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 produce 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’s lawyers said in the filing. Dwindling Doxil supplies also will cause “enormous reputational harm” to Johnson & Johnson (JNJ:US), the world’s biggest seller of health-care products, according to the filing.
‘Can’t Say’“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.
Majorie Moeling, a spokeswoman for Boehringer’s Connecticut-based U.S. unit, said in an e-mail she couldn’t immediately comment on J&J’s allegations tied to the Doxil production agreement.
Alza Corp. hired Boehringer as the “sole-source manufacturer” of Doxil in 1995 because its Ben Venue Laboratories unit 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, according to the Cleveland Plain Dealer newspaper.
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 Doxil shortage starting this month because of the dispute with Boehringer and reminded them the FDA has approved Sun Pharma’s generic version.