J&J seeks end to Doxil shortage as Ben Venue signs consent decree
pharmafile | January 28, 2013 | News story | Manufacturing and Production | Ben Venue, Boehringer, Caelyx, Doxil, J&J, JJ, Janssen
Johnson & Johnson says it has taken steps to establish new supplies of its cancer drug Doxil/Caelyx, which remains in short supply in the US, Europe and elsewhere, via an alternative manufacturing route.
Shortages of Doxil (liposomal doxorubicin) have been in effect since Boehringer Ingelheim subsidiary Ben Venue Laboratories was forced to suspend production at its facility in Bedford, Ohio, in November 2011 because of quality violations.
Ben Venue has just signed a consent decree with the FDA which prevents it from manufacturing some products until the deficiencies have been remedied, but leaves it able to product some others to help alleviate shortages.
“Regarding Doxil/Caelyx, we had made significant progress to restore a reliable supply,” said J&J’s vice president of investor relations Louise Mehrotra during the company’s fourth quarter results call last week.
“An alternate manufacturing approach consisting of a collaboration between [Ben Venue] and another supplier to complete end-to-end production of Doxil/Caelyx was approved in the EU and Japan late in 2012 and in Canada earlier this month,” she added.
J&J’s Janssen Products subsidiary sent a letter to healthcare professionals in the US earlier this month that one lot of Doxil 20mg/10ml product manufactured by the new process has been released into the supply chain, even though it has not yet been approved by the FDA.
“While Janssen continues to work with the FDA to seek approval of the alternate manufacturing solution, the agency is exercising its regulatory discretion to release Doxil manufactured through this approach to the US market to ensure continued full access to Doxil for healthcare providers and their patients,” said Mehrotra.
The lot has however undergone a full Janssen internal review to ensure that it meets quality and safety standards, said the company, adding: “Our longer-term solution involves transitioning of Doxil manufacturing to additional suppliers.”
In the EU, J&J is still operating a managed access programme to eke out supplies of Caelyx until shipments have been restored, although in the US Janssen said in October 2012 that full access to Doxil had been restored.
Phil Taylor
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