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Genzyme Corp. is reporting that European regulators have given the company’s Allston plant the OK to continue to manufacture medications to be sold to European patients.
Inspectors from the European Medicines Agency (EMEA) visited the plant in August, following a six-week closure due to the discovery of a virus in the manufacturing process.
Genzyme officals say regulators confirmed that, based on this August inspection, the operations at the Allston facility are in “general compliance with the principles and guidelines of good manufacturing practice.” Based on this assessment, the inspectors have recommended to the EMEA the continued manufacture of all of the products currently produced in the facility.
Shortages of the two principal drugs made at the plant, Fabrazyme for Fabry disease and Cerezyme for Gaucher disease, continue following the closure of the plant and the subsequent disposal of partly finished batches of medicine, due to possible contamination by the virus. The virus does not harm humans but can make the drugs less effective.
Genzyme (Nasdaq: GENZ) officials announced in September its lower-end revenue expectations for 2009.
As a result of the drug shortages, the U.S. Food and Drug Administration has approved the Gaucher disease treatment developed by Israeli drug developer Protalix BioTherapeutics Inc. Likewise, Shire plc has sent its treatment for Gaucher disease, an alternative to Genzyme’s Cerezyme drug, to the FDA for approval as well.
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