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 the positive results of two clinical pharmacology
trials of Triferic (ferric pyrophosphate citrate) in China.
Rockwell Medical and its partner, Wanbang Biopharmaceuticals
(Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group)
Co., Ltd., expect to request a meeting with the National Medical
Products Administration (NMPA) (formerly, China Food and Drug
Administration or CFDA) to review the results of these studies and
discuss whether these studies are sufficient to support a
submission for regulatory approval for Dialysate Triferic.
The first study was conducted in healthy volunteers to assess
the pharmacokinetics of Triferic in the Chinese population. Serum
iron levels were assessed in 12 healthy subjects during a baseline
period and after a 4-hour infusion of Triferic 6.5 mg
intravenously. Data from this study suggest that when
compared to Triferic administered to healthy western (U.S.)
subjects, PK parameters in Chinese subjects were similar.
Although Chinese subjects have a lower lean body mass as compared
to western subjects, plasma clearance of the administered Triferic
iron was the same.
The second study, conducted in Chinese hemodialysis (HD)
patients, assessed the Triferic iron delivery via dialysate.
This was a 12 patient two-period crossover study. The PK
parameters assessed included serum iron and transferrin saturation
(TSAT). Data from this study suggest that administration of
Dialysate Triferic in this population shows the same iron transfer
as demonstrated in western (U.S.) hemodialysis patients. When
compared to U.S. HD patients, Chinese HD patients had a lower lean
body mass, but the clearance of Triferic iron was the
same.
“We are very encouraged by the results of the two studies.
Triferic was well tolerated in both studies with no new safety
issues identified. If approved, Triferic could be
available in China, one of the largest and fastest growing ESRD
markets in the world. This would follow our launch of
Dialysate Triferic in the U.S. earlier this year, and significantly
expand our global Triferic portfolio,” said Stuart Paul, President
and Chief Executive Officer of Rockwell Medical.
In 2016, the Company licensed the commercialization rights for
Dialysate Triferic for the Chinese market to Wanbang.
Pursuant to Rockwell Medical’s license agreement with Wanbang, the
Company is entitled to receive up to $35.0 million of regulatory
and sales-based milestone payments, including an $8.0 million
milestone payment upon regulatory approval of Triferic in China.
Rockwell Medical will supply the finished dosage form of Triferic
to Wanbang at transfer price comprising cost of goods sold, mark-up
and a percentage of net sales in the low-to-mid 20% range. Under
the terms of the licensing agreement, Wanbang is responsible for
the cost of the clinical trials and regulatory approval program in
China. Rockwell Medical retains manufacturing responsibilities for
Triferic for China.
The People’s Republic of China has one of the largest ESRD
populations in the world, with more than 400,000 hemodialysis
patients. The Company anticipates that commercial sales activity in
this market will commence following regulatory or registration
approval.
About Triferic Triferic is the only
FDA-approved therapy in the U.S. 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 1,000,000 patient administrations,
addressing a significant medical need in overcoming Functional Iron
Deficiency (FID) in ESRD patients. The Company has developed
multiple formulations of Triferic: (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.
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 timing and
regulatory approval process for Dialysate Triferic in China before
the NMPA; potential market opportunity and commercialization of
Dialysate Triferic in China, as well as for other Rockwell Medical
products; the timing and the regulatory approval process of the FDA
for I.V. Triferic; pricing and reimbursement status for I.V.
Triferic, and other Rockwell Medical products including the
eligibility of I.V. Triferic for add-on reimbursement under TDAPA,
pursuant to 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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