Keryx Biopharmaceuticals, Inc. (KERX) continues to progress well with the development and commercialization of its sole pipeline candidate Zerenex.
Keryx is seeking marketing approval of Zerenex for the treatment of hyperphosphatemia (elevated serum phosphorus levels) in patients suffering from chronic kidney disease (:CKD) on dialysis.
Keryx received positive news when the U.S. Food and Drug Administration (:FDA) accepted its New Drug Application (:NDA) for Zerenex for hyperphosphatemia. The NDA was submitted for review in Aug 2013.
The NDA was filed based on data from a phase III registration program which Keryx conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA. The NDA also included safety and efficacy data from additional phase III studies conducted in Japan in CKD patients on dialysis.
We note that Keryx obtained a worldwide license (except for certain Asian Pacific countries) for Zerenex from Panion & BF Biotech, Inc. The rights for Zerenex in Japan have been sublicensed to Japan Tobacco Inc.
We remind investors that Keryx currently does not have any marketed drug in its portfolio. Hence, a marketing approval for Zerenex from the FDA and subsequent successful commercialization will be a major boost for Keryx.
Keryx is yet to submit Zerenex for review in the EU for the treatment of hyperphosphatemia.
Meanwhile, Keryx is also evaluating Zerenex in a phase II study for the management of elevated phosphorus and iron deficiency in anemic patients.
We note that Japan Tobacco has also filed a NDA with the Japanese Ministry of Health, Labour and Welfare for marketing approval of Zerenex in Japan for the treatment of hyperphosphatemia in patients with CKD.
Keryx Biopharmaceuticals currently carries a Zacks Rank #4 (Sell). Right now, stocks like Roche (RHHBY), Actelion (ALIOF), and Isis Pharmaceuticals, Inc. (ISIS) look attractive. All three carry a Zacks Rank#1 (Strong Buy).