron deficiency and iron
deficiency anemia management, today announced that its partner in
South Korea, Jeil Pharmaceutical Co., Ltd., filed New Drug
Applications (NDA) with the Ministry of Food and Drug Safety (MFDS)
of the Republic of Korea for Triferic AVNU and Triferic Dialysate
for the replacement of iron to maintain hemoglobin in adult
patients with hemodialysis-dependent chronic kidney disease.
“The NDA submissions by our partner, Jeil
Pharmaceutical, is an important milestone for Rockwell Medical as
well as for the more than 82,000 patients in South Korea undergoing
hemodialysis,” said Russell Ellison, M.D., M.Sc., President and
Chief Executive Officer of Rockwell Medical. “We expect Triferic to
become an important new treatment option for dialysis clinics and
the patients they serve, if approved by the MFDS. We look forward
to continuing our productive relationship with Jeil as they advance
both Triferic presentations through the regulatory process.”
In September 2020, Rockwell Medical entered into
an exclusive license agreement with Jeil for the rights to
commercialize Triferic in South Korea. Under the terms of the
license agreement, Jeil will be the exclusive development and
commercialization partner for Triferic in South Korea. In
consideration for the license, Rockwell Medical received an upfront
fee and will be eligible for milestone payments and royalties on
net sales.
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.
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
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).
TRIFERIC is not intended for use in patients receiving
peritoneal dialysis. TRIFERIC has not been studied in patients
receiving home hemodialysis.
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.
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.
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 receipt
milestone payments and royalties by Rockwell Medical, the timing of
product sales in South Korea, the receipt of regulatory approvals
in South Korea and the potential market opportunity for Triferic in
South Korea. 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; receipt of regulatory approval for
Triferic in South Korea; our ability to successfully launch both
formulations of Triferic which will impact Rockwell’s ability to
achieve milestones and receive royalty payments; the ability to
manufacturer the product in accordance with South Korean
regulations, anticipated market opportunity in South Korea; and
those risks more fully discussed in the “Risk Factors” section of
our Quarterly Report on Form 10-Q for the period ended June 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
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