J&J done with Boehringer plant after building a supply of Doxil

Johnson & Johnson's Janssen unit ended its manufacturing deal with Boehringer Ingelheim after building a supply of Doxil.--Courtesy of J&J

Boehringer Ingelheim closed its troubled sterile manufacturing site in Ohio at the end of last year, laying off 1,100 employees. But one facility didn't go completely dark. The plant had been the sole supplier of Johnson & Johnson's ($JNJ) popular ovarian cancer drug Doxil, and its Janssen unit worked out a deal to take over manufacturing of the bulk drug product for 6 months rather than risk it being unavailable. Now, with at least a 9-month supply of Doxil in hand, that arrangement is over.

Spokeswoman Linda Davis said in an email that Janssen's temporary lease of facilities at the Bedford, OH, plant ended June 30, after the company produced "sufficient supplies of Doxil to last more than 9 months." Davis said plans to establish two manufacturing sites for the drug, sold as Caelyx in some countries, are "progressing well." She said Janssen expects that the supplies made under the lease agreement with Boehringer's Ben Venue Laboratories "will allow us to bridge the transition to new long-term suppliers." One of the two plants the company has turned to is already making product for the international markets, "and we anticipate this product to be available for release later this year."

Ben Venue closed the Bedford, OH, plant in 2011 to make upgrades after FDA inspectors found problems throughout the facility, leaving Doxil supplies in doubt. Janssen planned to get new contractors approved to produce the drug but knew that would take time, given the complexity of the manufacturing process for the drug. In January 2013, Janssen worked out a deal in which the plant made bulk Doxil, and some other processes including sterile filtration and packaging were done at another facility. According to litigation between the companies, the plant managed to produce only 17 of 65 expected batches of the drug in 2012 and 2013. Then Ben Venue announced plans to close the plant.

Shortly before it was shuttered, Janssen announced it had negotiated a 6-month lease with Ben Venue to take over the Doxil-making portion of the plant. It sought FDA approval to bring in its own folks to handle the bulk product manufacturing and continue to hand off fill and finish to the contractor. The FDA agreed and has been approving lots manufactured under this "alternative manufacturing process," as they have been needed for distribution. Janssen informed providers on July 24 that a new lot had been approved and was available.

Now that Janssen is done there, Boehringer has someone else ready to determine the large facility's future. Jordan's Hikma said last week that it had agreed to take ownership of the plant, after striking a deal in May to buy the generic injectable drug unit of Boehringer Ingelheim's Ben Venue Laboratories group for up to $300 million.

- here's the latest Doxil lot release update (PDF)
- and the Hikma announcement