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),
announced today that the U.S. Food and Drug Administration (FDA)
has accepted for filing the Company’s New Drug Application (NDA)
for its Intravenous (I.V.) formulation of TRIFERIC® with a PDUFA
(Prescription Drug User Fee Act) date of March 28, 2020.
In May 2019, the Company launched 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 for intravenous administration to
patients. 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.
“We are pleased to announce the FDA’s acceptance of our I.V.
Triferic NDA. This announcement follows shortly after the
commercial launch of Dialysate Triferic. If approved, the I.V.
formulation would complement Dialysate Triferic and expand the
global market potential of our Triferic portfolio,” said Stuart
Paul, President and Chief Executive Officer of Rockwell
Medical.
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 Company’s 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. The Company has developed multiple formulations: (1)
FDA-approved Dialysate Triferic; and (2) I.V. Triferic, for which
the Company filed a New Drug Application in May 2019 with a PDUFA
date of March 28, 2020. 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: (1)
Dialysate Triferic; and (2) I.V. Triferic. Dialysate 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 about the Company.
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, the eligibility of I.V. Triferic for add-on
reimbursement under TDAPA under CMS’ preliminary proposed rules as
announced by CMS on July 29, 2019; 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
maintain, grow and improve the profit margin of the Company’s
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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