Trial with over 400 Patients Conducted by
Partner Wanbang Pharmaceuticals, a Subsidiary of Fosun
Pharma
Over 600,000 Patients receive Hemodialysis in
China
WIXOM,
Mich., April 25, 2022 /PRNewswire/ --
Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company
dedicated to transforming the treatment of iron deficiency and
anemia management, today announced that its partner, Wanbang
Biopharmaceuticals enrolled the final patient, ahead of
schedule, in its pivotal Phase 3 clinical trial for
Triferic® (ferric pyrophosphate citrate) Dialysate to support
a new drug application for regulatory approval in China. Wanbang Biopharmaceuticals is a
subsidiary of Shanghai Fosun Pharmaceutical (Group) Co.,
Ltd. ("Fosun Pharma"), which is on the
Forbes Global 2000 list of the world's largest
publicly-traded companies.
"This is a major milestone toward approval of Triferic Dialysate
in China," commented Russell Ellison, M.D., M.Sc., President and CEO
of Rockwell Medical. "Initiated in January of last year, the trial
has now enrolled a total of 442 patients at sites across the
country. With over 600,000 patients receiving hemodialysis,
China represents an enormous
potential market opportunity for Rockwell, as we execute on our
strategic plan to expand global access to Triferic."
Fosun Pharma is targeting submitting a New Drug Approval (NDA)
submission to China's National
Medical Products Administration (NMPA) in the third quarter of
2023.
Yongchun Zhou, Vice President at
Wanbang Biopharmaceuticals stated, "The study was discussed with
regulators from the Center for Drug Evaluation (CDE), part of the
NMPA, at a very early stage, and was designed with feedback from
those initial meetings top-of-mind. We congratulate our clinical
trial team at Wanbang Biopharmaceuticals for executing a project
plan for a complex study under challenging circumstances, and we
look forward to completion of the trial in 2023."
The Phase 3 trial ("RMFPC-13") is a prospective, randomized,
single-blind (patient), parallel two-arm, placebo-controlled,
multicenter, study of Triferic administered via hemodialysate in
Chinese CKD-5HD (hemodialysis) patients. The objective of the study
is to confirm the efficacy and safety of Triferic administered at
each hemodialysis treatment via hemodialysate in maintaining
hemoglobin in Chinese CKD-5HD patients. Rockwell Medical signed
exclusive licensing and manufacturing supply agreements with
Wanbang Biopharmaceuticals for the rights to commercialize Triferic
in China in 2016.
About Rockwell Medical
Rockwell Medical is a
commercial-stage biopharmaceutical company developing and
commercializing its next-generation parenteral iron technology
platform, Ferric Pyrophosphate Citrate (FPC), which has the
potential to lead transformative treatments for iron deficiency in
multiple disease states, reduce healthcare costs and improve
patients' lives. The Company has two FDA-approved therapies
indicated for patients undergoing hemodialysis, which are the first
two products developed from the FPC platform. Rockwell
Medical is also advancing its FPC platform by developing FPC
for the treatment of iron deficiency anemia in patients outside of
dialysis, who are receiving intravenous medications in the home
infusion setting. In addition, Rockwell Medical is one of
two major suppliers of life-saving hemodialysis concentrate
products to kidney dialysis clinics in the United States. For more information,
visit www.RockwellMed.com.
Forward-Looking Statements
Certain statements in this
press release may constitute "forward-looking statements" within
the meaning of the federal securities laws. Words such as, "may,"
"might," "will," "should," "believe," "expect," "anticipate,"
"estimate," "continue," "could," "can," "would," "develop," "plan,"
"potential," "predict," "forecast," "project," "intend," "look
forward to" 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
those risks more fully discussed in the "Risk Factors" section of
our Annual Report on Form 10-K for the year ended December 31,
2021, 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.
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SOURCE Rockwell Medical, Inc.