The FDA told Alexion ($ALXN) in a warning letter late last month that its quality system at a plant in Rhode Island was not "robust" enough given that inspectors found some of the same problems observed in earlier visits. The agency offered up its standard suggestion that Alexion hire experts who could help it get on top of the problems there. That is what Alexion has done.
In a conference call with analysts last week, the maker of pricey rare-disease drug Soliris said it had hired consultants that would help design a quality system that would exceed the standards of regulators worldwide. Co-founder Steve Squinto said the consultants had already helped Alexion get on top of the bacterial contamination issues the FDA was upset about at the Rhode Island plant. According to a transcript of the call from Seeking Alpha, Squinto said the hired guns were doing a gap analysis across the entire Alexion system to help it "raise the bar in all aspects of our manufacturing quality operations." The company also said that Squinto will be responsible to see that it happens in his new position as executive VP and chief global operations officer.
Squinto said the company believed it has already addressed many of the problems the FDA noted by changing the way it cleans and stores bioreactor equipment. It also re-engineered a drain that it thinks was the source of bacterial contamination observed by the FDA. The warning letter took note of residue on already-cleaned equipment. Inspectors also said the facility had experienced elevated counts of Bacillus thuringiensis in early stage processes. Soliris is a sterile biologic drug approved to treat a rare kidney disorder, atypical hemolytic uremic syndrome, and the blood disorder paroxysmal nocturnal hemoglobinuria.
The company has made sure the market knows that no finished product was contaminated and that there will be no shortage of the drug, which can run up to $400,000 a year for some patients. Alexion continues to manufacture Soliris at its Rhode Island plant and has approval for one contract manufacturer to produce the drug as part of its plan to manufacture the drug globally. It expects approval of a second contractor by the fourth quarter.
- here's the Seeking Alpha earnings call transcript