J&J's Doxil shortage to last until at least end of 2014

The saga of the shortage of ovarian cancer drug Doxil has hit a new turning point, and not for the better. Johnson & Johnson ($JNJ) 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.

 

J&J's Janssen unit recently notified doctors that shortages would begin this month. But according to Bloomberg, the company said in court filings last week that while it has been working for 20 months to get a new supplier for the drug, those contractors will be unable to make it through the FDA approval process before late 2014. The disclosures came in a lawsuit in which J&J accused Boehringer Ingelheim of breaching its contract to supply the drug.

A J&J spokeswoman told Bloomberg that the company is working with the FDA to find other ways to supply the drug but can't say when it will be available. "We're doing everything we can," Lisa Vaga told the news service. A spokeswoman for Boehringer responded to Bloomberg that the company had offered to help Johnson & Johnson find another supplier.


Steven Immergut, FDA assistant commissioner for media affairs, said in an email today that a generic of Doxil from Sun Pharmaceutical Industries is available. He said the agency does not expect it to be in short supply. The FDA put the Sun drug through an expedited approval this year to help boost supplies in the face of Doxil shortages. He said the agency is "evaluating whether Ben Venue's closing will implicate any drug shortages," and that the agency's drug shortage team is working through the government shutdown to prevent a situation that could result in a shortage.

Supply shortages of Doxil started in 2011 when the FDA found huge manufacturing and sanitary issues at the Ben Venue plant, leading it to intermittently halt production. According to the lawsuit, the company has produced only 17 of 65 expected batches of the drug in 2012 and 2013 and now says it will be unable to complete orders for 67 batches because it has decided to shut the Bedford plant.

Boehringer Ingelheim announced late last week that it just wasn't worth dumping any more money into the old sterile injectables facility. It will stop production by year-end and lay off 1,100 employees. The plant is operating under an FDA consent decree and the German company said it figured it would have $700 million in operating losses over the next 5 years if it continued to manufacture there. It said the "magnitude of continued investment and time required to overcome the systemic manufacturing challenges is not viable."

 

Much of the FDA is on furlough because of the government shutdown and the agency has not responded to a request for comment about what the FDA is doing about this and other potential shortages that will result from the plant closure.

 

The decision by Boehringer to close the plant is a boost to Sun Pharmaceutical Industries, which has the only approved generic, giving the Indian company the entire U.S. market until J&J gets new suppliers online. To help overcome shortages of the popular Doxil, the FDA last year also allowed Sun to temporarily import a version of the drug that it was selling in India but which had not been approved for use the U.S. Janssen, in its letter to doctors, suggested to doctors they might seek out the Sun Pharma generic.

http://www.fiercepharma.com/story/jjs-doxil-shortage-last-until-least-end-2014/2013-10-07