Keryx Biopharmaceuticals, Inc. KERX recently announced the publication of results from a phase III study on Auryxia in the online issue of the Journal of the American Society of Nephrology (JASN).
Shares of the company have significantly outperformed the Medical-Biomedical/Genetics sector in the last twelve months. The company’s shares gained 88.2% in the last twelve months, while the Zacks classified Medical-Biomed/Genetic Market declined at 10.4% in the same period.
The study evaluated ferric citrate (the compound name for Auryxia in additional indications) for iron deficiency anemia (IDA) in non-dialysis-dependent chronic kidney disease (NDD-CKD). We remind investors that Auryxia is approved in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis.
The results of the study show that ferric citrate achieved statistically significant results on the primary and all five pre-specified secondary endpoints for the treatment of IDA in adults with NDD-CKD versus placebo. Notably, patients enrolled in the trial did not sufficiently respond to or could not tolerate the previous treatment with oral iron.
In addition, ferric citrate showed a clinically meaningful 1 g/dL increase in hemoglobin levels for the majority (52.1% or 61 out of 117) of patients treated in the study at any point during the 16-week efficacy period. The drug started showing its effect on patients as early as one to two weeks after start of treatment.
The company recently submitted a supplemental new drug application (sNDA) with these data to the FDA. Upon approval, ferric citrate will be the first drug to be approved by the FDA for the treatment of iron deficiency anemia in patients with NDD-CKD.
Concurrent with second-quarter 2016 results, Keryx had announced a disruption in the supply of Auryxia as its contract manufacturer had issues related to the conversion of the API into the finished product. However, in Nov 2016, Keryx announced that the FDA has approved a second drug product manufacturer, Patheon Manufacturing Services, for supplying Auryxia as a finished product. Following the approval, the company rebuilt supply and expects to make Auryxia available to wholesalers.
Earlier in the week, Keryx announced that the FDA has approved Patheon’s manufacturing facility in France for the production of Auryxia. We note that the approval of this site provides Keryx with a third manufacturing location for finished drug. It also provides the company an extra source to help ensure supply of the drug without disruptions.
Concurrently, the company announced preliminary data for the fourth quarter of 2016. The company expects revenues of $9.5 million in the fourth quarter and $31.9 million in 2016. Prescription demand for Auryxia for the fourth quarter was approximately 8,700, which included approximately 4,500 prescriptions for the month of December, the first full month of sales post resupply of Auryxia.
We note that Auryxia faces stiff competition from the likes of Shire plc SHPG’s Fosrenol.
Keryx currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector are Kite Pharma, Inc. KITE and Anika Therapeutics, Inc. ANIK. While Anika sports a Zacks Rank #1 (Strong Buy), Kite Pharma has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Kite Pharma’s loss per share estimates narrowed from $5.50 to $5.48 for 2016 and from $7.00 to $6.85 for 2017 in the last 30 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 7.89%.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 36.4% in the past one year.
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