Shire Announces Regulatory Filings in US and EU for New Manufacturing Facility; Approval Will Add Substantial Manufacturing Capacity for Rare Disease Products

Shire plc

today announced that it has submitted regulatory filings with both the European Medicines Agency (

) and the U.S. Food and Drug Administration (FDA) for the production of VPRIV® (velaglucerase alfa) in its state-of-the-art manufacturing facility at 400 Shire Way in Lexington, Massachusetts. Subject to regulatory approval, which is anticipated in early 2012, Shire expects the new plant to significantly increase manufacturing capacity and allow for increased global supply of VPRIV. These approvals will also make available further capacity for the manufacture of Replagal® (agalsidase alfa) at Shire's Alewife facility, where both VPRIV and Replagal are currently manufactured. "Shire remains committed to meeting the unique needs of patients living with rare diseases," said Bill Ciambrone, Senior Vice President, Technical Operations, Shire HGT. "Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for VPRIV less than two years after launch. Once approved, this new facility will give us greater flexibility to meet the global demand for VPRIV as well as some of our other products for rare diseases."