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Keryx Biopharmaceuticals Announces Commencement Of Phase 3 Program Of Ferric Citrate (Zerenex™)

May 18, 2017

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), announced that its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), JT's pharmaceutical business subsidiary, has commenced the Phase 3 clinical program of ferric citrate in Japan for the treatment of patients with hyperphosphatemia. Under the license agreement with JT/Torii, within 30 days, Keryx will receive a non-refundable milestone payment of $5 million from JT/Torii for the achievement of this milestone. Zerenex™ (ferric citrate), a ferric iron-based phosphate binder, is also in Phase 3 clinical development in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis.

Ron Bentsur, Chief Executive Officer of Keryx, stated, "We congratulate our partner, JT/Torii, on the initiation of the Phase 3 program in Japan and are excited by their progress. We believe that this serves to further validate the commercial potential for Zerenex worldwide."

Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.

Sublicense Agreement with Japan Tobacco & Torii Pharmaceutical

In September 2007, Keryx sublicensed to JT and Torii the exclusive rights for the development and commercialization of its hyperphosphatemia drug, Zerenex (ferric citrate), in Japan. The licensing arrangement calls for JT and Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of specified milestones, of which $28 million has been received by Keryx to date. In addition, upon commercialization, JT and Torii will make royalty payments to Keryx on net sales of the drug in Japan. JT and Torii are responsible for all development and commercialization costs in Japan.

Source: Keryx Biopharmaceuticals, Inc