European Authorities Approve New Manufacturing Facility for Shire's REPLAGAL

Shire plc SHPGY today announced that the European Medicines Agency has approved the purification of REPLAGAL drug substance at its new manufacturing facility in Lexington, MA, US. REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility. With this approval, the company now has two approved facilities - Alewife, which is located in Cambridge, MA, as well as the new Lexington facility - in which to purify REPLAGAL, thus providing increased manufacturing flexibility. The cell culture portion of the REPLAGAL manufacturing process will continue to be conducted at Alewife.