CHESHIRE, Conn.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the US Food and Drug Administration (FDA) has approved Alexion’s Rhode Island manufacturing facility (ARIMF) in Smithfield, Rhode Island as a second source of commercial supply for Soliris® (eculizumab). Earlier this year, Alexion reported that the European Medicines Agency had approved ARIMF as a second source of supply for Soliris in the European Union (EU). In addition to sourcing Soliris from ARIMF, the Company will maintain its agreement with its long-time contract manufacturer; either source can now meet all of the Company’s forecasted commercial and clinical needs for Soliris in the US and EU, which territories accounted for more than 90% of the Company’s 2009 revenues. Additionally, Alexion has applied for regulatory approvals for ARIMF in other countries where it has, or is establishing, commercial operations.
