Janssen and Ben Venue officials have said that multiple steps must be taken before the Johnson & Johnson ($JNJ) subsidiary can take over a portion of the now-closed Ben Venue plant and restart manufacturing of Doxil there. The companies this week moved forward apace, assuring a federal court that any operations Janssen initiates at the facility will comply with provisions of a consent decree that Ben Venue signed last year. The move came the same day that production officially ceased at the Bedford, OH, plant, which was the sole supplier of Doxil.
Janssen spokeswoman Lisa Vaga said Ben Venue Labs and ALZA, an affiliate of Janssen, submitted a notice to the U.S. District Court for the Northern District of Ohio on Tuesday stating ALZA's plans to lease a portion of the Ben Venue facility to oversee the manufacture of bulk Doxil/Caelyx. The notice acknowledges that its operations where the drug is manufactured will be subject to the FDA consent decree approved by the court last year. Vaga also said that ALZA has registered with the FDA to manufacture at the plant.
Citing confidentiality agreements, Vaga said she couldn't say what the FDA thinks about the arrangement or whether Janssen intends to manufacture the drug itself or bring in a contractor. "We continue our conversations with the U.S. FDA regarding both this short-term plan and other long-term options for manufacturing," Vaga said.
J&J and Boehringer Ingelheim, which owns Ben Venue, last month struck a deal for Janssen to lease the portion of the plant that made the popular ovarian cancer drug. If finalized and approved by the FDA, it could ease the shortage that has plagued the treatment since the FDA brought the hammer down on the plant more than two years ago.
Boehringer Ingelheim spokeswoman Marjorie Moeling, who confirmed the agreement, said that Boehringer will not be involved in the production, and that production at the plant ended Tuesday as planned. An unspecified number of employees needed to handle the final "wind-down" of the plant are still there, but the rest of the plant's 1,100 employees have been let go. She said Ben Venue would not be involved if Doxil production is restarted but that some former employees might be offered jobs by Janssen or its contractors.
The Ben Venue plant was the sole supplier of Doxil, and when it ran into FDA problems in 2011, it left Janssen scrambling for ways to keep the medication available. Ben Venue signed a consent decree last year and has made about $350 million in improvements, but this fall it decided it wasn't worth keeping the plant operational. Janssen, which had already sued Ben Venue over their supply contract, told the court the shutdown would further complicate availability. The litigation claims Ben Venue produced only 17 of 65 expected batches of the drug in 2012 and 2013.
- here's Janssen's last update on Doxil supplies (PDF)