Manufacturing problems at a Boehringer Ingelheim plant did a double whammy on Johnson & Johnson's ($JNJ) cancer drug, Doxil. It forced J&J to ration the drug to patients, current and future. It also interrupted clinical trials testing new drugs with or against J&J's ovarian cancer treatment, putting pipelines in jeopardy.
J&J now says it appears Boehringer Ingelheim will return to production by year's end, allowing it to release some supplies of Doxil for a trial by Endocyte ($ECYT) that will test an experimental drug in conjunction with Doxil, The Wall Street Journal reports. Endocyte says with what J&J will provide and what it has on hand, it can sign up patients without interruption. J&J says VentiRx Pharmaceuticals is getting a supply to test its experimental cancer drug, VTX-2337.
The shortage arose after manufacturing problems at Boehringer's Ben Venue Laboratories plant in Ohio halted production. J&J worked with the FDA to release Ben Venue's stock of Doxil, and the FDA allowed temporary imports of Sun Pharma's Lipodox, a similar drug not yet approved in the U.S.
Initially, Johnson & Johnson restricted Doxil to current patients. In May, doctors were given some for new patients after prior requests from doctors changed.
J&J tells the Journal that it continues to work on a plan to get more supply out before the end of the year. In April, it said it would try to split production at the plant from fill and finish work elsewhere as a workaround to boost supplies.
- read the Wall Street Journal story
J&J opens up Doxil rationing on 'limited' new supply
J&J looks for workaround to ease Doxil shortage
FDA brings Sun's Doxil copy online to fix shortage