Boehringer Ingelheim, the German pharmaceutical company and contract manufacturer, will close its entire Ben Venue Laboratories operation in Bedford, Ohio, by the end of 2013. In August, the firm said it would close part of the facility and cut 400 jobs. The full closure will affect 1,100 employees.
One of Ben Venue’s major products is Johnson & Johnson’s anticancer drug Doxil, a nanoscale liposomal form of doxorubicin. In late September, J&J warned about likely supply shortages this fall; the shortages may now extend into 2014. The Food & Drug Administration did approve a generic version of Doxil from India’s Sun Pharmaceutical Industries in February.
Boehringer has struggled to keep the Ohio site open after a series of drug quality problems and has been operating since January under a consent decree with FDA. “Despite the ongoing support of the U.S. Food & Drug Administration, the tremendous dedication of employees, and significant investments in facility upgrades, the company cannot return to sustainable production,” Boehringer says.
Given the facility’s age and condition, further improvements would require significant additional investment beyond the $350 million already spent to “overcome the systemic manufacturing challenges.” Keeping the site open also would cost the firm about $700 million over the next five years.
Boehringer says it has notified FDA of its decision and is working to minimize the impact on patients. In particular, the company is looking at ways to continue supplying sterile injectable drugs now made at the plant.