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news.Japan Tobacco (JT), Keryx Biopharmaceuticals' Japanese partner, has filed a new drug application (NDA) for the marketing approval of Ferric Citrate (Zerenex) in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.
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NDA filing was based on positive efficacy and safety data demonstrated by several Phase 3 studies conducted in CKD patients with hyperphosphatemia.
Keryx chief executive officer Ron Bentsur said, "We congratulate our partner, JT/Torii, on achieving this important and exciting milestone and we applaud the tremendous sense of purpose with which they have been developing ferric citrate in Japan."
Pursuant to the licensing contract signed with JT and its subsidiary Torii Pharmaceutical, Keryx will earn $7m non-refundable payment within 30 days for achieving milestone of NDA filing.
The top-line results from US long-term Phase 3 study of Zerenex, a ferric iron-based phosphate binder, in dialysis patients is expected shortly.