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Rockwell Medical Announces Submission of Triferic® New Drug Application in South Korea by Partner, Jeil Pharmaceutical Co., Ltd.
>82,000 patients receiving hemodialysis annually WIXOM, Mich., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical
About this update from Rockwell Medical, Inc.
[{"type":"text","content":">82,000 patients receiving hemodialysis annually\nWIXOM, Mich., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management, today announced that its partner in South Korea, Jeil Pharmaceutical Co., Ltd., filed New Drug Applications (NDA) with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic AVNU and Triferic Dialysate for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. “The NDA submissions by our partner, Jeil Pharmaceutical, is an important milestone for Rockwell Medical as well as for the more than 82,000 patients in South Korea undergoing hemodialysis,” said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. “We expect Triferic to become an important new treatment option for dialysis clinics and the patients they serve, if approved by the MFDS. We look forward to continuing our productive relationship with Jeil as they advance both Triferic presentations through the regulatory process.” In September 2020, Rockwell Medical entered into an exclusive license agreement with Jeil for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea. In consideration for the license, Rockwell Medical received an upfront fee and will be eligible for milestone payments and royalties on net sales. About Rockwell Medical Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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 kidney disease. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for 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...