Positive news flowed in for Keryx Biopharmaceuticals, Inc . ( KERX ) when its Japanese partner, Japan Tobacco Inc. (JT), received manufacturing and marketing approval of Zerenex from the Japanese Ministry of Health, Labour and Welfare.
Zerenex will be marketed in Japan by JT's subsidiary, Torii Pharmaceutical Co., Ltd., under the brand name Riona.
We note that Zerenex is approved as an oral treatment for the improvement of hyperphosphatemia in patients with chronic kidney disease (CKD), including dialysis and non-dialysis dependent CKD.
As per the license agreement, Keryx is entitled to a milestone payment of $10 million. Keryx is also entitled to receive double-digit tiered royalties on net sales of Riona in Japan, as well as up to an additional $55 million upon the achievement of certain annual net sales milestones.
Meanwhile, Zerenex is currently under review in the U.S. with an assigned Prescription Drug User Fee Act (PDUFA) goal date of Jun 7, 2014. The company also plans to submit a Marketing Authorization Application (MAA) with the European Medicines Agency soon.
We remind investors that Keryx currently does not have any marketed drug in its portfolio. Hence, a marketing approval for Zerenex in the U.S. and subsequent successful commercialization will be a major boost for Keryx.
Meanwhile, Keryx is also evaluating Zerenex in a phase II study for the management of elevated phosphorus and iron deficiency in anemic patients in stage 3 to 5 non-dialysis dependent CKD.
Keryx Biopharmaceuticals currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Sangamo BioSciences ( SGMO ), Actelion ( ALIOF ) and Amicus Therapeutics ( FOLD ). While Sangamo BioSciences and Amicus carry a Zacks Rank #2 (Buy), Actelion is a Zacks Rank #1 (Strong Buy).ACTELION LTD (ALIOF): Get Free ReportAMICUS THERAPT (FOLD): Free Stock Analysis ReportKERYX BIOPHARMA (KERX): Free Stock Analysis ReportSANGAMO BIOSCI (SGMO): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment Research