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Bio-Pharma Development

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Bio-Pharma Development

Rockwell Medical is a biopharmaceutical company dedicated to transforming anemia management in a wide variety of therapeutic areas leveraging our proprietary Triferic® (ferric pyrophosphate citrate) platform. Rockwell Medical is initially focused on the development and commercialization of Triferic for patients with end-stage renal disease (ESRD), specifically patients on hemodialysis. Currently, Triferic in dialysate form is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in adult hemodialysis patients. Rockwell Medical has also filed a New Drug Application for an I.V. formulation of Triferic with a PDUFA date of March 28, 2020. In addition, Rockwell Medical is actively evaluating other potential applications for Triferic, both in End Stage Renal Disease and other disease states.

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%).

For more information, including full prescribing information, visit: http://www.triferic.com.