Keryx Biopharma (KERX) Says Second Contract Manufacturer for Auryxia Approved by FDA

November 9, 2016 10:43 AM EST
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Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced that the U.S. Food and Drug Administration (FDA) has approved its application for a second drug product contract manufacturer. Patheon Manufacturing Services LLC of Greenville, North Carolina, a leading global provider of pharmaceutical manufacturing services, is now an FDA approved drug product manufacturer of Auryxia®. With FDA approval of this manufacturer, the company has rebuilt supply and will promptly make Auryxia available to wholesalers.

“We are pleased with today’s approval, as it expands our manufacturing capabilities and capacity,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients.”

Mr. Madison continued, “We are looking forward to attending American Society of Nephrology’s Kidney Week, the global, premier kidney conference. The timing of this conference next week gives us the opportunity to communicate with health care professionals in attendance that Auryxia supply is restored and is once again available for their patients.”

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.



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