Boehringer Ingelheim is to shut down its contract manufacturing unit Ben Venue Laboratories after a series of problems in recent years.
The German pharma company said production at the unit’s Bedford, Ohio site in the US will cease production by the end of year as it was not possible to return to a sustainable level of production.
This will result in the loss of about 1,100 jobs over a period of phased reduction that will stretch into 2014 and the company said it is “diligently working to minimise the potential impacts” on employees.
The closure will also affect the injectables manufactured at the site, which include cancer treatment Doxil, supplies of which are already facing shortages.
Boehringer said it was “exploring strategic options to try to continue the supply of these products to patients”.
The future of Ben Venue has been uncertain since August 2011 when Boehringer announced the site would no longer provide a contract manufacturing service for other companies.
This was followed in November 2011 by the news that Ben Venue had voluntarily suspended the manufacture and distribution of all products once it discovered routine preventive maintenance and re-qualification of equipment had not been carried out when it was supposed to.
A site-wide assessment was then carried out, with Ben Venue deciding to extended the suspension at the end of 2011. Inspections from both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both also uncovered problems with the site.
The suspension led to a shortage of Doxil, as well as the cancer drug methotrexate, forcing the FDA to approve new suppliers of the products and to rush through the approval of generic Doxil.
Limited manufacturing was resumed at the site at the end of 2012 after $300m was spent to upgrade its facilities, but further review has demonstrated that continuing to manufacture at the site’s current levels is not viable in the long run.
Boehringer estimates it would face cumulative operating losses of about $700m over the next five years if the site were to continue operating.
“The effort, magnitude of investment, and additional years required to remediate the facility before Ben Venue can return to sustainable production is not feasible,” said the company.