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),
today announced the appointment of John P. McLaughlin to its Board
of Directors.
Mr. McLaughlin has a strong understanding of the biotechnology
industry and over 30 years of experience relating to the
development, regulation and commercialization of pharmaceuticals,
as well as finance, corporate governance matters and strategic
alliances.
“We are delighted to welcome John to our Board of Directors.
John’s broad experience in management and board positions for
companies in the biopharmaceutical industry make him an ideal
addition to our Board. We look forward to benefiting from his
perspectives as we continue to advance and execute our business
plan,” said Benjamin Wolin, Chairman of the Board of Directors of
Rockwell Medical.
“This is an important and exciting 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 pleased to join the Board of Directors and look
forward to working with the rest of the Board and Management to
ensure that these two clinically important therapeutics are
available to all hemodialysis patients and that the healthcare
system understands the products’ efficacy, safety and
pharmaco-economic attributes. By doing so, we expect to create
meaningful value for our shareholders,” stated John McLaughlin.
Mr. McLaughlin served as Chief Executive Officer of PDL
BioPharma, Inc, from December 2008 until December 2018. Prior to
joining PDL, he was the Chief Executive Officer and a Director of
Anesiva, Inc., formerly known as Corgentech, Inc., a publicly
traded biopharmaceutical company, from January 2000 to June 2008.
From December 1997 to September 1999, Mr. McLaughlin was President
of Tularik Inc., a biopharmaceutical company. From September 1987
to December 1997, Mr. McLaughlin held a number of senior management
positions at Genentech, Inc., a biopharmaceutical company,
including Executive Vice President & General Counsel. From
January 1985 to September 1987, Mr. McLaughlin was a partner at a
Washington, D.C. law firm specializing in food and drug law and has
served as counsel to various subcommittees of the United States
House of Representatives, where he drafted several measures that
later became law.
Mr. McLaughlin has been a Director of PDL since 2008. He also
serves on the Board of Directors of Lensar, Inc., a private medical
technology company that develops and commercializes femtosec lasers
for the treatment of cataracts, and Noden Pharma, a private company
that commercializes two hypertension drugs worldwide. Lensar, Inc.
and Noden Pharma are primarily owned by PDL. Mr. McLaughlin
co-founded and served as Chairman of the Board of Eyetech
Pharmaceuticals, Inc., a publicly traded biopharmaceutical company,
which was subsequently acquired by OSI Pharmaceuticals, Inc.;
co-founded and served as a Director of Peak Surgical, Inc., a
private medical device company, until it was acquired by Medtronic
in 2011; served as a director of AxoGen, Inc., a publicly traded
biopharmaceutical company until 2014; served as a director of
Adverum Biotechnologies, Inc., a publicly traded biopharmaceutical
company, until 2016; and served as a director of Seattle Genetics,
Inc., a publicly traded biopharmaceutical company, until 2016.
Mr. McLaughlin received a B.A. from the University of Notre Dame
and a J.D. from Catholic University of America.
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, is the only FDA-approved
therapeutic indicated for iron replacement and maintenance of
hemoglobin in hemodialysis 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. 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.
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.
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 issuance of a
unique J code for our Triferic Powder Packet; timing and regulatory
approval process for Dialysate Triferic in China; the potential
market opportunity and commercialization of Dialysate Triferic in
China upon regulatory approval; timing and regulatory approval
process of our NDA filing for I.V. Triferic as filed with the
FDA; 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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