J&J says more Doxil shortages imminent, tied to Ben Venue problems

Fallout from the manufacturing mess pinpointed by the FDA at a Ben Venue Laboratories contract manufacturing plant two years ago continues to reverberate for Johnson & Johnson ($JNJ). Its Janssen unit yesterday notified doctors it expects further shortages of its cancer drug Doxil, for which Boehringer Ingelheim's Ben Venue is the sole supplier.

In a letter to physicians, the drugmaker said they can expect shortages of the ovarian cancer drug to hit in mid to late October, and it does not know when it will be able to get supplies back in their hands. Janssen is making progress toward getting an alternate supplier, but that will not keep supplies from being interrupted. The company suggested doctors could turn to its competitor, Sun Pharma, 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 Ben Venue to suspend operations in November 2011, creating a shortage of the widely-used Doxil. FDA Commissioner Margaret Hamburg turned to Sun Pharma to temporarily import Lipodox, a Doxil substitute that the FDA had not approved. Earlier this year, the FDA approved a version from Sun for the U.S. market to help ease the shortage.

J&J started looking for an alternate supplier, but also devised a multi-step process in which Boehringer did some of the Doxil production, but the drug was finished at another facility. The steps paid off at the time and shortages had abated. J&J earlier this month sued Ben Venue over the ongoing issue, seeking to get the German drugmaker in front of arbitrators. 

Ben Venue signed a consent decree in January covering the plant. Usually operations would be suspended until all problems are resolved, but because the contractor is the source of so many drugs, the FDA has allowed it to continue to manufacture about 100 essential drugs. Boehringer has said it intends to eventually stop contract work in Bedford 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