Rockwell Medical Announces Growth Plan and New Therapeutic Opportunities for Its Ferric Pyrophosphate Citrate (FPC) Platform

-New indications for FPC platform provide significant growth opportunity-

-Anticipates Type C meeting with FDA for home infusion in Q1 2021 and for acute heart failure in 2H 2021-

-Well capitalized to fund dialysis business and advance clinical development for home infusion indication-

-Archived webcast available on corporate website-

WIXOM, Mich., Sept. 24, 2020 (GLOBE NEWSWIRE) -- 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, earlier today concluded its Management and Key Opinion Leader (KOL) conference call and webcast to discuss potential novel indications for its ferric pyrophosphate citrate (FPC) platform. The conference call included presentations by Rockwell Medical executive management and 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.

“Earlier today, Rockwell Medical and independent leading experts laid out the pathway for potential important value creation for the Company through the development of the FPC platform to treat medical conditions with unmet clinical needs outside of the hemodialysis setting. This exciting new development plan for FPC, along with increasing adoption of Triferic for dialysis patients, are evidence of Rockwell Medical’s continued focus on our vision – to transform the treatment of iron deficiency and anemia for the millions of people affected worldwide,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “FPC for the treatment of iron deficiency anemia (IDA) in home infusion patients is our top development priority, which we view as a tractable clinical development project with relatively low safety risk given our extensive safety database of FPC, and low efficacy risk given our expertise and experience in the use of parenteral iron for the treatment of IDA. We expect to hold a Type C meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 to discuss the program further. We are well capitalized to fund our existing dialysis business and advance clinical development for a home infusion indication, and we expect opportunities for multiple data read-outs and milestone reports from the home infusion program over the next three years as we advance the program through Phase II clinical proof-of-concept development.”