Alexion brought in a team of experts last year to help the company get on top of the manufacturing problems that led to an FDA warning letter for its plant in Rhode Island. But meanwhile, it has had problems with particulate tied to a contractor and today issued its third recall since August of orphan drug Soliris.
Alexion ($ALXN) is recalling another 9 lots of Soliris because of particulate, getting off the market the rest of the inventory made using a process that it identified as causing the problem. The Cheshire, CT-based drugmaker said that it found "visible proteinaceous particles" in a single lot during periodic testing but decided to recall 8 more lots because they were manufactured using the same process that the drugmaker now believes caused the problem.
Soliris is approved as a treatment for patients with either of two very rare conditions, paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome. It is a biologic that can cost patients up to $400,000 a year. Alexion said there have been no reports of patient issues but that the particulate could cause blood clots or an immune reaction.
Alexion also said it doesn't expect any interruption in supplying Soliris and that there should be no financial impact as a result of the recall. When it recalled product in November, the company said it would take a charge of $10 million to $25 million in the fourth quarter to cover the cost of replacing the affected inventory.
The company has struggled for awhile with its manufacturing. The FDA issued Alexion a warning letter in March 2013 for its Rhode Island manufacturing plant because of issues with bacterial contamination. The following month Alexion brought in a team of experts to help and has told analysts it believed it has already addressed the problems highlighted by the FDA.
- here's the release
- here's the FDA notice
Special Report: Top 20 orphan drugs by 2018 - Soliris