Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company
dedicated to transforming the treatment of iron deficiency and iron
deficiency anemia management and improving outcomes for patients
around the world, today announced that its partner in China,
Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun
Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a
pivotal Phase 3 trial for Triferic Dialysate to support a new drug
application for regulatory approval in that country.
“The initiation of this pivotal trial is an
important milestone in our strategic plan to expand global access
to Triferic,” said Russell Ellison, M.D., M.Sc., President and
Chief Executive Officer of Rockwell Medical. “In China,
hemodialysis has continued to increase at a rapid rate in recent
years, with more than 600,000 patients receiving hemodialysis every
year, making it the largest single market in the world. Wanbang
Biopharmaceuticals is a leading pharmaceutical company and an
outstanding partner to bring our therapy to patients in China.”
“We believe Triferic has the potential to
greatly improve the lives of patients on dialysis in China, and we
are pleased to have dosed the first patient in our pivotal trial,”
said Mr. Shibin Wu, Chief Executive Officer of Wanbang
Biopharmaceuticals. “Wanbang Biopharmaceuticals is committed to
addressing the needs of CKD patients and healthcare providers with
a comprehensive range of therapeutic options across home, in-center
and hospital dialysis settings. We value our partnership with
Rockwell Medical, and our collaboration enhances Wanbang
Biopharmaceuticals’ pipeline of innovative product candidates.”
The Phase 3 trial [RMFPC-13] is a prospective,
randomized, single-blind (patient), parallel two-arm,
placebo-controlled, multicenter, study of the efficacy and safety
of Triferic® administered via hemodialysate in maintaining iron
delivery and hemoglobin concentration in anemic adult patients with
chronic kidney disease requiring hemodialysis. The objective of the
study is to confirm the efficacy and safety of Triferic
administered at each hemodialysis treatment via hemodialysate in
maintaining iron delivery for erythropoiesis in anemic iron-replete
Chinese CKD-5HD patients.
Rockwell Medical signed exclusive licensing and
manufacturing supply agreements in 2016 with Wanbang
Biopharmaceuticals for the rights to commercialize Triferic in
China. Under the terms of the agreement, Wanbang Biopharmaceuticals
became the exclusive distributor for Triferic in China for an
initial commercial term of 10 years, with an extended term of 10 or
more years based on achievement of annual minimum purchase
requirements. Wanbang Biopharmaceuticals is required to achieve
annual minimum purchase requirements to retain exclusive
commercialization rights. In consideration for the exclusive
rights, Rockwell received an upfront fee and is entitled to a
regulatory approval milestone, revenue milestone payments, and
Rockwell is entitled to receive ongoing earnings from product sales
of Triferic and other additional Triferic therapeutic indications
that Wanbang Biopharmaceuticals may develop. In addition to the
hemodialysis indication, Wanbang Biopharmaceuticals has the
exclusive right to develop and commercialize Triferic for new
therapeutic indications for the Chinese market. Wanbang
Biopharmaceuticals is responsible for all clinical, regulatory and
marketing expenses for Triferic in China as well as development and
regulatory costs for new Triferic indications. Rockwell retains
manufacturing responsibility of all products.
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
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.
Importantly, there have been no reports of anaphylaxis in over 1.2
million patient administrations.
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, the impact
of COVID-19 on Rockwell Medical’s business and operations, patient
enrollment in a clinical trial and regulatory filings in China, the
success of Triferic Dialysate and Triferic AVNU within clinical
trials, the commercialization of Triferic Dialysate and Triferic
AVNU in China, the potential approval of Triferic and Triferic AVNU
in China, potential future sales within China and anticipated
market sizes and future growth, future milestone payments and
reliance upon approval and sales, and the development plans and
timing for Rockwell Medical’s FPC pipeline candidates in new
indications. 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, including our supply chain, and the
ability to enroll patients in clinical trials, the ability to have
governmental agencies review submissions in a timely manner, and
the ability to commercialize Triferic and Triferic AVNU; the
potential for modifications of regulatory requirements in both
internationally and domestically; the challenges inherent in new
product development and other indications and therapeutics areas
for our products; the success of our commercialization strategy;
the success and timing of our commercialization of Triferic
Dialysate and Triferic AVNU; the success and timing of
international clinical trials for Triferic Dialysate; the success
and timing of the development of our FPC pipeline candidates, the
risk that topline clinical data and real world results may not be
predictive of future results; 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 September 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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