plant makes progress
with FDA and EU
SMITHFIELD – Alexion Pharmaceuticals Inc. said this month its local manufacturing plant is making progress in winning approval from regulators to manufacture its drug Soliris there.
Inspectors sent by the European Union recently recommended that the facility receive final approval, which Cheshire, Conn.-based Alexion expects to happen early next year.
The company also said it is planning to meet with U.S. Food and Drug Administration investigators, who have requested additional information about the plant and also want Alexion to conduct some test production runs as part of the preapproval process.
Until the plant is approved for full-scale production by regulators, Soliris is being produced under contract by the large Swiss chemicals and biotech company Lonza Group. The drug is a treatment for paroxysmal nocturnal hemoglobinuria, or PNH, a disorder that destroys red blood cells.
Alexion bought the 56,500-square-foot former Alpha-Beta Technology Inc. plant in Smithfield in July 2006, and began using it for the manufacturing research in late 2007. Alexion recently paid off the $44 million remaining on its mortgage for the factory.
The company has invested $140 million in the facility since purchasing it and currently employs about 100 workers there, a spokesman said. •