- Due to a production glitch experienced at the contract manufacturer level, Keryx Biopharmaceuticals has insufficient supplies of their kidney drug, Auryxia, the company said during a second quarter earnings call.
- The contract manufacturer has had problems converting active product ingredient to finished-form, film-coated tablets resulting in a variable product quality. While Keryx insists the safety profile of the drug is not affected, it is working with the manufacturer to renew supply.
- Since approval of the drug in 2014, Keryx has been looking for a secondary manufacturer. The biotech recently filed for approval of this manufacturer with the Food and Drug Administration and expects a decision in November.
Keryx Biopharmaceuticals told investors on Monday it expects to have insufficient supply of its only marketed product, saying there will likely be an interruption to supply. Keryx does not expect to be able to fulfill patient demand until the fourth quarter. The company noted that supply to its Japanese partner was not affected by the shortage.
The news sent shares of the company down almost 40% and pushed the Boston-based biotech to withdraw its guidance for the year.
"First and foremost, today we're thinking about the dialysis community and those patients currently taking Auryxia, who will be impacted by this unexpected supply interruption," said CEO Gregory Madison during a call on August 1. "As we work through this interruption, our field sales and medical organizations will stay highly engaged with the kidney dialysis community, which we believe will allow us to emerge from this interruption in the best possible position."
Madison noted during the call that the CMO notified the company last week of an issue and the pair agreed to halt production while the problem was being dealt with. "As a result of halting production, combined with the previous lower yields and increased demand, we've exhausted our reserves of finished drug tablets," he said.
The company would not give more color on what the nature of the production issue was, but said that next steps will be to "identify what the issue is and the root cause, fix that issue and get them back online as quickly as possible."
Keryx has been struggling to find a place in the market for the kidney drug, which competes with market-leader Renvela (sevelamer), made by Sanofi. The company reported second-quarter sales of $8.3 million for Auryxia. While up 44% year-over-year, sales of the drug are still well behind the $208 million brought in by Renvela during the three-month period.
Prior to the manufacturing problems, Keryx was pursuing a second indication for the drug in iron deficiency anemia in adult patients with non-dialysis-dependent chronic kidney disease.