By Peter Loftus
Johnson & Johnson (JNJ) said Thursday it would update a rationing program for the cancer drug Doxil to maximize the remaining supply and provide additional treatment cycles to patients already enrolled in the allocation program.
A shortage of Doxil, which treats ovarian and other cancers, emerged last year after J&J's contract manufacturer, Boehringer Ingelheim GmbH's Ben Venue Laboratories unit, experienced production problems. Ben Venue halted production at its Ohio plant in November to address regulatory concerns about contamination; it expects to resume production in late 2012.
No new Doxil has been manufactured, but J&J still has some unused supply to provide to patients under an allocation program created last year to manage the shortage. Some 3,300 patients are in the program.
Beginning Monday, J&J will ask doctors to reconfirm their current allocation for each patient by April 23. If J&J doesn't receive a patient's allocation confirmation or new-supply order by the April 23 deadline, the patient will be removed from the allocation program, J&J said in a notice posted on the Doxil website.
"We want to be sure that physicians reconfirm they continue to need their allocation," said Lisa Vaga, spokeswoman for J&J's Janssen unit, which markets Doxil.
In addition, doctors now have the option to re-enroll patients already in the program, regardless of whether they have completed their prior allocation or continue to receive therapy.
Doctors who determine a patient is receiving a clinical benefit from Doxil may request up to seven cycles of the drug to continue therapy. All requests will continue to be fulfilled on a first-come, first-served basis.
When J&J created the allocation program last year, it allotted up to seven cycles per patient on a first-come, first-served basis. J&J stopped accepting new enrollments after Ben Venue suspended production.
Hundreds of patients were once on a waiting list but J&J said in January it had enough supply to provide to all remaining patients on the list.
J&J, of New Brunswick, N.J., has been able to periodically identify additional supplies of Doxil for various reasons, including some patients having used less Doxil than the amount originally allotted. It is unclear how far the remaining supply will go because J&J doesn't know how much will be requested by doctors or used by patients, Vaga said.
J&J's U.S. Doxil sales plunged 50% to $140 million in 2011 due to the shortage.
In February, the U.S. Food & Drug Administration allowed the temporary importation of Sun Pharma's LipoDox as an alternative to Doxil.
J&J continues to try to restore a reliable Doxil supply, including by switching to another manufacturer.
More information about the latest Doxil supply update can be found at: http://www.doxil.com/doxil-supply-shortage.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; email@example.com