update
Alexion to close Rhode Island Soliris plant and cut jobs
Alexion, which had 3,100 employees at the end of last year, announced the closure and job cut plan in a US Securities and Exchange Commission (SEC) filing yesterday, explaining the move is designed to save $250m (€208m) a year.
A spokeswoman for the firm told us "The decision to close the site was driven by our need to optimize our multi-product manufacturing network strategy in line with our objective to have flexible, multi-product facilities that combine Alexion and contract manufacturing capacity. Since the Rhode Island facility is not optimally suited to accommodate our future pipeline, including ALXN1210, we have made the decision to close the site."
Alexion has approximately 250 employees in Rhode Island. The spokeswoman said: "We recognize that these changes are difficult for our employees, and we will continue to work with Governor Raimondo and will support employees during this transition. Employees are eligible for severance as well as access to Career Transition Services and the Employee Assistance Program (EAP).
"We will be focusing manufacturing at other company manufacturing facilities as well as through our manufacturing partners" she said.
Alexion will also relocate its headquarters to a site in Boston, Massachusetts next year and convert its current base in New Haven, Connecticut into an R&D centre.
Facility history
The Smithfield, Rhode Island manufacturing facility makes the active pharmaceutical ingredient (API) for the immunosuppressant Soliris (eculizumab) as well as the finished product. It has been the subject of US Food and Drug Administration (FDA) criticism in recent years.
In 2013 the agency issued Alexion with a warning letter after inspectors spotted a number of deviations from current good manufacturing practices (cGMP), including the detection of “residues in already-cleaned equipment.”
The US agency reinspected the facility in 2014 issuing Alexion with a second Form 483.
And in August last year Alexion was issued with another Form 483 detailing issues related to “completion and closure of certain investigations, validation of surface sampling methods and monitoring of water systems.”