In a statement the US biotechnology firm said the FDA “intends to take enforcement action to ensure that products manufactured at the plant are made in compliance with good manufacturing practice regulations.”
The action, Genzyme explained, will most likely involve a third party review of manufacturing operations at the facility and will require that the firm “make payments to the government.”
The FDA’s decision follows almost a year of problems at facility in Allston, Massachusetts, where Genzyme produces its key biotech products Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta).
The firm said that production of the two drugs is likely to continue while the enforcement action is in place “based on its initial communication with the agency and the medical need for patients.”
Genzyme also expects shipments of Myozyme and Thyrogen, which are filled and finished at Allston, to continue while the FDA measures are in place
The firm said that it will work “restore the agency’s confidence in its ability to operate the Allston plant at the highest standards.”
However, it appears that investors do not share Genzyme’s optimism. The firm’s share price fell 6 percent to $55.33 in trading on March 24 Wednesday when the news was announced.
The response is understandable. At present, Cerezyme leads the Gaucher’s disease market which, although small, generates almost 30 per cent of Genzyme’s annual revenues, primarily as a result of the drug’s $200,000 a year price tag.
Last year when manufacture of the drug was halted following the detection of viral contamination, rivals Protalix and Shire were granted special dispensation to supply unapproved competitor drugs to make up for the shortfall.
Any repeat of such disruption would further threaten Genzyme’s market dominance.