J&J builds 9-month supply of Doxil with creative problem solving

Johnson & Johnson is building a 9-month supply of Doxil.--Courtesy of J&J

A Johnson & Johnson ($JNJ) exercise in creative problem solving has paid off for doctors and patients who rely on its ovarian cancer drug Doxil, availability of which has been uncertain for years. Its Janssen unit has accumulated a significant supply after assuming manufacturing at Boehringer Ingelheim plant that otherwise was closed down at the end of the year.

Spokeswoman Linda Davis said in an email that Janssen's temporary lease of facilities at the Bedford, OH, plant was not extended after lapsing at the end of June, but that the company had manufactured "sufficient supplies of Doxil to last more than 9 months." Doxil is sold as Caelyx in some countries. The product will be available on a lot-by-lot basis, assuming the FDA approves them, which it so far has done for the product manufactured in Janssen's alternative process. In fact, Janssen informed providers Thursday that a new lot had been approved and was available for distribution. Meanwhile, Davis said, plans to establish two manufacturing sites to manufacture the drug were "progressing well."

Branded Doxil, although off patent, has remained a popular drug. But shortages arose in 2011 when Ben Venue, a division of Germany's Boehringer Ingelheim, had to close the Bedford, OH, plant to make upgrades after FDA inspectors noted huge issues with it. Janssen's long-term plan was to get new contractors approved to produce the drug. But it needed a short-term solution.

In January 2013, Janssen worked out a deal where the plant made bulk Doxil, and some other processes including sterile filtration and packaging were done at another facility. But the situation got even more complex when Boehringer Ingelheim determined last year that the operating losses it faced at the Bedford plant were more than it was prepared to bear and decided to close the plant at the end of the year and lay off its 1,100 employees.

Janssen, which was in litigation with Boehringer for failing to live up to its supply promises, negotiated a 6-month lease with Ben Venue, and took 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 as they have been needed for distribution.

Now that Janssen is done there, Boehringer has someone else ready to determine the large facility's future. Yesterday, Jordan's Hikma said 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. It said it would move some of the new equipment in the facility to its other sterile injectable drug manufacturing facilities, as it ponders whether to reactivate any of the four plants at the site. It said one of the biggest assets of the deal with the R&D facilities and employees in Bedford, which will help it more quickly get the products it bought from Boehringer back into the market.

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