Keryx Biopharmaceuticals ($KERX), which depleted supplies of its kidney drug when its CMO ran into production issues, has gotten CDMO Patheon approved by the FDA as a supplier and will soon have Auryxia in the hands of wholesalers.
The Boston-based drug company announced on Wednesday that a month after striking a long-term supply agreement with Patheon, the FDA had signed off on the CDMO to supply finished Auryxia. It said supplies have been rebuilt and should soon be back on the market.
“Our second contract manufacturer is successfully producing Auryxia,” CEO Greg Madison said in the company’s earnings release on Wednesday. “We are ready to promptly make Auryxia available to pharmacies.”
In its earnings, the company reported that despite the supply glitch, it had third-quarter Auryxia sales in the U.S. of $5.1 million compared to $3.2 million in the third quarter of 2015. It reported total revenue of $6.3 million, compared with $4.2 million during the same period in 2015.
The company indicated last summer that its unnamed CMO had been getting “variable yields” and the company had run out of finished product. It said it had already been working on finding a second supplier.