Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the
"Company"), a biopharmaceutical company dedicated to improving
outcomes for patients with anemia, with an initial focus on
end-stage renal disease (ESRD) and chronic kidney disease (CKD),
today announced that it has completed the submission of its New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) for the Intravenous (I.V.) formulation of Triferic®.
Earlier this month, the Company announced the launch of the
first product from its portfolio, Dialysate Triferic. Dialysate
Triferic is mixed with liquid bicarbonate to deliver iron to
patients via the dialysate, while I.V. Triferic is designed to be
administered to patients intravenously. As a result, if approved,
I.V. Triferic would allow dialysis centers to administer Triferic
to patients regardless of the mode of bicarbonate delivery being
used.
“This is an exciting time for Rockwell Medical, as this NDA
follows on quickly to our recent commercial launch of Dialysate
Triferic. The infrastructure we are building to support Dialysate
Triferic will lay the groundwork for advancing this important
addition to the Triferic platform, if approved. Subject to Centers
for Medicare & Medicaid (CMS) approval, I.V. Triferic
will be eligible for reimbursement under the Transitional Drug
Add-On Payment Adjustment (TDAPA), meaning dialysis clinics would
be eligible to receive separate payments from Medicare for a period
of 24 months,” said Stuart Paul, President and Chief Executive
Officer of Rockwell Medical.
“We believe there is a significant unmet medical need among
patients who receive hemodialysis treatments, and an important
opportunity to change the standard of care by offering dialysis
clinics and patients safe and effective options for maintaining
hemoglobin. We also see a substantial global market for I.V.
Triferic, as many dialysis providers in large international markets
predominantly use bicarbonate bags or cartridges comprising dry
powder, and I.V. Triferic would integrate well with their existing
protocols,” added Mr. Paul.
I.V. Triferic for adult hemodialysis patients was developed
pursuant to a Special Protocol Assessment (SPA), through which the
FDA agreed that an equivalence approach to Triferic delivered via
hemodialysate (Dialysate Triferic) would be acceptable for review.
The NDA is supported by data from the Company’s equivalence study,
which demonstrated that I.V. Triferic delivers the same quantity of
iron to patients as the Company’s FDA-approved Dialysate Triferic
formulation. An open-label, randomized, multiple-period single dose
study was conducted to establish the equivalence of doses between
dialysate and I.V. administration. Results of this study were
presented at the Annual Dialysis Conference (“ADC”) on March 18,
2019.
Information regarding the I.V. Triferic Study Abstract presented
at ADC can be found in the Press Release dated March 18, 2019.
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment. Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Unlike
traditional IV iron products, Triferic donates iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood and 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 675,000 patient administrations, addressing a significant
medical need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mode-of-action (MOA) video and for more information.
Important Safety InformationSerious
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%).
For more information, including full prescribing information,
visit: http://www.triferic.com.
About Rockwell Medical, Inc. Rockwell Medical
is a biopharmaceutical company dedicated to improving outcomes for
patients with anemia, with an initial focus on end-stage renal
disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical's
exclusive renal drug therapy, Triferic, supports disease management
initiatives to improve the quality of life and care of dialysis
patients and is intended to deliver safe and effective therapy,
while decreasing drug administration costs and improving patient
convenience. The Company has developed multiple formulations of
Triferic (Dialysate Triferic and I.V. Triferic). Triferic is the
only FDA-approved therapeutic indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. The Company’s
strategy is to bring its therapeutics to market in the United
States and to utilize partners to develop and commercialize such
therapeutics in international markets. 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. Please visit
www.rockwellmed.com for more information.
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 bring to market
Triferic, and I.V. Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "plan", "intend" or 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: statements about the issuance of a
unique J code for our Triferic Powder Packet; the period of review
and approval by the FDA of our NDA submission for I.V. Triferic;
the potential market opportunity for I.V. Triferic and other
Rockwell Medical products; pricing and reimbursement status for
I.V. Triferic, Dialysate Triferic and other Rockwell Medical
products, including, subject to the approval of CMS, the
eligibility of I.V. Triferic for add-on reimbursement under TDAPA;
liquidity and capital resources; expected duration of Rockwell
Medical's existing working capital; success of our recently
announced commercialization plans for Dialysate Triferic; and
timing and success of our efforts to renegotiate economic terms of
our concentrate business Rockwell Medical expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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