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Keryx (KERX) Announces Case Study Data Of Auryxia Presented At American Society of Nephrology’s Kidney Week



11/21/2016 10:47:26 AM

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- Majority of patients when started on Auryxia achieved target serum phosphorus levels within six months of treatment

CHICAGO, Nov. 18, 2016 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced case study data, which showed that Auryxia® (ferric citrate) lowered and maintained serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis. These data were presented in a poster presentation today at the American Society of Nephrology’s 2016 Kidney Week taking place in Chicago.

Auryxia (ferric citrate) is currently indicated for the control of serum phosphorus levels in patients with CKD on dialysis.

“Data from this poster at ASN provide the first real-world evidence of the effect of Auryxia in treating hyperphosphatemia in people on dialysis,” said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. “With Auryxia available again at pharmacies, we are pleased to be able to provide these data from the everyday practice setting that support Auryxia’s profile.”

About the Case Study Retrospective Data
Data from a retrospective chart review of 92 patients were collected by seven health care providers at multiple clinics across the U.S. Patients with CKD on dialysis who had been taking Auryxia for the control of serum phosphorus for a minimum of six months were selected to participate. The retrospective data demonstrate Auryxia’s effect in dialysis-dependent chronic kidney disease patients in routine clinical practice.

Of the 92 patient charts, 25 people were receiving peritoneal dialysis and 62 people were receiving in-center hemodialysis as part of routine clinical care. At the time of Auryxia treatment initiation, 21 patients (23%) were naïve to phosphate binders, while the remaining were treated with sevelamer (n = 37, 52%), calcium-based binders (n = 20, 28%), sevelamer + calcium (n = 10, 14%), or another binder (n = 4, 6%). Data collected included patients who took Auryxia for at least six months.

Case Study Data:
Target phosphate level: 22 percent of patients were within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL before taking one dose of Auryxia (i.e. baseline). At one and six months of treatment with Auryxia, 48 percent and 65 percent of patients, respectively, achieved serum phosphorus levels within the KDOQI guideline target range.

Mean serum phosphorus levels:  At baseline, patients had a mean serum phosphorus level of 6.55 mg/dL, which was lowered to 5.41 mg/dL after six months of treatment with Auryxia. The reduction in serum phosphorus levels were comparable in patients taking Auryxia who switched from sevelamer and/or calcium and in patients new to binders.

Daily tablets:  At baseline, patients were taking a mean of 11.7 tablets per day on their prior phosphate binder(s). Patients who stopped their prior phosphate binder(s) and switched to Auryxia had a mean tablet burden of 7.3 tablets per day at month six of treatment with Auryxia.

Iron biomarker levels (TSAT and Ferritin): At baseline, mean hemoglobin, ferritin, and transferrin saturation were 10.6 g/dL, 734 ng/mL, and 27.1 percent, respectively. These levels increased by month three and were maintained through month six. After six months of treatment with Auryxia, these levels were 11.1 g/dL, 947 ng/mL, and 37 percent, respectively.

Discontinuations: Five patients discontinued treatment after three months of treatment: three received kidney transplants, one discontinued dialysis and one was lost to follow-up.

About Auryxia
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 patients with CKD on dialysis. The U.S. approval of Auryxia was based on data from the company's Phase 3 registration program. 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.

Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.

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.

For Full Prescribing Information for Auryxia, please visit http://auryxia.com/important-safety-information/

Forward Looking Statements
Some of the statements included in this press release, particularly those regarding the commercialization and ongoing clinical development of Auryxia, 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; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in non-dialysis dependent (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; 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, with headquarters in Boston, is focused on bringing innovative medicines to market for people with renal disease. In December 2014, the company launched its first FDA-approved medicine, Auryxia® (ferric citrate) in the United States. In January 2014, ferric citrate was approved for use in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric® (ferric citrate coordination complex). For more information about Keryx, please visit www.keryx.com.

KERYX BIOPHARMACEUTICALS CONTACTS: Amy Sullivan Vice President, Strategic Operations and Corporate Affairs T: 617.466.3519 amy.sullivan@keryx.com Lora Pike Senior Director, Investor Relations T: 617.466.3511 lora.pike@keryx.com

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