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Rockwell Medical Announces Regulatory Approval of Triferic® AVNU in South Korea
-Commercial launch expected in June/July 2022- -Rockwell Medical has an exclusive license agreement with Jeil Pharmaceutical Co., Ltd., for the rights to
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"-Commercial launch expected in June/July 2022- -Rockwell Medical has an exclusive license agreement with Jeil Pharmaceutical Co., Ltd., for the rights to Triferic® and Triferic® AVNU in South Korea- -More than 82,000 patients receiving hemodialysis annually in So. Korea- WIXOM, Mich., Jan. 13, 2022 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), 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 its partner in South Korea, Jeil Pharmaceutical Co., Ltd. (“Jeil”), has received regulatory approval by the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic Injection (ferric pyrophosphate citrate sodium sulfate co-precipitate hydrate injection) marketed in the United States as Triferic AVNU (ferric pyrophosphate citrate injection) for iron supplementation therapy and maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Rockwell Medical has an exclusive license agreement with Jeil for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil is the exclusive development and commercialization partner for Triferic in South Korea. Rockwell Medical will supply the product to Jeil. In consideration for the license, Rockwell Medical has received an upfront fee and will be eligible for milestone payments and royalties on net sales. Product sales are anticipated to begin in June/July of 2022. “The approval by MFDS is an important milestone for Rockwell Medical, but more importantly, for the more than 82,000 patients in South Korea undergoing hemodialysis,” said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. “With its considerable development and commercialization capabilities and local market expertise, we believe Jeil is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic across South Korea. Today’s announcement marks another meaningful advancement for Triferic, as we build our global footprint and increase the long-term value of Triferic.” About Triferic Dialysate and Triferic AVNU Triferic Dialysate (ferric pyrophosphate citrate) and Triferic AVNU (ferric pyrophosphate citrate i...