Rockwell Medical, a biopharmaceutical company focused on improving the lives of patients with iron deficiency and other neglected diseases, announced that its partner, Jeil Pharmaceutical, has received acceptance from the Korean Ministry of Food and Drug Safety for its partner’s product, Triferic AV, which is marketed in the US. As part of the deal, Jeil becomes the exclusive distributor of Triferic in South Korea, and Rockwell Medical will be the manufacturer of the drug. The agreement provides Jeil with an upfront fee and royalties on net sales.
The approval by the Korean Ministry of Food and Drug Safety is a significant event for Rockwell Medical, and it is the first time that a new drug has been approved for the treatment of patients undergoing hemodialysis in South Korea. Triferic AVNU and Triferic DM are the only approved iron replacement therapies in the US. Their unique mechanism of action has the potential to improve the lives of hemodialysis patients. Triferic AVNU and Triferic DM deliver around 5-7 mg of iron to replace the loss of iron stores caused by the continuous use of hemodialysis. Both formulations also donate iron to the bone marrow for transfusion.