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Genzyme Reports Progress Related to Allston Plant

26 Jun 2009 - Genzyme Corporation provided an update on its progress toward restoring production at its Allston Landing manufacturing facility and in implementing temporary supply management measures. The company announced last week that it had interrupted production of Cerezyme® (imiglucerase for injection) and Fabrazyme® (agalsidase beta) at the plant to sanitize the facility, after identifying a virus in a bioreactor used for Cerezyme production. The virus impairs the viability of cells used in the manufacturing process and is not known to cause infection in humans.
 
Following a collaborative interaction with FDA and EMEA, Genzyme has begun shipping product from finished lots of Cerezyme held in inventory, after PCR testing detected no evidence of Vesivirus 2117. Shipments of Fabrazyme were not put on hold.
 
"We continue to make strong progress toward resolving this situation as quickly as possible, thanks to a broad group of employees across the company who have been working around the clock,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer. "We are confident that the Allston plant will be back online later next month, that we will be able to minimize the impact of constrained supply, and that the measures we are implementing will prevent this issue from occurring again. The support we have received from regulatory authorities, patients, suppliers, and from our industry peers who have shared their experiences and offered expertise and resources, has been heartening.”