The FDA has now signed off on Janssen's process of manufacturing bulk Doxil at an Ohio facility. It is part of an "alternative manufacturing process" in which the company hands off fill and finish of the drug to another manufacturer.
Johnson & Johnson's 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.
Janssen and Ben Venue officials have assured a federal court that any operations Janssen initiates at Ben Venue's now-closed Ohio 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 plant, which was the sole supplier of Doxil.
Boehringer Ingelheim stopped production at its Ben Venue Laboratories plant in Ohio this week, but now Janssen wants to lease the portion of the plant that made Janssen's ovarian cancer drug Doxil, which could relieve the shortage that has plagued the popular treatment since the FDA brought the hammer down on the plant two years ago.
Janssen Pharmaceuticals, which has struggled to maintain supplies of its cancer drug Doxil since supplier Ben Venue Laboratories ran into FDA issues, may have landed on a way to help keep supplies available. The Johnson & Johnson unit has an agreement to lease part of Ben Venue's Bedford, OH, plant and take on manufacturing itself.
With Johnson & Johnson's cancer treatment Doxil expected to run short till the end of 2014, India's Sun Pharmaceutical Industries stands to gain. To meet demand amid previous scarcity, the FDA allowed Sun's unapproved generic version of the drug to be imported into the U.S. Now, after a fast-track approval process, the drug has FDA's blessing, and Sun will have the market all to itself, at least for now.
After investing more than $350 million in upgrades, Boehringer Ingelheim has decided it is not worth continuing to pour money into its aging Ben Venue Laboratories plant in Bedford, OH, and will shut it down instead, canning the 1,100 people who work there.
The saga of the shortage of ovarian cancer drug Doxil has hit a new turning point, and not for the better. Johnson & Johnson has indicated it will have no supplies of the popular drug until at least the end of next year because its sole supplier is permanently closing the plant that makes it and it will be unable to get new suppliers approved for another 12 months or more.
The U.K. drug price watchdog today gave Johnson & Johnson's Caelyx the distinction of being one of only two drugs it believes should be funded by the National Health System to treat recurring ovarian cancer.
Johnson & Johnson's ($JNJ) Janssen unit, which has jumped through hoops to keep supplies of ovarian cancer drug Doxil in doctors' hands, is again being hamstrung by issues with its contract manufacturer, Ben Venue Laboratories.