Savient is off to a tough manufacturing start with Krystexxa, its gout treatment approved by the FDA last fall. Two contract manufacturers have reported batch failures; however, the company says it has a year's supply of the drug on hand.
The biopharma says it will repeat the manufacturing validation campaign at one of the CMOs--the Merck Biomanufacturing Network--to the tune of $9 million to $10 million over two years.
Merck and an unnamed contractor in Israel "have experienced some batch failures based on one manufacturing specification," Savient says. The biopharma has enlisted the help of a manufacturing consultancy, identified the root cause of the failures at both facilities, and begun remediation efforts to "minimize or eliminate" them.
The Israeli CMO recently produced two batches of pegloticase meeting all specs. At Merck, however, which Savient is qualifying as a secondary contractor, the initial manufacturing validation campaign was "unsuccessful," so it will repeat the process.
Savient has inventory at a third-party logistics warehouse in the U.S. as well as supplies of the finished drug that are packaged and labeled for distribution. Additional supplies of bulk product are scheduled for packaging and labeling.
The manufacturing setback is "not immediately a crisis" says analyst Gene Mack of Soleil, according to Reuters. "But it is something to watch."
Krystexxa, a PEGylated uric acid specific enzyme, gained FDA approval in September. The first patient received treatment last month and the company says it "continues to believe that it is on track" for the drug's promotional launch this quarter.
- here's the Savient statement
- see the Reuters story