Rockwell Medical to Host Conference Call and Webcast with Management and Key Opinion Leaders to Discuss Potential Novel Indic...
September 09 2020 - 8:00AM
Rockwell Medical, Inc. (Nasdaq: RMTI) ("Rockwell Medical" or the
“Company”), a biopharmaceutical company dedicated to transforming
the treatment of iron deficiency and anemia management and
improving outcomes for patients around the world, today
announced it will host a conference call and webcast on Thursday,
September 24, 2020, at 4:30 p.m. ET to discuss potential novel
applications of ferric pyrophosphate citrate (FPC), the active
pharmaceutical ingredient in Triferic®, for the treatment of iron
deficiency anemia in patients undergoing home infusion therapy and
iron deficiency in patients with acute heart failure. The call and
webcast will include representatives from Rockwell Medical as well
as key opinion leaders (KOLs) Connie Sullivan, B.S. Pharm,
President and CEO of the National Home Infusion Association, and
Inder Anand, M.D., F.R.C.P., D.Phil. (Oxon), Emeritus Professor of
Medicine at the University of Minnesota Medical School and Former
Director of the Heart Failure Program at VA Medical Center in
Minneapolis.
"My charge as CEO is to actualize the potential
of our FPC technology, for patients and for shareholders,” said
Russell Ellison, M.D., M.Sc., President and Chief Executive Officer
of Rockwell Medical. “I believe there is potential for important
value creation through the development of the FPC platform to treat
medical conditions with unmet clinical needs outside of the
hemodialysis setting. The team at Rockwell Medical and independent
leading experts in the field look forward to providing a more
fulsome update on the market potential and the clinical development
plans, for such new potential indications on the conference call
and webcast later this month.”
To access the conference call, please dial (888)
317-6003 (local) or (412) 317-6061 (international) at least 10
minutes prior to the start time and refer to conference ID 5330503.
A live webcast of the call will be available under "Events &
Presentations" in the Investor section of the Company's website,
https://ir.rockwellmed.com/. An archived webcast will be available
on the Company's website approximately two hours after the event
and will be available for 30 days.
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 kidney disease
(ESKD). Rockwell Medical's exclusive renal drug
therapies, Triferic (ferric pyrophosphate citrate) Dialysate and
Triferic AVNU (ferric pyrophosphate citrate injection), 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%).
Triferic® is a registered trademark
of Rockwell Medical, Inc.
CONTACTS
Investors: Argot Partners 212.600.1902
Rockwell@argotpartners.com
Media: David Rosen Argot Partners 212.600.1902
david.rosen@argotpartners.com
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