Genzyme starts shipping Fabrazyme from Framingham facility
pharmafile | March 6, 2012 | News story | Manufacturing and Production |Â Â Fabrazyme, Framingham, GenzymeÂ
Sanofi subsidiary Genzyme has shipped the first supplies of Fabry disease treatment Fabrazyme produced at its new plant in Framingham, Massachusetts.
The development marks a milestone in Genzyme’s efforts to restore supplies of Fabrazyme (agalsidase beta) after contamination issues at its plant in Allston Landing, Massachusetts, in 2009 wreaked havoc with manufacturing capacity for the drug, along with other medicines such as Gaucher disease treatment Cerezyme (imiglucerase).
“Patients in the US are now able to return to full dosing in March,” said the company. In addition, all new patients in the US are eligible to begin Fabrazyme treatment at full dosing levels.
In Europe the process of moving the most severely affected patients to full dose of Fabrazyme is expected to begin shortly after, with efforts to supply patients in other areas of the world getting underway in the second quarter of 2012.
Fabry disease is an inherited is characterised by excessive accumulation of the lipid GL-3 in various organs and tissues.
Genzyme president and chief executive David Meeker said the ability to meet the needs of patients in the US “is an important first step in restoring unconstrained supply for all patients globally throughout the course of 2012.”
Sales of Fabrazyme in 2011 came in at €109 million, up around 9% on 2010 when the supply constraints were at their most severe. Interruptions in supply of Fabrazyme and Cerezyme have benefitted UK company Shire, which makes rival treatments for Fabry and Gaucher disease.
Late last month Shire got the go-ahead from the European Medicines Agency (EMA) for a US manufacturing plant that will make Gaucher disease drug Vpriv (velaglucerase alfa) and free up capacity for manufacturing Replagal (agalsidase alfa) for Fabry disease at another facility.
Phil Taylor
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