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 the filing of a New Drug Submission (“NDS”)
with Health Canada for Triferic AVNU (ferric pyrophosphate
citrate). The Company seeks an indication to promote Triferic AVNU
in Canada for the replacement of iron to maintain hemoglobin in
adult patients with hemodialysis-dependent chronic kidney disease.
The filing is the first international regulatory submission for the
intravenous therapy.
“Our submission to Health Canada reflects an
important milestone for our Company as well as for the more than
20,000 Canadians undergoing hemodialysis,” said Russell Ellison,
M.D., M.Sc., President and Chief Executive Officer of Rockwell
Medical. “Rockwell Medical is focused on transforming the treatment
of iron deficiency and anemia around the world to improve outcomes
for patients. If approved by Health Canada, 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 Canada, through which Rockwell Medical will receive a
transfer price based on Triferic sales in Canada, subject to
Canadian regulatory approval.
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 therapies, Triferic (ferric pyrophosphate
citrate) Dialysate and Triferic AVNU, are the only FDA-approved
therapeutics 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 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 the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which 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 intention to commercialize Triferic Dialysate, and
Triferic AVNU. 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 about the
challenges inherent in new product development and other
indications and therapeutic areas for our products; the likelihood
of success with our NDS filing with Health Canada; the success and
of our commercialization of Triferic Dialysate, which was launched
in May 2019; the success and timing of our evaluation program for
Triferic AVNU and our commercial launch of Triferic AVNU in the
United States and Canada; the risk that topline clinical data and
real world results may not be predictive of future results; the
anticipated number of future clinics with which we may contract for
use of Triferic Dialysate; 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; 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 March 31, 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.
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Sep 2023 to Sep 2024