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Press Release

Keryx Biopharmaceuticals Announces Presentations of Data at the American Society of Nephrology Kidney Week 2016 Annual Meeting


Posted on: 14 Oct 16

BOSTON, Oct. 14, 2016 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that researchers will present new data from a pivotal Phase 3 study of ferric citrate for the treatment of iron deficiency anemia (IDA) in adults with non-dialysis dependent chronic kidney disease (CKD). Researchers will also present post-marketing analysis detailing real-world use of Auryxia® (ferric citrate) as a treatment for hyperphosphatemia in people with CKD on dialysis. The data will be presented in five poster presentations at the 2016 American Society of Nephrology (ASN) Annual Meeting being held November 15 - 20, 2016, in Chicago.

Auryxia® is currently indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. Abstracts of the five presentations are accessible on ASN’s website at https://www.asn-online.org/education/kidneyweek/archives/.

Four abstracts related to IDA will be presented together in a poster session on Thursday, November 17, 2016 from 10:00 a.m. to 12:00 p.m. Central Time (CST).

Abstract Number: 2200
Presenter: Steven Fishbane, M.D.
Title: Effects of ferric citrate in adults with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Phase 3 Clinical Trial

Abstract Number: 3705
Presenter: Glenn Chertow, M.D.
Title: Hemoglobin response to ferric citrate in subjects with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Data from a Phase 3 clinical trial

Abstract Number: 3429
Presenter: Geoffrey Block, M.D.
Title: Effects of ferric citrate on parameters of mineral and bone metabolism in patients with non-dialysis dependent chronic kidney disease treated for iron deficiency anemia

Abstract Number: 3937
Presenter: Pablo Pergola, M.D.
Title: Predictors of hemoglobin response to ferric citrate in patients with non-dialysis dependent chronic kidney disease and iron deficiency anemia

One abstract related to the treatment of hyperphosphatemia with Auryxia in the dialysis setting will be presented in a poster presentation on Friday, November 18, 2016 from 10:00 a.m. to 12:00 p.m. CST.

Abstract Number: 2598
Presenter: Pablo Pergola, M.D.
Title: The effect of ferric citrate (Auryxia) on serum phosphate control in dialysis patients: Real-world data

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 as well as the expected impact of the supply interruption of Auryxia and the expected timing of when we will have a sufficient supply of Auryxia to make it available to patients again following the supply interruption, 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: our ability to quickly and successfully identify and resolve the production-related issue; our ability to quickly and successfully identify and engage secondary suppliers of finished drug product; our ability to receive FDA approval of any secondary suppliers of finished drug product; 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; whether we will able to identify and negotiate acceptable terms with a commercialization partner in the E.U.; whether we or a partner can successfully launch Fexeric® in the E.U.; whether Riona will be successfully marketed in Japan by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; 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

GlobeNewswire
globenewswire.com

Last updated on: 17/10/2016

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