J&J moves forward with its plan to make Doxil in part of the closed Ben Venue plant

Boehringer Ingelheim stopped production at its long-troubled Ben Venue Laboratories plant in Ohio this week, but it may not be the end of the line for the facility. Janssen Products has an agreement with the German company to lease the portion of the plant that made Janssen's ovarian cancer drug Doxil. If the deal gets finalized and approved by the FDA, it could provide a solution to the shortage that has plagued the popular treatment since the FDA brought the hammer down on the plant two years ago.

"We have reached an initial agreement to lease some parts of the plant and steps are being taken to transition manufacturing," Lisa Vaga, a spokeswoman for Janssen, a subsidiary of Johnson & Johnson ($JNJ), said recently. "Although we've reached an initial agreement to lease the portions of Ben Venue's facility that produce Doxil, there are multiple steps required to transition manufacturing and any plans are subject to FDA and health authority approvals." 

On Tuesday, Vaga said that Ben Venue Labs and ALZA, an affiliate of Janssen, had submitted a notice to the U.S. District Court for the Northern District of Ohio 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 an FDA consent decree approved by the court last year. Vaga also said that ALZA has registered with the FDA to manufacture at the plant. 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.

In a statement to FiercePharmaManufacturing, Boehringer Ingelheim spokeswoman Marjorie Moeling said her company hopes the "agreement will help support a continuation of patient supply as Janssen continues to transition to ... new suppliers." She said Ben Venue employees will not be involved in the manufacture of bulk Doxil in 2014. "All manufacturing will be conducted by Janssen or its contractors. Certain former Ben Venue employees may be offered employment with Janssen or its contractors."

Manufacturing and sterility problems at Ben Venue forced the contractor to suspend operations in November 2011 and later to sign a consent decree with the FDA. Its importance to the U.S. supply chain was marked by the fact that the FDA allowed it to continue to manufacture about 100 essential drugs while remediation took place. But in October, the company threw in the towel, saying that while it had already invested $350 million in upgrades to the facility, it projected it would suffer $700 million in operating losses over the next 5 years to keep it open. It started laying off employees and put the plant up for sale. Moeling said this week that production was complete there, but that since "the wind-down work requires support, some employees will remain until that work is completed."

The Ben Venue plant was the sole supplier of Doxil, and so the decision to close further complicated J&J's efforts to keep the drug available. Litigation J&J filed against Ben Venue claimed the plant had produced only 17 of 65 expected batches of the drug in 2012 and 2013. It said the plant halted production of the drug twice because of mold issues and because a roof was leaking.

Vaga cited confidentiality agreements for not providing more details about the agreement and what J&J's plans are for manufacturing there. She reiterated what the company has been saying for months: Janssen has been in discussions with Ben Venue about various alternatives to ensure continued supplies into 2014 for Doxil, an older but very popular drug. It has said its talks with Ben Venue are one of several options being explored with the FDA to keep Doxil accessible in the short and long term. It has also been working to get new suppliers approved to make the drug, but that has yet to happen.

- here's Janssen's last update on Doxil supplies (PDF)