Press Release

Keryx Biopharmaceuticals Announces Presentation of Real World Dialysis Data of Auryxia® at ASN’s 2017 Kidney Week

NEW ORLEANS, Nov. 04, 2017 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a company focused on bringing innovative medicines to people with kidney disease, today presented new real world data from a large dialysis provider that showed Auryxia® (ferric citrate) tablets, when dosed as a phosphate binder, reduced erythropoiesis-stimulating agent (ESA) and intravenous iron (IV iron) use, while maintaining hemoglobin levels in patients on dialysis. These data were presented today in a poster at the American Society of Nephrology’s (ASN) 2017 Kidney Week taking place in New Orleans.

Auryxia is FDA-approved as a phosphate binder indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis. Keryx is seeking to expand the indication for Auryxia to include the treatment of iron deficiency anemia in patients with non-dialysis dependent chronic kidney disease (NDD-CKD). A supplemental new drug application is under review by the U.S. FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of November 6, 2017.

“Conclusions in this poster confirm the reductions in the use of IV iron and ESA observed in our pivotal Phase 3 study in patients with CKD on dialysis published in the July 2014 issue of the Journal of the American Society of Nephrology,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “These real world insights from a large number of patients improve the understanding of Auryxia and further demonstrate the ability of Auryxia to treat hyperphosphatemia and the value this medicine can bring to payers, physicians and patients.”

About the Real World Data
Poster presentation (#SA-PO825), titled: “The effect of ferric citrate on IV iron, ESA utilization and laboratory parameters in real-world dialysis practice.”

Data in this poster are from a retrospective study that evaluated health records and pharmacy claims for 2,395 adults on dialysis who initiated treatment with Auryxia as a phosphate binder during an 18-month period from January 2015 to July 2016. The study evaluated changes in laboratory parameters and change in IV iron and ESA utilization before and after Auryxia initiation. Outcomes were analyzed in three sequential follow-up treatment periods compared to baseline: follow-up 1: 0-91 days (n=926); follow-up 2: 92-182 days (n=419); and follow up 3: 183-274 days (n=200). Prior to Auryxia initiation, 91 percent of patients were previously on a phosphate binder and switched or added Auryxia to their treatment regimen. Results from the study confirmed the known profile of Auryxia to control serum phosphorus levels in dialysis patients and its ability to increase iron stores and reduce utilization of IV iron and ESAs. Real-world data in the poster include:

Mean Serum Phosphorus Levels: Mean serum phosphorus decreased from ~6.7 mg/dL at baseline to ~6.4 mg/dL in each of the follow up periods. At baseline, 25 percent of patients had serum phosphorus <5.5 mg/dL. After each of the follow-up periods at three, six and nine months, 34 percent (p<0.001), 40 percent (p<0.001), 36 percent (p=0.185) of patients treated with Auryxia achieved serum phosphorus <5.5 mg/dL, respectively. In addition, the overall phosphate binder pill burden decreased by >2 pills/day (p<0.001) in each follow-up treatment period.

Hemoglobin and Iron Parameters: Hemoglobin and iron parameter levels increased steadily from baseline to nine months (Table 1). Despite reductions in IV iron and ESA utilization, hemoglobin and iron parameters improved within 3 months of ferric citrate initiation in patients on dialysis. 

 
 Table 1: Change in Hemoglobin and Iron Parameters  
  Treatment Follow-up 1
0-91 days
(n=926)
Treatment Follow-up 2
92-182 days
 (n=419)
Treatment Follow-up 3
183-274 days
 (n=200)
Baseline mean hemoglobin (g/dL) 10.75 10.73 10.78
End of follow-up mean hemoglobin (g/dL) 10.87 10.90 11.11
p-values 0.009 0.011 0.001
Baseline mean TSAT (%) 30.0 29.8 29.0
End of follow-up mean TSAT (%) 33.4 34.4 36.4
p-values <0.001 <0.001 <0.001
Baseline mean ferritin (ng/dL) 644 638 620
End of follow-up mean ferritin (ng/dL) 720 770 863
p-values <0.001 <0.001 <0.001
       

IV Iron and ESA Utilization: With Auryxia treatment, overall IV iron and ESA use decreased in each follow-up period (Table 2). Additionally, for patients who received Auryxia for a full nine months (n=200) there was a steady decline in median IV iron and ESA dose during each of the follow-up periods. The median cumulative dose of IV iron declined by 20 percent, 50 percent and 60 percent at follow-up 1, follow-up 2 and follow-up 3, respectively; and the median ESA cumulative dose declined by 13 percent, 16 percent and 27 percent, respectively.

 
Table 2: Change in IV Iron and ESA Utilization
  Treatment Follow-up 1
0-91 days
(n=926)
Treatment Follow-up 2
92-182 days
 (n=419)
Treatment Follow-up 3
183-274 days
 (n=200)
% of patients with no IV Iron use
(at baseline)
22 21 16
% of patients with no IV Iron use 
(at end of follow-up period)
27 31 37
% of patients with no ESA use
(at baseline)
11 11 13
% of patients with no ESA use
(at end of follow-up period)
13 14 16
       

About Auryxia® (ferric citrate) tablets
Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.  

Use of ferric citrate in patients with IDA, NDD-CKD, as highlighted above, is investigational and has not been determined to be safe or efficacious. 

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA® (ferric citrate)

Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia®.

Iron Overload: Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.

Accidental Overdose of Iron: Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.

Patients with Gastrointestinal Bleeding or Inflammation: Safety has not been established for these patients.

Adverse Events: The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.

Drug Interactions: Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.

Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: whether we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia to the market; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. In September 2014, the U.S. Food and Drug Administration approved Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com.

KERYX BIOPHARMACEUTICALS CONTACTS:

Amy Sullivan
Senior Vice President, Corporate Affairs
T: 617.466.3519
amy.sullivan@keryx.com 

Lora Pike
Senior Director, Investor Relations & Corporate Communications
T: 617.466.3511
lora.pike@keryx.com 

Keryx Biopharmaceuticals, Inc.