Johnson & Johnson said a dispute with Boehringer Ingelheim GmbH over an agreement to produce the cancer drug Doxil may create a yearlong shortage of the medicine.
One of Boehringer’s U.S. units plans to shut down production of Doxil, used to treat ovarian cancer and other tumors, at year’s end even though it still owes J&J 67 batches, according to a filing by New Brunswick, New Jersey-based J&J in a Delaware court case. J&J has struggled to meet demand for the drug for the past two years because of disruptions at the Boehringer plant where it’s made.
Efforts for the past 20 months to boost Doxil supplies by enlisting other manufacturers have fallen short. Those companies won’t be able to win regulatory approval to make the drug until late 2014, lawyers for Johnson & Johnson’s Alza Corp. unit said in a brief filed yesterday as part of a lawsuit seeking to force Boehringer to arbitrate the dispute.
Another Doxil shortage “would again cause serious disruption and harm to hospitals, physicians and patients,” J&J said in the filing. Dwindling Doxil supplies also will cause “enormous reputational harm” to Johnson & Johnson (JNJ), the world’s biggest seller of health-care products, according to the filing.
“We can’t say in the U.S. when it will be available at this time,” Lisa Vaga, a J&J spokeswoman, said in a phone interview. “We’re working closely with health regulators to establish other avenues” to produce the drug, she said. “We’re doing everything we can.”
Marjorie Moeling, a spokeswoman for Boehringer’s Connecticut-based U.S. unit, said the company had “offered support” to J&J to help find alternative suppliers.
The company’s Ben Venue Laboratories unit, which has the Doxil supply contract, will continue to “work cooperatively with J&J to manufacture Doxil and to assist in J&J’s ongoing transition to alternate suppliers through the end of the current contract term,” Moeling said in an e-mailed statement.
Alza hired Boehringer as the “sole-source manufacturer” of Doxil in 1995 because Ben Venue Laboratories had special expertise in producing the drug, according to court filings.
Doxil production hit a snag in 2011 when Boehringer’s plant in Ohio was forced to shut down its manufacturing lines after the U.S. Food and Drug Administration questioned the quality of the facility’s products.
An FDA inspection of the Bedford, Ohio, plant found inadequate routine maintenance and microbial contamination with no clear source, the Cleveland Plain Dealer reported.
The FDA approved a generic version of the drug from India’s Sun Pharmaceutical Industries Ltd. (SUNP) in February because of the Doxil shortage. In a Sept. 25 letter to doctors, J&J warned that patients could face another shortage starting this month because of the dispute with Boehringer and reminded them the FDA has approved Sun Pharma’s generic version.
Boehringer officials alerted J&J in 2011 that they had decided to get out of the business of making drugs for other companies, according to the J&J court filing. Still, the Ingelheim, Germany-based company’s executives assured J&J they would meet their obligations under the Doxil contract, according to the brief.
The German drugmaker failed to meet Doxil production quotas this year and in 2012, J&J said in the filings. The plant only produced 10 batches of the 34 slated for delivery last year, J&J said.
The facility only made seven of 31 batches expected this year after being forced to shut down production lines twice because of mold problems and a roof leak, J&J officials added.
Officials from Boehringer informed J&J in July that they would be cutting off Doxil production by Dec. 31 and “would not make up any deficient production before winding down its manufacturing operations,” according to the filing.
Boehringer has “refused to provide assurances that it will continue to produce Doxil after Dec. 31 and until an arbitrator rules, and refused to proceed immediately to arbitration” as called for under the supply agreement, J&J said.
The Delaware case is Alza Corp. v. Boehringer Ingelheim USA Corp., 8877, Delaware Chancery Court (Wilmington).
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