The FDA has issued a warning letter for the plant where Alexion Pharmaceuticals ($ALXN) manufactures its pricey rare-disease drug Soliris. The letter has yet to make it to the FDA's website, but the company got ahead of the news by reporting to the SEC that the warning was delivered yesterday.
Alexion says the agency was not satisfied with how it investigated "bacterial contamination of certain batches," as well as other cGMP issues. The inspection last August also found some repeat problems from a visit the year before. The "FDA expressed a general concern that we have not implemented a robust quality system," the company said.
The company says in an 8-K filing that it is hard at work fixing the problems and does not expect the back and forth with the FDA to interrupt supplies of Soliris, a biologic that can cost patients up to $400,000 a year. Soliris is approved to treat a rare kidney disorder, atypical hemolytic uremic syndrome, and the blood disorder paroxysmal nocturnal hemoglobinuria. "We continue to manufacture products, including Soliris, in this facility," the 8-K reports.
Alexion wanted to make sure the market understands it has a backup plan if manufacturing at the Rhode Island facility is halted. It has one contract manufacturer already approved and expects FDA approval of a second contractor in the fourth quarter. In the meantime, it estimates that it has 4,000 patient-years of supply in its inventory, although it doesn't say how long that might last. It intends to notify international regulators that "it is possible that the letter may impact our ability to supply Soliris manufactured at our Rhode Island facility outside the United States."
According to a note to investors from Leerink Swann Research, Lonza is the backup supplier producing Soliris commercially, "and management states that Lonza is able to supply the entire market." While this is a serious issue, LSR said it believe it was manageable and should not have a "material impact" on sales. "ALXN had the foresight to build duplicate manufacturing capacities," it said.
- here's the SEC filing
- and Alexion's release
Editor's note: The story was updated to include comments from Leerink Swann Research.