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Keryx Focuses on Kidney Drug Auryxia Despite Generic Threat
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We issued an updated research report on Keryx Biopharmaceuticals, Inc. 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 - Free Report) specialty medicines arm, Genzyme Renagel and Renvela, Shire plc’s Fosrenol, and Fresenius Medical Care’s (FMS - Free Report) 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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Keryx Focuses on Kidney Drug Auryxia Despite Generic Threat
We issued an updated research report on Keryx Biopharmaceuticals, Inc. 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 - Free Report) specialty medicines arm, Genzyme Renagel and Renvela, Shire plc’s Fosrenol, and Fresenius Medical Care’s (FMS - Free Report) 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.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>