The US contract manufacturing organisation (CMO) initially halted production at the facility – one of the world’s largest sterile injectables plants – after US, European and French drug regulators voiced concerns about ‘quality management” mechanisms following a joint inspection.
The European Medicines Agency (EMA) subsequently recommended the recall of three cancer drugs made in Bedford – GSK’s Busilvex, Millennium Pharmaceuticals’ Velcade and Celgene’s Vidaza – and advised that a fourth – J&J’s Doxil – is only given to existing patients.
In December the EMA extended its action, recommending the recall of the cancer drug Vistide – made by Ben Venue on behalf for Gilead – and Pfizer’s antifungal Ecalta, which is also produced at the Ohio plant.
At the time Ben Venue said: “That routine preventive maintenance and requalification of some manufacturing equipment was overdue” and launched a site wide investigation of all four of the factories located at the site to determine what steps were required.
In its latest announcement - on December 23 - Ben Venue said it had extended the manufacturing shutdown to “permit the implementation of lasting corrective actions” and predicted that some production may restart in this quarter.
However, the firm also said the sites’ North facility will need major reconstruction work that could take nine months to complete and that no products made there will be available until the end of 2012.
Shortages
The extension is bad news for patients as it further limits supplies of vital treatments. It is also bad news for some of Ben Venues’ pharma industry clients as the firm is a key supplier.
Some like The Medicines Company, IDM Pharma, Alexion Europe and Astellas Pharma may not be impacted given that the drugs Ben Venue makes on their behalf are not the subject of regulatory action.
Others - like Sweden’s Meda - may also be relatively unaffected as - due to Bev Venue’s position as the world’s only supplier of the acute myeloid leukemia treatment Ceplene - mean the EMA has opted not to ask for a recall.
However, customers like J&J – for whom Ben Venue is the sole supplier of Doxil – will feel the impact of the continued shutdown more keenly and hence is likely to redouble efforts to find alternative CMOs.