Rockwell Medical Announces Marketing Approval of Triferic AVNU in Canada

WIXOM, Mich., April 27, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that Triferic AVNU (ferric pyrophosphate citrate injection) received a Notice of Compliance (marketing approval) from Health Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Rockwell Medical expects Triferic AVNU to become commercially available in Canada during 2022.

“The approval of Triferic AVNU by Health Canada is the first international regulatory approval for our intravenous therapy and marks important progress for our strategy to bring Triferic to markets around the world,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “There are more than 20,000 Canadians undergoing dialysis. We expect Triferic AVNU to be an important new treatment option for dialysis clinics and the patients they serve.”

Rockwell Medical has a distribution agreement with RMC Health Care, Inc., through which Rockwell Medical will receive a transfer price based on Triferic AVNU sales in Canada.

About Rockwell Medical

Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. Rockwell Medical is also advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.