ARTICLE | Company News

Keryx's ferric citrate gets Japanese approval

January 18, 2014 2:17 AM UTC

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) said Japan's Ministry of Health, Labor and Welfare (MHLW) approved Riona ferric citrate to treat hyperphosphatemia in dialysis-dependent and non-dialysis-dependent patients with chronic kidney disease (CKD). The approval triggered a $10 million milestone payment to Keryx from Japanese partner Japan Tobacco Inc. (Tokyo:2914). Keryx said it expects Japan Tobacco to launch Riona in Japan next quarter. Japan Tobacco has exclusive, Japanese rights to the oral ferric iron-based phosphate binder from Keryx under a 2007 deal.

Ferric citrate is also under FDA review as Zerenex, with a June 7 PDUFA date. Keryx plans to submit an MAA to EMA this quarter. The company has worldwide rights to the product, including Japan but excluding the rest of the Asia-Pacific region, from Panion & BF Biotech Inc. (Taipei, Taiwan). ...