SMITHFIELD – Alexion Pharmaceuticals Inc. said last week its manufacturing plant here 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.
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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 pre-approval 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.
Stephen P. Squinto, Alexion’s head of research and development, said the company was “pleased” that the European inspectors had given a positive recommendation to the Smithfield facility. “We now look forward to progressing our discussions and satisfying the requirements of the FDA, which would give us the additional option of using our Rhode Island facility as a second source to serve the U.S. market as well,” he said.
