J&J warns doctors Doxil shortage will hit next month

Supplies of ovarian cancer drug interrupted by issues at Ben Venue plant
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Johnson & Johnson's ($JNJ) Janssen unit, which has jumped through hoops to keep supplies of ovarian cancer drug Doxil in doctors' hands, is again being hamstrung by issues with its contract manufacturer, Ben Venue Laboratories.

In a letter to physicians Wednesday, the drugmaker said they can expect shortages of Doxil to hit in mid to late October, and the company does not know when the issue will be resolved. Janssen is making progress on getting an alternate supplier, but that will not keep supplies from being interrupted. The company suggested doctors could turn to its competitor, Sun Pharmaceutical, which is now producing an FDA-approved generic version of the drug. That news pushed Sun's shares to new highs on Indian stock exchanges, according to Reuters, which says Sun has already captured 50% of the market since supply issues arose.

Manufacturing and sterility problems at the Bedford, OH, plant forced Boehringer Ingelheim's Ben Venue to suspend operations in November 2011, interrupting supplies of many meds and creating a shortage of the widely-used Doxil. FDA Commissioner Margaret Hamburg turned to Sun Pharma to temporarily import an unapproved version of the drug then worked with the Indian company to get a version approved for the U.S. market. 

J&J started looking for an alternate supplier when the problems arose, but also devised a multi-step process in which the Ohio plant did some of the Doxil production, but the drug was finished at another facility. The steps paid off at the time, and shortages appeared to be resolved before this week's announcement. J&J earlier this month sued Ben Venue over these ongoing issues, seeking to get the German drugmaker in front of arbitrators.

Boehringer has said it intends to eventually stop contract work at the Bedford plant, which has been operating under a consent decree since January, and just manufacture its own sterile drugs there. It is closing the oldest part of the facility and will lay off up to 400 workers by the end of the year.

- here's the Janssen letter (PDF)
- get more from Reuters

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FDA brings Sun's Doxil copy online to fix shortage 
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