NEW YORK, Dec. 2, 2014 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on bringing innovative therapies to market for patients with renal disease, today announced the publication of Auryxia phase 2 clinical trial results in non-dialysis dependent chronic kidney disease (NDD-CKD) patients in the American Journal of Kidney Diseases (AJKD). Based on the results of this study, in September 2014, the Company initiated a Phase 3 pivotal program of Auryxia as a treatment for iron-deficiency anemia in patients with Stages 3-5 NDD-CKD.
The study's Co-Chairmen were Geoffrey Block, MD, Director of Clinical Research at Denver Nephrology; Glenn Chertow, MD, Professor of Medicine and Chief, Division of Nephrology at Stanford University School of Medicine; and Steven Fishbane, MD, Division Chief, Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center.
Dr. Block commented, "Iron deficiency anemia is very common in chronic kidney disease stages 3 to 5, with more than 1.5 million Americans estimated to be impacted by this condition. Currently, there are no good treatment options for patients as conventional oral iron formulations are poorly absorbed and not well tolerated. The results of this study support further evaluation of Auryxia for the treatment of iron deficiency anemia in this patient population."
About Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anemia
It is estimated that approximately 10% to 15% of the U.S. adult population is affected by chronic kidney disease (CKD), a condition generally characterized by greater than 50% reduction of normal kidney function. Iron deficiency anemia, which develops early in the course of CKD and worsens with disease progression, is extremely prevalent in the NDD-CKD population and is associated with fatigue, lethargy, decreased quality of life and is also believed to be associated with cardiovascular complications, hospitalizations, and increased mortality. Based on data contained in a 2009 publication in the Journal of the American Society of Nephrology, it is estimated that over 1.5 million adults with NDD-CKD in the U.S. alone are also afflicted with iron deficiency anemia. To combat this anemia, iron replacement therapy is essential to increase iron stores, such as ferritin and TSAT levels, and raise hemoglobin levels.
About Auryxia™ (ferric citrate)
Auryxia (ferric citrate) is an oral, absorbed, iron-based phosphate binder. In the United States, Auryxia was approved by the Food and Drug Administration (FDA) on September 5, 2014, for the control of serum phosphorous levels patients with chronic kidney disease (CKD) on dialysis. Auryxia will be marketed in the U.S. by Keryx Biopharmaceuticals, Inc. Keryx plans to make Auryxia available to dialysis patients in the U.S. this year.
In January 2014, ferric citrate was approved for the treatment of patients with all stages of CKD in Japan, where it is being marketed as Riona® by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd.
In March 2014, Keryx filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), seeking the approval of ferric citrate as a treatment of hyperphosphatemia in patients with CKD, including dialysis and non-dialysis dependent patients, and that application is currently under review.
For more information about Auryxia, visit www.Auryxia.com. For Full Prescribing Information for Auryxia, please visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
Auryxia (ferric citrate) Important Safety Information
Contraindication: Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia (ferric citrate).
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.
For Full Prescribing Information for Auryxia, please visit http://keryx.com/wp-content/uploads/Auryxia_PI_Keryx_112014.pdf.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, headquartered in New York, is focused on bringing innovative therapies to market for patients with renal disease. The Company's FDA-approved product, Auryxia, is indicated in the United States for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx plans to commercially launch Auryxia in the U.S. at year end. For more information regarding Keryx, please visit www.keryx.com
Cautionary Statement
Some of the statements included in this press release, particularly those relating to the results of clinical trials or the commercialization and subsequent clinical development of Auryxia (ferric citrate), 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: the risk that we may not be successful in the development of ferric citrate for the treatment of iron deficiency anemia in non-dialysis chronic kidney disease patients; whether Auryxia will be successfully launched and marketed in the U.S.; whether Riona® will be successfully marketed by our Japanese partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co., Ltd; the risk that the EMA may not concur with our interpretation of our Phase 3 study results, supportive data, conduct of the studies, or any other part of our MAA submission and could ultimately deny approval of the MAA; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, 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. 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, or on the websites of the American Journal of Kidney Diseases the National Kidney Foundation, or the Journal of the American Society of Nephrology, is not incorporated by reference into this press release and is included for reference purposes only.