Thursday, October 10, 2013

Boehringer Unit That Makes J&J's Doxil And Other Drugs Will Shut Down

A Boehringer Ingelheim GmbH unit that has been beset by manufacturing difficulties said it plans to shut down starting this month, eliminating 1,100 jobs and exacerbating shortages of cancer and other drugs.

The Ben Venue Laboratories unit, which makes drugs for other companies and for its own sale, has struggled over the past few years with production problems that prompted tight monitoring by the U.S. Food and Drug Administration and disrupted the supply of cancer drugs like Doxil. J&J , which sells Doxil made for it by Ben Venue, said last week that it expected more shortages of the drug because of "external difficulties."

A J&J spokeswoman said the company is talking with Ben Venue about ways to ensure continued supplies of Doxil into 2014. The spokeswoman said that Ben Venue was just "one of several options we continue to explore in order to keep this therapy accessible for patients, in both the short- and long-term."

Ben Venue, based in Bedford, Ohio, said Thursday that the company has spent more than $350 million to date to upgrade its production, but still projected operating losses over the next five years of about $700 million if it kept trying to meet good manufacturing standards. Instead, the company said it would cease production by the end of this year and end packaging, labeling and all other activities next year.

"The effort, magnitude of investment, and additional years required to remediate the facility before Ben Venue can return to sustainable production is not feasible," the company said. "Ben Venue understands the importance of the drugs the company produces, and will work to help ensure that these critical medicines continue to reach the patients who need them."

Other drugs that Ben Venue makes include cancer treatments adriamycin and methotrexate, the anesthetics midazolam and ketamine, and the antipsychotic haloperidol.

The decision to end all operations appears to mark a chance in course from June, when Ben Venue said it was curbing production but still keeping around 800 employees.

In addition to making drugs under contract for other companies, Ben Venue produces its own line of sterile injectable drugs. Boehringer Ingelheim is "exploring strategic options to try to continue the supply of these products to patients," according to the Ben Venue statement.

Ben Venue said it would help assist in J&J's transition to other suppliers. Doxil is prescribed to treat ovarian, multiple myeloma and other cancers.

Last month, J&J sued Ben Venue and Boehringer Ingelheim in Delaware Chancery Court alleging breach of contract and seeking arbitration to resolve the dispute between the companies. A Ben Venue spokeswoman declined to comment about the lawsuit.

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