Shire has been boosted by the news that European regulators have given the green light to one of the firm’s US manufacturing facilities to produce Vpriv, a move which will increase supplies of the Gaucher disease treatment.
Specifically, the European Medicines Agency’s Committee for Medicinal Products for Human Use has approved the production of Vpriv (velaglucerase alfa) at Shire’s $200 million new state-of-the-art plant in Lexington, Massachusetts. The European Commission is expected to give its stamp of approval “imminently”, and this means the Ireland-headquartered group now has two EMA-approved facilities in which to manufacture the therapy, the other being in Alewife, also in Massachusetts.
Shire noted that the approval is also “a critical first step in releasing further capacity” for the manufacturing of Replagal (agalsidase alfa) for Fabry disease at the Alewife facility. Both Vpriv and Replagal have benefited sales-wise from Sanofi-owned Genzyme Corp’s manufacturing problems with its rival therapies Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta).
