NEW YORK, NY, USA I March 10, 2014 I Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the “Company”) today announced it has submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”), seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease (“CKD”), including dialysis- and non-dialysis dependent CKD.
The MAA will be reviewed by the EMA Committee for Medicinal Products for Human Use (CHMP) and the review will be conducted under the Centralized Authorization Procedure. An approval under the Centralized Authorization Procedure provides one marketing authorization which is valid in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
Ron Bentsur, Chief Executive Officer of Keryx, commented, “We are pleased to have submitted our MAA, seeking European approval of Zerenex for both dialysis and pre-dialysis and believe that this marks another important milestone for Keryx. We thank the EMA for their guidance and look forward to working with them over the course of the review process.”
The Company’s new drug application for Zerenex is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. In January, it was announced that the Company’s Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd. (“JT/Torii”), received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to JT/Torii.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate coordination complex), an oral, ferric iron-based compound. Keryx has completed a U.S.-based Phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease (CKD) on dialysis, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA). The Company’s New Drug Application (NDA) is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. The Company’s Marketing Authorization Application, seeking the approval of Zerenex as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, has been submitted to the European Medicines Agency (EMA). The Company is also developing Zerenex in the U.S. for the management of elevated serum phosphorus and iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent CKD. In addition, Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Keryx is headquartered in New York City.
SOURCE: Keryx Pharmaceuticals
Post Views: 31
NEW YORK, NY, USA I March 10, 2014 I Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) (the “Company”) today announced it has submitted a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”), seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease (“CKD”), including dialysis- and non-dialysis dependent CKD.
The MAA will be reviewed by the EMA Committee for Medicinal Products for Human Use (CHMP) and the review will be conducted under the Centralized Authorization Procedure. An approval under the Centralized Authorization Procedure provides one marketing authorization which is valid in all 27 member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
Ron Bentsur, Chief Executive Officer of Keryx, commented, “We are pleased to have submitted our MAA, seeking European approval of Zerenex for both dialysis and pre-dialysis and believe that this marks another important milestone for Keryx. We thank the EMA for their guidance and look forward to working with them over the course of the review process.”
The Company’s new drug application for Zerenex is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. In January, it was announced that the Company’s Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd. (“JT/Torii”), received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD.
Keryx Biopharmaceuticals retains a worldwide exclusive license (except for the Asian Pacific Region) to Zerenex from Panion & BF Biotech, Inc. The Company has sublicensed the development of ferric citrate in Japan to JT/Torii.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals focuses on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease. Keryx is developing Zerenex (ferric citrate coordination complex), an oral, ferric iron-based compound. Keryx has completed a U.S.-based Phase 3 clinical program for Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with chronic kidney disease (CKD) on dialysis, conducted pursuant to a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA). The Company’s New Drug Application (NDA) is currently under review by the FDA with an assigned Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014. The Company’s Marketing Authorization Application, seeking the approval of Zerenex as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD, has been submitted to the European Medicines Agency (EMA). The Company is also developing Zerenex in the U.S. for the management of elevated serum phosphorus and iron deficiency anemia in patients with Stage 3 to 5 non-dialysis dependent CKD. In addition, Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. has received marketing approval of ferric citrate (branded Riona®) in Japan for the improvement of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent CKD. Keryx is headquartered in New York City.
SOURCE: Keryx Pharmaceuticals
Post Views: 31
