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Shire’s Vpriv manufacturing plant wins EMA approval

Regulator also confirms approval of 10 drugs made at Ben Venue

The European Medicines Agency (EMA) has said that Shire can use its Lexington, Massachusetts, manufacturing plant to produce Vpriv (velaglucerase alfa).

It is the second EMA approved facility to manufacture the drug, which is used to treat patients with type 1 Gaucher disease, a rare genetic condition that can cause skeletal disorders, enlarged spleen and liver, liver malfunction and anaemia.

Shire said the approval will 'significantly increase global supply of VPRIV and provides additional manufacturing flexibility'.

The company has invested over $200m in the plant in order to gain approval, increasing its capacity as well as making efficiency savings in water and energy.

There is also now the opportunity to increase production of Shire's treatment for Fabry's disease Replagal (agalsidase alfa) at the company's Cambridge, Massachusetts, facility, which had previously been the only plant to manufacture Vpriv.

“The EMA approval of VPRIV in this manufacturing plant, only three years after breaking ground, is a testament to the hard work and dedication of Shire employees, and represents crucial additional capacity for manufacturing our enzyme replacement therapies for Gaucher and Fabry patients,” said Bill Ciambrone, senior VP, technical operations, Shire HGT.

EMA confirms approval of 10 drugs made at Ben Venue Laboratories

The approval follows the EMA's decision to allow 10 out of 14 centrally authorised medicines manufactured at Ben Venue Laboratories in Ohio to remain available, although the facility must be removed as a manufacturing site from the marketing authorisation.

All manufacturing at the Ben Venue sire has been suspended due to a series of violations in standards, contributing to ongoing drug shortages in the US.

However, the EMA said Angiox, Busilvex, Vidaza, Vistide, Velcade, Ecalta diluent, Soliris, Cayston, Mepact and Torisel can all still be marketed in Europe as alternative suppliers and formulations are available.

A final decision was also made on Vibativ and Luminity, which have no alternative manufacturer or formulation, with the EMA recommending the suspension of the drugs' marketing authorisations until a suitable alternative manufacturing site is approved.

A review of two other centrally authorised medicines manufactured at this site, Caelyx and Ceplene, is still ongoing and is expected to be concluded in March, 2012.

24th February 2012

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