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), today announced the appointment of
John P. McLaughlin as its Chairman of the Board, effective
immediately. Mr. McLaughlin, who joined the Board on September 5,
2019, succeeds Benjamin Wolin, who will remain on the Board of
Directors.
“This is a truly pivotal time for Rockwell Medical with the
recent commercial launch of Dialysate Triferic® (ferric
pyrophosphate citrate) and the filing for approval of I.V.
Triferic. I am honored to serve as Chairman of the Board of
Directors and look forward to working with the rest of Rockwell
Medical’s talented Board and management team as the Company works
to transform anemia management in a variety of disease states
around the globe and establish Triferic as the standard of care for
anemia management in ESRD patients. We are grateful to Ben for his
service as Chairman, and we are excited that he will remain an
active member of the Board,” said John P. McLaughlin, Chairman of
the Board.
Mr. McLaughlin currently also serves on the Board of PDL
BioPharma, Inc. where he was Chief Executive Officer for 10 years;
Noden Pharma DAC, a Dublin-based pharma company that commercializes
hypertension drugs worldwide; and Lensar Inc., a medical technology
company that commercializes lasers for refractive cataract surgery
worldwide. He has previously co-founded and sold, as well as served
on the boards of, a number of biotechnology and medical technology
companies.
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 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 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 of
Triferic: (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 of
data readouts; the timing for the ruling from CMS; potential market
opportunity for I.V. Triferic, as well as other Rockwell Medical
products; 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 of 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.
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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