Keryx Biopharmaceuticals, Inc. (KERX) announced it has begun to ship Auryxia (ferric citrate) tablets to wholesalers in the U.S.
We note that Auryxia is approved for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.
The drug was approved by the FDA in Sep 2014 and the company had planned to launch the drug by the year-end. The approval was, however, accompanied by a few warnings.
Keryx has also filed for the drug in the EU as a treatment of hyperphosphatemia in patients suffering from CKD.
Meanwhile, Keryx is also working on the label expansion of Auryxia. The company has initiated a phase III study on Auryxia for the treatment of iron-deficiency anemia in patients with stages III to V CKD, who have previously not responded to oral iron therapy. The study will enroll 230 patients and will evaluate changes in hemoglobin levels as the primary endpoint.
Apart from Auryxia, Keryx currently has no other approved products. As a result, the company will have to be solely dependent on Auryxia for growth. However, quite a few limitations and warnings have restricted its sales potential substantially. We expect investor focus to remain on the drug, going forward.
We remind investors that Auryxia is already approved in Japan under the trade name Riona for the treatment of patients suffering from all stages of CKD.
Keryx Biopharmaceuticals currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the healthcare sector include Allergan Inc. (AGN), Shire (SHPG) and Sucampo Pharmaceuticals (SCMP). While Sucampo carries a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy).
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