Keryx Focuses on Kidney Drug Auryxia Despite Generic Threat

We issued an updated research report on Keryx Biopharmaceuticals, Inc. KERX on Sep 26, 2017.

Notably, the company’s only marketed product, Auryxia (ferric citrate) is approved in the United States for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis.

In the second quarter of 2017, net sales of Auryxia in the United States were $14.1 million, up 71% following strong prescription growth. In fact, a total of 21,100 prescriptions were written in the reported quarter, up 61% year over year. Also, Auryxia was added to Medicare Part D drug list at two of the largest Medicare Part D insurance providers, which will give the drug unrestricted access to approximately 95% of phosphate binder patients.

Currently, Keryx is working on expanding Auryxia's label to include the treatment of iron deficiency anemia (IDA) in adults with stage III–V non-dialysis dependent (NDD) CKD. In March 2017, the FDA accepted the company’s supplemental New Drug Application (sNDA) for Auryxia for review and gave a Prescription Drug User Fee Act (PDUFA) target action date of Nov 6, 2017. A potential approval is expected to significantly boost sales of Auryxia.

Meanwhile, the company is looking for potential partners to commercialize the drug in the EU. Ferric citrate (the compound name for Auryxia for additional indications) has been considered as a new active substance by the European Commission. This provides it with 10 years of data and marketing exclusivity in the region.

However, Auryxia faces stiff competition in the United States from existing players. Apart from over-the-counter drugs like some calcium carbonate and metal-based products including aluminum and magnesium, Sanofi’s SNY specialty medicines arm, Genzyme Renagel and Renvela, Shire plc’s SHPG Fosrenol, and Fresenius Medical Care’s FMS PhosLo and Velphoro are already available in the market.

Since Auryxia is in early stages of commercialization, we believe the company may face a tough time gaining share.

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