J&J unveils plans to boost Doxil supplies
pharmafile | April 10, 2012 | News story | Manufacturing and Production | Ben Venue, Doxil, J&J, JJ, drug shortages
Johnson & Johnson is planning to transfer filling and packaging of Doxil to another supplier in an attempt to alleviate shortages of the critical cancer medicine.
A spokesman for J&J told Bloomberg that the company could help restore supplies of Doxil (liposomal doxorubicin) by taking bulk product manufactured by troubled production partner Ben Venue Laboratories and finishing it at another unidentified contractor.
Boehringer Ingelheim subsidiary Ben Venue was forced to suspend production at its facility in Bedford, Ohio, last year in order to carry out essential remedial work, and since then J&J has been rationing access to Doxil via a physician allocation programme, which covers around 3,300 patients.
Earlier this month the company said it was limiting access to the drug to current Doxil patients and urged physicians to “discuss alternative treatment options with their patients”. Hundreds of other patients are on a waiting list.
Meanwhile, doctors should certify that patients already on the drug are responding to treatment in order to secure an additional allocation.
At the time J&J said it was looking at a variety of short-term options to restore a consistent supply “ahead of the late 2012 timeframe currently estimated by the external contract manufacturer”. Sales of Doxil fell by 50% to $140 million last year because of the production problems.
The company told Bloomberg that it could secure approval for a new contractor in September, with limited production of Doxil following thereafter.
At the moment, all the products on the market is from unused production batches completed before Ben Venue suspended manufacturing, although the FDA gave a green light in February for limited imports of a generic version of the drug made by Indian drugmaker Sun Pharma.
Last November, President Obama issued an executive order to tackle the growing shortages of medicines used to treat some cancer and other serious diseases.
Phil Taylor
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