1,100 jobs to go as Ben Venue confirms closure of Bedford unit
pharmafile | October 7, 2013 | News story | Manufacturing and Production, Sales and Marketing |Â Â Ben Venue, Boehringer, FDAÂ
Boehringer Ingelheim is calling time on its troubled facility in Ohio operated by Ben Venue Laboratories and says it will close down production by the end of the year.
The Bedford plant has been operating under a Food and Drug Administration (FDA) consent decree since January after a series of Good Manufacturing Practice (GMP) violations, including sterility failures for injectable products and inadequate hygiene standards.
Boehringer said in a statement towards the end of last week that it had already spent some $350 million on remediation at the plant – which makes sterile injectables sold under the Bedford Laboratories brand as well as producing drugs for other companies – and estimates it would have to absorb operating losses of $700 million or more in order to bring it up to code.
The closure will result in the loss of around 1,100 jobs starting this month and continuing throughout 2014, said Ben Venue in a statement.
“Although interim controls implemented to assure product quality have been effective to date, in the long term, they are not sustainable,” the firm conceded, adding that it has already notified the FDA of its decision to close.
Doxil shortages looming?
The closure of the plant has been rumoured for a while, with reports circulating last month that a shutdown may cause a shortage of critical medicines, notably Johnson & Johnson’s cancer drug Doxil (liposomal doxorubicin) which has already been badly affected by a temporary shutdown in 2011.
Ben Venue has been the only US supplier of Doxil for more than a decade, but the quality violations at the Bedford facility prompted the FDA to approve a generic version from Sun Pharmaceutical earlier this year in order to help alleviate the resulting shortages.
In January, J&J said it was hopeful that supplies of Doxil would get back to normal after securing approval for a new production route with the first stages of production carried out at Bedford and the latter fill-and-finish stages transferred to another contract manufacturing organisation (CMO).
The ultimate aim was to transition Doxil production to other CMOs as Ben Venue has made no secret of its intention to exit the CMO market and concentrate on supplying its own products. Now, the transition stage seems to be in jeopardy and J&J has warned that it may start to experience outages of Doxil in ‘mid-to-late October’.
“We currently cannot estimate when Doxil will be available again,” said the firm in a letter to physicians on 25 September.
J&J recently launched a lawsuit against Boehringer and Ben Venue, arguing that the companies were in breach of contract for failing to maintain Doxil supplies and attempting to force Boehringer into arbitration on the matter.
At the time of writing J&J has not commented publicly on the impact of the latest Ben Venue announcement.
Phil Taylor
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