A troubled US plant operated by Boehringer Ingelheim's Ben Venue subsidiary will close by the end of the year, raising the spectre of shortages of a key cancer drug.
The sterile injectables facility in Bedford, Ohio, cannot be put
back on a sustainable footing despite "the ongoing support of the US Food and
Drug Administration (FDA), the tremendous dedication of employees, and
significant investments in facility upgrades," said the company in a
The facility is
currently the only plant approved in the US to make Johnson & Johnson's
Doxil (doxorubicin), and compliance problems - including sterility failures -
have played havoc with J&J's ability to supply the drug over the last couple
Ahead of the closure announcement, J&J warned that it was
likely to experience "outages" in Doxil supply later this month, and was unable
to estimate when the drug would become available again. The company has filed a
lawsuit alleging breach of contract and trying to force Boehringer into
The decision puts 1,100 workers on notice of a
phased reduction in headcount - starting this month - as the activities at the
plant are wound down.
In a statement, Boehringer said the "magnitude of
continued investment and time required to overcome the systemic manufacturing
challenges is not viable," noting that $350 million has been invested in the
plant to date with losses of $700 million or more expected if it continues to
run Bedford over the next five years.
The closure will have a major
impact on J&J's efforts to develop an alternative manufacturing process for
Doxil. While the company has been working to transition production to another
contract manufacturer, an interim stage has seen it take bulk drug made at
Bedford for finishing at another supplier.
The FDA has approved imports
of a generic version of doxorubicin from Sun Pharmaceutical called Lipodox in
February under a priority review process designed to help alleviate drug
Meanwhile, the Bedford facility is not the only facility in
Boehringer's network to have attracted negative attention from the FDA. An
inspection of Boehringer's main site in Ingelheim prompted a letter from the
agency earlier this year citing significant violations of current good
manufacturing practice (cGMP) for the manufacture of active pharmaceutical
ingredients (APIs) and for finished drugs.
At the end of June, Wolfram
Carius, Boehringer's board member with responsibility for biopharmaceuticals and
production, stepped down to be replaced by former development head Wolfgang