Our Company Vision
Our vision is to establish a new standard of care for patients suffering with iron deficiency and iron deficiency anemia. Iron deficiency anemia afflicts a subset of the two billion people worldwide who are nutritionally iron deficientREF. Approximately 10 million people are iron deficient in the United States, including 5 million who have iron deficiency anemia.
Our Platform Technology
Ferric pyrophosphate citrate (FPC)
Our innovative therapeutic was developed to replace iron loss in patients with anemia in an entirely different way. Our unique and differentiated molecule, Ferric Pyrophosphate Citrate (FPC), provides a novel mechanism of action with a physiologic approach. FPC donates iron directly to circulating transferrin making it immediately bioavailable for critical body processes, which allows the body to use the iron in a physiologic manner.
FPC is introduced to the blood
FPC donates iron directly and completely to transferrin – providing bioavailable iron for red blood cell production
FPC avoids iron sequestration in liver and other healthy tissues
Transferrin-bound iron immediately delivered to bone marrow for hemoglobin formation
FPC delivers 100% bioavailable iron to maintain hemoglobin
FPC is introduced to the blood
FPC donates iron directly and completely to transferrin – providing bioavailable iron for for red blood cell production
FPC avoids iron sequestration in liver and other healthy tissues
Transferrin-bound iron immediately delivered to bone marrow for hemoglobin formation
FPC delivers the desired amount of iron maintenance over time
This novel approach to the treatment of iron deficiency and anemia has the potential for application in many disease states.
Our initial area
of focus
Renal Disease
The first disease state we are focused on is End-stage Renal Disease, specifically patients on hemodialysis. There are over 2 million people on dialysis worldwide, including over half million in the United States alone. Blood loss and iron sequestration are leading causes of anemia in hemodialysis patients. Anemia in hemodialysis patients is caused by insufficient production of red blood cells as a result of progressive kidney failure, compounded by blood loss occurring during weekly dialysis treatments.
The first formulation of our proprietary technology is approved by the FDA under the brand name TRIFERIC. A new formulation for intravenous infusion, also for hemodialysis patients, was approved by the FDA in 2020 under the brand name TRIFERIC AVNU.
TRIFERIC is the first and only FDA-approved product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
TRIFERIC is a novel physiologic approach to iron maintenance - delivering bioavailable iron to replace what is lost at every dialysis treatment, resulting in hemoglobin stability.REF
Learn moreImportant Safety Information for TRIFERIC
Indication
TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Limitations of Use
TRIFERIC is not intended for use in patients receiving peritoneal dialysis. TRIFERIC has not been studied in patients receiving home hemodialysis.
Warnings and Precautions
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.
Adverse Reactions
Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.
To report an Adverse Events (AE) or Product Quality Control (PQC) please call the Medical Information Department at (855) 333-4315 or e-mail at rockwell.pharmacovigilance@propharmagroup.com.
For more information, please see full Prescribing Information.
Triferic AVNU is designed for direct intravenous infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians.
Triferic AVNU can be administered regardless of a dialysis center’s mode of bicarbonate delivery. Many dialysis centers in international markets and an increasing number of dialysis centers in the U.S. have converted to the use of dry bicarbonate cartridges or bags and on-line dialysate generation, which is not compatible with Triferic Dialysate.
Learn moreImportant Safety Information for TRIFERIC AVNU
Indication
TRIFERIC AVNU (ferric pyrophosphate citrate for injection) is an iron-replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Warnings and Precautions
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.
Adverse Reactions
Most common adverse reactions (incidence ≥3%) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.
For full Safety and Prescribing Information please visit www.Trifericavnu.com.
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