Keryx Biopharmaceuticals, Inc. (KERX) received good news when the European Medicines Agency (EMA.TO) determined that its Marketing Authorization Application (MAA) for lead candidate Zerenex was valid.
Keryx is seeking EU approval of Zerenex for the treatment of hyperphosphatemia in patients with chronic kidney disease (:CKD), including dialysis- and non-dialysis dependent CKD.
The validation of the MAA confirms that the data submitted for filing is sufficiently complete to begin the formal review process.
We remind investors that Zerenex is currently under review in the U.S. with an assigned Prescription Drug User Fee Act (:PDUFA) goal date of Jun 7, 2014.
In Jan 2014, Keryx’s Japanese partner, Japan Tobacco Inc. (:JT), received manufacturing and marketing approval for Zerenex as an oral treatment for the improvement of hyperphosphatemia in patients. Zerenex will be marketed in Japan by JT's subsidiary, Torii Pharmaceutical Co., Ltd, under the brand name Riona.
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 the EU and subsequent successful commercialization of the same 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 suffering from non-dialysis dependent CKD.
Keryx Biopharmaceuticals currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Actelion (ALIOF), Alexion Pharmaceuticals (ALXN) and Alkermes (ALKS). All three carry a Zacks Rank #1 (Strong Buy).