Keryx Biopharma (KERX) Partner Filed NDA in Japan for CKD Treatment; Receives $7M Milestone
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Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) announced that its Japanese partner, Japan Tobacco Inc. (JT), has filed its New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare for marketing approval of ferric citrate in Japan for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). The NDA filing is supported by efficacy and safety data from several successfully completed Phase 3 studies in CKD patients with hyperphosphatemia in Japan.
Under the license agreement with JT and its subsidiary Torii Pharmaceutical Co., Ltd. (Torii), within 30 days, Keryx will receive a non-refundable payment of $7 million for the achievement of the NDA filing milestone.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "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." Mr. Bentsur continued, "We eagerly await our top-line results from our U.S. long-term Phase 3 study in dialysis patients and the anticipated U.S. NDA and European MAA filings which will follow suit."
Zerenex™ (ferric citrate), a ferric iron-based phosphate binder, has recently completed a long-term Phase 3 study, under Special Protocol Assessment, as a treatment for end-stage renal disease patients with hyperphosphatemia on dialysis, and the top-line data from this Phase 3 study is expected to be announced imminently. Zerenex is also being explored in a Phase 2 study in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 CKD not on dialysis.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to JT and Torii.
Under the license agreement with JT and its subsidiary Torii Pharmaceutical Co., Ltd. (Torii), within 30 days, Keryx will receive a non-refundable payment of $7 million for the achievement of the NDA filing milestone.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "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." Mr. Bentsur continued, "We eagerly await our top-line results from our U.S. long-term Phase 3 study in dialysis patients and the anticipated U.S. NDA and European MAA filings which will follow suit."
Zerenex™ (ferric citrate), a ferric iron-based phosphate binder, has recently completed a long-term Phase 3 study, under Special Protocol Assessment, as a treatment for end-stage renal disease patients with hyperphosphatemia on dialysis, and the top-line data from this Phase 3 study is expected to be announced imminently. Zerenex is also being explored in a Phase 2 study in managing serum phosphorus and iron deficiency in anemic patients with Stage 3 to 5 CKD not on dialysis.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex (ferric citrate) from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to JT and Torii.
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