Johnson and Johnson announced that they do not expect more Doxil (doxorubicin HCl liposome injection) to be available until sometime late in 2012, as a result of the continued suspension of manufacturing at the third-party site responsible for producing the drug, which is used to treat patients with recurrent ovarian cancer or relapsed or refractory multiple myeloma.
Johnson and Johnson made the announcement when they received an update from Ben Venue Laboratories, the third-party manufacturer of Doxil. In a statement, the company reported that it was extending the voluntary suspension of manufacturing at its Bedford, Ohio, facility in order to "fully understand the potential impact and implement any appropriate corrective actions that may be needed as quickly as possible to ensure that healthcare providers and patients have access to the medicines they need." The suspension began in November, after an internal review indicated that routine preventative maintenance was "overdue."
Because of this suspension, Ben Venue estimated that Doxil would not be available until sometime late in 2012. In the meantime, Johnson and Johnson is exploring using an "alternate supplier" in order to meet the demand for the drug, according to a statement from Rob Bazemore, president of Janssen Products, LP, the pharmaceutical company of Johnson and Johnson responsible for Doxil.
"Restoring a reliable supply of Doxil continues to be our most urgent priority, and we have been seeking the input of those who might be able to expedite alternate and innovative solutions," Bazemore said in the statement. "While these discussions are ongoing and we don't have news to share today, we hope to provide an update in early 2012."
Earlier this month, Johnson and Johnson announced that a limited supply of Doxil would become available through the Doxil Creating Awareness and Reinforcing Education Support (CARES) Physician Access Program for physicians who are starting patients with recurrent ovarian cancer on Doxil. However, in the statement provided by Bazemore, all of that supply of Doxil has since been allocated.
"Until Doxil is produced again, we regret we are no longer accepting new additions to the Doxil CARES Physician Access Program wait list," Bazemore said. "We continue to urge physicians to discuss alternate treatment options with their patients, including patients currently receiving Doxil who may be approaching the end of their allocation."