BOSTON, Sept. 24, 2015 (GLOBE NEWSWIRE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that the European Commission has approved Fexeric® (ferric citrate coordination complex) for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD), including both dialysis and pre-dialysis patients. The European Commission considered ferric citrate coordination complex a New Active Substance, which provides 10 years of data and marketing exclusivity in Europe.
"We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease," said John Neylan, M.D., chief medical officer of Keryx. "Importantly, the EU product information contains data that is reflective of Fexeric's full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric's broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis."
"The differentiated profile of ferric citrate will be a new treatment option for our patients on dialysis and pre-dialysis," said Gilbert Deray, MD, Professor of Nephrology at Université Paris 6 Pierre et Marie Curie in Paris and Nephrologist and Head of the Department of Nephrology at Pitié-Salpêtrière University Hospital. "I look forward to using this medicine to control phosphorus levels when it becomes available in the E.U."
The European Commission's decision is based on evidence from approximately 1900 patients, including two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL (p<0.0001), the primary endpoint. These data were published in 2014 in the Journal of the American Society of Nephrology.
"EC approval is another validation by a global regulatory agency of the medicine's profile, and is another milestone in our efforts to expand the reach of ferric citrate to treat patients with renal disease," said Greg Madison, chief executive officer. "We continue to work with potential partners regarding commercialization in the EU, and expect to finalize our commercial strategy by the end of 2015."
The most commonly reported adverse reactions in dialysis-dependent CKD patients during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly reported adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%).
Ferric citrate coordination complex was approved under the brand name Auryxia™ by the U.S. Food and Drug Administration in September 2014, and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis. Keryx is conducting a Phase 3 study to potentially expand the label in the U.S. to treat iron deficiency anemia in pre-dialysis patients with chronic kidney disease.
ABOUT HYPERPHOSPHATEMIA IN CHRONIC KIDNEY DISEASE
In the five major markets in Europe (EU5), there are currently estimated to be approximately 1.3 million people diagnosed and treated with stages 3-5 CKD, and approximately 750,000 of these people are estimated to have hyperphosphatemia. In the U.S., Auryxia is currently indicated for 450,000 people with hyperphosphatemia and end stage renal disease (stage 5) who require dialysis.
Managing patients on dialysis is complex as many metabolic factors, such as iron and phosphorus, are out of balance. Phosphate retention and resulting hyperphosphatemia in dialysis patients are typically associated with increased risk for heart and bone disease, and death. The majority of dialysis patients require chronic treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. In addition, iron can be severely depleted in dialyzed patients, who are often treated with intravenous iron and/or anemia medications, such as erythropoiesis stimulating agents (ESAs), to help boost red blood cell production.
The Summary of Product Characteristics for Fexeric will be available at www.keryx.com through October 30, 2015, and will be available on the European Medicines Agency website at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003776/smops/Positive/human_smop_000859.jsp&mid=WC0b01ac058001d127&source=homeMedSearch&category=human.
IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA™ (ferric citrate)
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. Ciprofloxacin should be taken at least 2 hours before or after 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, with offices in New York and Boston, is focused on bringing innovative therapies to market for patients with renal disease. In December 2014, the Company launched its first FDA-approved product, Auryxia (ferric citrate) for the treatment of elevated serum phosphorus levels in patients with chronic kidney disease on dialysis, in the United States. 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. For more information about Keryx, please visit www.keryx.com.
Some of the statements included in this press release, particularly those regarding the approval and subsequent commercialization of Fexeric, 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 will able to identify and negotiate acceptable terms with a commercialization partner in the EU; whether we or a partner can successfully launch Fexeric in the EU; 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.
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