|Johnson & Johnson's Janssen unit released a new lot of its cancer drug Doxil.--Courtesy of J&J
Johnson & Johnson's ($JNJ) Janssen, which has struggled to maintain ready supplies of its ovarian cancer treatment Doxil, has released a new lot of the popular drug. The injectable cancer med was produced through an "alternative manufacturing approach," in which the now-closed Ben Venue plant in Ohio made the bulk product and another manufacturer finished it off.
In a letter to healthcare professionals today, the drugmaker said that while the FDA has yet to sign off on the its two-facility process, it did clear the lot of Doxil for distribution. Janssen said that the batch got the full Janssen review to ensure that it hit all of the drugmaker's quality and safety standards.
Shortages of Doxil first arose in 2011 when Ben Venue, a division of Germany's Boehringer Ingelheim, had to close the Bedford plant to make upgrades after FDA inspectors found 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, Janssen spokeswoman Lisa Vaga explained in an interview today. But the situation got even more complex when Boehringer Ingelheim determined last year that the operating losses it faced at the plant were just too much to bear and decided to close the plant at the end of the year.
Janssen again found itself getting creative and in December it signed a 6-month lease with Ben Venue, taking over the Doxil-making portion of the plant. It sought FDA approval to allow it step in and handle the bulk product manufacturing and continue to hand off fill and finish to the contractor. Vaga said Monday, "the FDA has accepted our interim control plans at the Bedford facility to handle the bulk manufacturing for the period of the lease agreement. Under the lease, we plan to continue to release Doxil through FDA regulatory discretion as supplies become available, using this alternate manufacturing approach." That is the near-term solution, Vaga said, and in the long term, Janssen is making progress on agreements with other manufacturers.
While Janssen's doggedness has been good for patients, it creates some uncertainties for India's Sun Pharmaceuticals. The FDA last year gave a quick approval to Sun's generic version of Doxil for sale in the U.S. in an effort to help relieve the supply questions. When Boehringer Ingelheim announced last October it was giving up on the Ben Venue plant, it appeared Sun would have all that business to itself. But Sun's stock took a hit when it was announced Janssen might take over where Ben Venue left off. Now that Janssen has secured that, Sun will continue to compete in the U.S. against Janssen's well-established drug.