Shire’s Vpriv plant wins EU approval
pharmafile | February 28, 2012 | News story | Manufacturing and Production |Â Â EMA, Shire, VprivÂ
Shire has been told by the European Medicines Agency that it can make use of a manufacturing facility in Lexington, Massachusetts, to make Gaucher disease drug Vpriv, helping to boost supplies of the drug.
This is the second facility to be approved by the EMA to make Vpriv (velaglucerase alfa) after its Alewife facility in Cambridge, Massachusetts, which is also used to make its Fabry disease drug Replagal (agalsidase alfa).
Shire said the additional capacity will allow it to “significantly increase global supply of Vpriv” as well as providing ‘additional manufacturing flexibility’. One key effect will be to free up manufacturing capacity for Replagal at Alewife.
The Lexington facility was set up with an investment of around $200 million and is also awaiting approval by the FDA following a preliminary inspection.
Shire said the new facility increases bioreactor capacity from 1,000 to 8,000L, adding that it is the first commercially licensed facility in the world to make use of single-use bioreactor and disposable technology throughout cell culture processing, to reduce manufacturing risk.
Shire’s Vpriv and Replagal therapies have benefited from ongoing shortages in rival Gaucher and Fabry disease drugs from Sanofi’s Genzyme subsidiary, caused by manufacturing issues at its Allston Landing plant.
Given the shortages the FDA allowed Vpriv and Replagal to be distributed to patients, even before they had been approved in the US. Vpriv was cleared by the FDA in February 2010 and Replagal is currently under review with a decision expected in May 2012. Last year, sales of Replagal grew 35%, to $475 million, while Vpriv advanced 27% to $805 million.
“We welcome the news that Shire’s new manufacturing facility in Lexington has received EMA approval for the production of Vpriv,” commented Tanya Collin-Histed of the European Gaucher Alliance.
“This provides patients with greater comfort over the maintenance of supply of enzyme therapies for the treatment of Gaucher disease.”
Phil Taylor
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