Dive Brief:
- The U.S. Food and Drug Administration has approved Keryx Biopharmaceuticals' application for a second drug product contract manufacturer, the Boston-based company said Nov. 9.
- Patheon Manufacturing Services LLC of Greenville, North Carolina, a global provider of pharmaceutical manufacturing services, is now an FDA-approved drug product manufacturer of Auryxia (ferric citrate), Keryx said.
- FDA's approval of Patheon means that Keryx has rebuilt supply and will promptly make its kidney drug available to wholesalers, Keryx said. The drug is indicated in the U.S. for controlling serum phosphorus levels in patients with chronic kidney disease who are on dialysis.
Dive Insight:
During a second-quarter earnings call in August, Keryx said it had insufficient supplies of Auryxia because of a production glitch at the contract manufacturer level. At the time, Keryx noted that, since Auryxia's approval in September 2014, the company had been looking for a secondary manufacturer, had filed for approval of a secondary manufacturer with FDA, and anticipated a decision in November.
Keryx President and CEO Greg Madison said Nov. 9 that things are now on track. "We are pleased with today’s approval, as it expands our manufacturing capabilities and capacity," he said. "Getting a second drug product manufacturer approved was an important step to ensuring long-term supply of Auryxia is consistently available to patients."
Moreover, Madison said the timing of the American Society of Nephrology’s annual Kidney Week, being held Nov. 15-20, "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."
Keryx's stock rose on its news of bringing Patheon onboard to address supply issues, but the company also reported a higher-than-expected third-quarter loss of 39 cents, not 22 cents, per share. Revenues exceeded expectations at $6.3 million, above the consensus estimate of $5.8 million, analysts at Zacks Equity Research said, and Auryxia's net U.S. product sales were $5.1 million, up about 58% from the year-ago quarter.
Some analysts cautioned that how providers respond to Auryxia's disruption over the longer term remains an unknown.