J&J considers manufacturing workaround for Doxil
By jumping through some manufacturing hoops, Johnson & Johnson ($JNJ) hopes to ease the shortage of its cancer drug Doxil by this fall.
The drug was manufactured for J&J by Boehringer Ingelheim's Ben Venue Laboratories. But the Ben Venue Bedford, OH, plant that manufactures the product, and many others, closed in December as it tried to get on top of manufacturing problems cited by the FDA. The closure contributed to a shortage of the critical ovarian cancer treatment.
While Ben Venue does not expect to have its plant fully operational again until the end of the year, Johnson & Johnson spokeswoman Lisa Vaga told Bloomberg that it is working with the FDA and Ben Venue on a plan to get more product to market. The idea is to have Ben Venue formulate the drug and then ship it to another manufacturer for filling and manufacturing.
She told Bloomberg the company expects "health authority approval" around September and would get some limited supplies out shortly after. "This is a method for us to try to get Doxil back before the late 2012 time frame when the whole facility would be back up and running."
What supplies remain, Johnson & Johnson has been parceling out under guidelines of a special program and has had to turn away doctors with new patients needing the drug.
Trying to ease the shortage issue, the FDA in February gave temporary approval for Caraco Pharmaceutical Laboratories to import from India an unapproved drug that contains the same active ingredient as Doxil.
- get the Bloomberg story