Pacira to stop making DepoCyt due to long-term production problems
The New Jersey, US firm announced the discontinuation in a US Securities and Exchange (SEC) filing on June 29, explaining the decision was a result of persistent technical issues that are "specific to the manufacturing process."
The firm told us "On June 29, 2017, Pacira informed the FDA, EMA, Health Canada, and our distribution partners Leadiant and MundiPharma, that it will discontinue the production of DepoCyt(e) due to ongoing technical issues related to the product’s manufacturing process—which have persisted despite our corrective efforts."
Pacira said it will cease production of the drug at a facility in San Diego, US and lay off staff involved in manufacture.
The firm predicted that the decision will cost it around $5m. It also hinted that it may lease the San Diego plant, including an estimate of $500,000 in "potential sub-lease income for the facility."
DepoCyt, or DepoCyte as it is known in Europe, is used to treat lymphomatous meningitis, a rare cancer that strikes the spinal cord and brain.
It is based on Pacira’s DepoFoam extended release technology in which active pharmaceutical ingredients (API) are surrounded by a liposomal coating that enables them to be released steadily over up to 30 days.
In the SEC filing Pacira stated that DepoCyt generated 2.5% of the $276.4m in revenue it generated in 2016.
The majority, 97.5%, of the firm's revenue comes from the anaesthetic Exparel (bupivacaine), which is also based on the DepoFoam technology. The drug is made by Patheon NV under a contract signed in 2014.
Pacira has been trying to solve production problems identified by UK and French inspectors who visited the San Diego facility in 2012.
While it declined to go into specific on the manufacturing problems, Pacira did make clear that they are specific to the drug.
It told us "This issue is exclusive to the manufacturing of DepoCyt(e) and has no relevance to the production of Exparel, which has a distinct manufacturing process using different equipment in a separate facility."