Shire gets green light for second Replagal facility
pharmafile | June 28, 2011 | News story | Manufacturing and Production |Â Â Replagal, Shire, Vpriv, pharma manufacturing newsÂ
The European Medicines Agency has approved a second manufacturing facility in the USA for Shire’s Fabry disease treatment Replagal.
Shire’s new plant in Lexington, Massachusetts, has been cleared to purify the active ingredient in Replagal – agalsidase alfa – adding to the firm’s existing purification capacity at its Alewife facility in nearby Cambridge.
The Fabry disease drug will be the first product to be made at the new plant, using bulk material produced in Alewife’s cell culture suites. From next year it will also be producing Shire’s new Gaucher disease product Vpriv (velaglucerase alfa), if all goes according to plan.
Replagal has been experiencing buoyant growth in the wake of manufacturing problems at drugmaker Genzyme, which makes rival product Fabrazyme (agalsidase beta).
Restricted supplies of Fabrazyme following a contamination incident at Genzyme’s Allston Landing facility helped Replagal post an 81% increase in sales last year to $351 million. While Genzyme is close to getting its manufacturing operations back in order, the firm was forced to discard one lot of Fabrazyme earlier this year which held back its plans to restore full supply.
Genzyme’s production problems have also wreaked havoc with its Gaucher drug Cerezyme (imiglucerase), accelerating US approval of Vpriv and allowing Shire’s drug to grab a healthy slice of the market despite being on the market for just 14 months.
“We are pleased that we were able to accelerate the construction and approval of our new manufacturing facility in order to provide rapid access to important therapies for patients in need,” commented Bill Ciambrone, senior vice president of technical operations at Shire HGT.
“This new facility allows greater flexibility to meet global demand for our products, including Replagal,” he added.
The 200,000 sq.ft. Lexington facility cost an estimated $250 million to set up and is claimed to be the largest bioprocessing facility in the world using disposable manufacturing equipment.
Phil Taylor
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