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Keryx's Zerenex demonstrates noninferiority to Genzyme's Renagel in late-stage trial in Japan

Monday, April 23 2012 | Comments
Evidence Grade 0 What's This?
Keryx Biopharmaceuticals Inc.'s Zerenex (ferric citrate), an iron-based phosphate binder, met the primary endpoint of a Phase III trial in Japan as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who were undergoing hemodialysis.

Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd., which are Keryx's development partners in that region, conducted the open-label, randomized trial to evaluate the efficacy and safety of the compound, known in Japan as JTT-751, as compared with Genzyme Corp.'s Renagel (sevelamer hydrochloride) during 12 weeks of treatment.

Top-line results showed that the drug met the primary efficacy endpoint, demonstrating noninferiority relative to Renagel in the change from baseline in serum phosphorus levels.

In addition, there were no clinically meaningful safety or tolerability findings observed during the treatment period.

Japan Tobacco and Torii plan to submit a marketing application for the drug in Japan during the fiscal year that ends March 31, 2013.

Ron Bentsur, Keryx's chief executive officer, noted that this timeline is similar to Keryx's anticipated timeline for filing for approval of Zerenex in the United States and Europe.

Keryx licensed the rights to Zerenex in all regions, except for certain Asian Pacific countries, from Taiwan-based Panion & BF Biotech Inc. in 2006. In 2007, Keryx sublicensed the rights to develop and commercialize the drug in Japan to Japan Tobacco and Torii.

Chugai Pharmaceutical Co. Ltd.
markets Renagel in Japan.

Shares of Keryx closed at $1.75, up $0.39, or 28.7 percent, in heavy volume on the Nasdaq.

This information concerns a use that has not been approved by the Food and Drug Administration.

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