Rockwell Medical gains Japanese Patent Issuance for Triferic GMP Formulation

Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency anemia, secondary hyperparathyroidism and hemodialysis.

Rockwell Medical announced that it has received Japanese Patent Issuance for GMP formulation of Triferic, the Company's late-stage investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The patent covers the synthesis and formulation for Rockwell's pharmaceutical-grade Triferic formula and provides protection through July 18, 2028. Additionally, the patent may be eligible for an extension of up to 5 years due to time recovered from the regulatory process.

Triferic [previously known as Soluble Ferric Pyrophosphate (SFP)], the Company’s lead investigational drug, is a novel iron salt capable of delivering iron to the hemodialysis patient via dialysate in a physiological manner, providing continuous iron maintenance therapy for the treatment or prevention of iron deficiency anemia in dialysis patients. Triferic has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin).

The founder Chairman of Rockwell Medical stated, we are excited to receive this patent protection in Japan, one of the largest dialysis markets in the world and an important target market for Triferic. This is another important patent approval for Triferic, and further strengthens our overall IP portfolio for our novel iron-delivery technology.