Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
"Company"), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, announced today the appointment of pharmaceutical industry
leader Robert (“Bob”) S. Radie to its Board of Directors, effective
March 31, 2020.
“We are pleased to welcome Bob to the Rockwell Medical Board of
Directors. Having led numerous companies from their development
stage through commercialization, Bob brings deep expertise from the
pharmaceutical and biotech industries, with significant executive,
commercial, business development and clinical development
experience. Bob will be a great asset to Rockwell Medical as we
ensure that our novel therapeutic, Triferic® (ferric pyrophosphate
citrate), is widely available to hemodialysis patients around the
world who can benefit, and further develop our platform for anemia
patients with other diseases,” stated John P. McLaughlin, Chairman
of the Board of Directors of Rockwell Medical.
“I am delighted to join Rockwell Medical’s Board at this
exciting time and to help the Company realize the full potential of
its iron maintenance therapy, Triferic. I look forward to working
with management and current Board members to achieve Rockwell
Medical’s goal of transforming the way anemia is managed in a
variety of disease states,” said Mr. Radie.
Mr. Radie brings more than three decades of industry experience,
working in both public and private pharmaceutical and biotech
companies across a range of therapeutic areas. He has held senior
executive positions in six companies, including serving as Chief
Executive Officer of Zyla Life Sciences, Topaz Pharmaceuticals,
Inc., which was sold to Sanofi Pasteur, and Transmolecular, Inc.
Mr. Radie also served as Chief Business Officer at Prestwick
Pharmaceuticals, Inc., which was sold to Biovail Pharmaceutics;
Morphotek, Inc., which was sold to Eisai Co., Ltd.; and Senior Vice
President of Strategy and Planning at Vicuron Pharmaceuticals,
Inc., which was sold to Pfizer for $1.9 billion in 2005. Mr. Radie
began his career at Eli Lilly and Company where he worked for 18
years in sales and marketing positions with increasing levels of
responsibility.
Mr. Radie currently holds several Board positions, including
Paratek Pharmaceuticals, a public biopharmaceutical company; LPSA,
the Pennsylvania industry advocacy group; and Horse Power for Life,
a non-profit organization dedicated to improving the quality of
life for individuals diagnosed with cancer. He previously served on
the Boards of Veloxis Pharmaceuticals, which was recently acquired
by Asahi Kasei Corp. for $1.3 billion, and Affinium
Pharmaceuticals, a private specialty pharmaceutical company.
Mr. Radie received his B.S. in Chemistry from Boston
College.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company dedicated to
transforming 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 renal disease (ESRD). Rockwell Medical's exclusive renal
drug therapy, Triferic (ferric pyrophosphate citrate), is the only
FDA-approved therapeutic indicated for iron replacement and
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
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 has a unique
and differentiated mechanism of action which has the potential to
benefit patients and health care economics. Triferic represents a
potential innovative medical advancement in hemodialysis patient
iron management– with the potential to become the future standard
of care. The Company has two FDA-approved formulations of
Triferic (1) Triferic Dialysate and (2) Triferic AVNU.
Triferic delivers approximately 5-7 mg iron with every
hemodialysis treatment to the bone marrow and maintains hemoglobin
without increasing iron stores (ferritin). 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.
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.
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, Rockwell Medical’s
expectations regarding the consummation of the offering, the terms
of the offering, and the satisfaction of customary closing
conditions with respect to the offering and the anticipated use of
the net proceeds of the offering. Words such as “may,” “might,”
“will,” “should,” “believe,” “expect,” “anticipate,” “estimate,”
“continue,” “could,” “plan,” “potential,” “predict,” “forecast,”
“project,” “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; timing and regulatory approval process for
Triferic Dialysate in China; the potential market and
commercialization opportunity of Triferic Dialysate in China upon
regulatory approval; the timing, as well as commercialization
opportunity and process for Triferic AVNU; the potential domestic
and international market opportunity for Triferic AVNU, as well as
other Rockwell Medical products; CMS’ announced final rule relating
to the eligibility criteria for TDAPA; liquidity and capital
resources; expected duration of Rockwell Medical’s existing working
capital; the success of our commercialization of Triferic
Dialysate, which commenced in May 2019; and the timing and success
of our efforts to maintain, grow and improve the profit margin of
the Company’s concentrate business; and the impact of general
economic, industrial or political conditions, as well as recent
health conditions in the United States or internationally, as well
as those risks more fully discussed in Rockwell Medical’s SEC
filings. Accordingly, you should not place undue reliance on these
forward-looking statements. 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.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
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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