Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), 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 the appointment of industry leader and renowned
life science industry executive, Ms. Andrea Heslin Smiley, to its
Board of Directors, effective December 11, 2020. Ms. Smiley
currently serves as President and Chief Executive Officer of VMS
BioMarketing and is a member of the Board of Directors of life
science company, Assertio (formerly Zyla Life Sciences).
“We are pleased to welcome Andrea to the Board
of Directors,” said John P. McLaughlin, Chairman of the Board of
Directors of Rockwell Medical. “Andrea brings a wealth of
experience in patient adherence and outcomes, clinical educator
solutions, nursing networks, and pharmaceutical product launches
and marketing. She will be a valuable advisor in maximizing the
value of Triferic® in kidney disease and our FPC technology in home
infusion and heart failure.”
"I am delighted to join Rockwell Medical’s Board
of Directors at this exciting time for the Company, especially as
we plan to move into the rapidly growing home infusion market,"
said Ms. Smiley.
Ms. Smiley brings approximately three decades of
commercialization and general management experience in the
biopharmaceutical industry in both public and private companies.
She joined VMS BioMarketing, a leading provider of patient and
healthcare provider support, in 2008, and has served as its
President and Chief Executive Officer since 2011. Within her first
year as CEO, she spun-off commoditized business units and focused
the company on impacting patient adherence and outcomes, all the
while establishing VMS BioMarketing as the leading provider and
growth leader of clinical nurse educator patient support solutions.
Prior to joining VMS BioMarketing, Ms. Smiley spent 18 years at Eli
Lilly and Company in various positions of increasing responsibility
in finance, business development, corporate affairs, brand
management and business unit leadership roles. She was the
marketing leader for the launch of Humalog® Mix75/25™, she led
sales and marketing for Humatrope®, she was responsible for the
development and launch of Forteo® and she was the business unit
leader of Lilly’s women’s health business, among other programs.
Earlier in her career, Ms. Smiley worked as a management consultant
for Putnam Associates, where she led consulting teams and advised
brands in the biotechnology, pharmaceutical and managed healthcare
fields on product launches and access strategies. She is a regular
speaker and panel member on patient adherence, patient services and
women’s leadership topics at biopharmaceutical industry
conferences. Ms. Smiley serves on the board of numerous nonprofit
organizations including the Indiana Alzheimer’s Association, Summer
Stock, Indiana Salvation Army and the Lung Force Women’s Cabinet.
She received a gubernatorial appointment to the Indiana Commission
for Women. Ms. Smiley earned her Bachelor of Arts degree in
economics from DePauw University, where she was an Honors
Management Fellow.
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 (ESKD). Rockwell
Medical's exclusive renal drug therapies, Triferic (ferric
pyrophosphate citrate) Dialysate and Triferic AVNU, are the only
FDA-approved therapeutics 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 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 the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which 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 ESKD 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, the
commercialization of Triferic Dialysate, the launch of Triferic
AVNU, the development plans and timing for Rockwell Medical’s FPC
pipeline candidates including but not limited to the potential
application of FPC within the home infusion market, and the
commercialization of future FPC pipeline candidates in other
therapeutic areas. 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 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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