Rockwell Medical, Inc. Files New Drug Submission with Health Canada for Marketing Approval of Triferic AVNU

WIXOM, Mich., May 26, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming anemia management and improving outcomes for patients around the world, today announced the filing of a New Drug Submission (“NDS”) with Health Canada for Triferic AVNU (ferric pyrophosphate citrate). The Company seeks an indication to promote Triferic AVNU in Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The filing is the first international regulatory submission for the intravenous therapy.

“Our submission to Health Canada reflects an important milestone for our Company as well as for the more than 20,000 Canadians undergoing hemodialysis,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “Rockwell Medical is focused on transforming the treatment of iron deficiency and anemia around the world to improve outcomes for patients. If approved by Health Canada, 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 Canada, through which Rockwell Medical will receive a transfer price based on Triferic sales in Canada, subject to Canadian regulatory approval.

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 renal disease (ESRD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, 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.