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.
The action seeks to force Boehringer Ingelheim into arbitration. "BI's breach of the agreement cannot be seriously disputed," J&J said in the lawsuit, according to Bloomberg, which was unable to get a comment from Boehringer.
Many drugmakers had supplies interrupted when Boehringer Ingelheim closed its Bedford, OH plant in 2011 because of serious quality issues, but it was a shortage of Johnson & Johnson's ovarian cancer drug Doxil that grabbed public attention. Because the facility was the sole supplier of Doxil, J&J and the FDA started jumping through hoops to get supplies of the essential treatment to patients when the problems hit. Now J&J wants something from Boehringer as compensation.
Johnson & Johnson and the FDA sprang into action in 2011 when J&J's popular chemo drug Doxil became hard to get because of problems with the contract manufacturer. But it also figured out a process by which it could have it manufactured at one plant and finished at another.
While the FDA has yet to give its final sign-off to this creative work-around, it has permitted the Johnson & Johnson subsidiary to release a lot at a time, the latest last week.
Boehringer Ingelheim's Ben Venue Laboratories plant in Bedford, OH, continues to struggle to make sterile products more than a year after it came under heightened FDA review for serious manufacturing problems.