Japan Tobacco, Torii report positive top-line results from Phase III Zerenex study

The primary endpoint of efficacy has met non-inferiority to sevelamer hydrochloride in the top-line results, which evaluated the change of serum phosphorus from baseline.

JT and Torii are anticipating the submission of marketing application for ferric citrate in Japan in the fiscal year ending 31March 2013.

Keryx chief executive officer Ron Bentsur said, "We are also encouraged about our partner’s plans to file their marketing application in Japan within less than a year, similar to our expected timelines for the U.S. NDA and European MAA filings."

The open-label, randomized study is part of an ongoing Phase III program for ferric citrate in Japan for the treatment of hyperphosphatemia.

The study is evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia.