The EMA has warned Pacira Pharmaceuticals about a number of manufacturing deficiencies following an inspection of the firm’s plant in the US.
The agency said the inspection – which was conducted by UK and French regulators – revealed a number of deficiencies relating to the production of Pacira's drug DepoCyte (cytarabine), notably a lack of adequate sterility assurance that could pose a ‘theoretical risk’ to patients.
The European Medicines Agency (EMA) added that the drug – which is used to treat lymphomatous meningitis, a rare cancer that strikes the spinal cord and brain – should be recalled in countries where alternative treatments are available.
Potential alternatives include non-liposomal cytarabine, methotrexate or thiotepa, however, as the EMA points out not, all are approved for the treatment of lymphomatous meningitis.
Pacira has also been told to halt production of the drug and is not likely to resume operations any time soon according to the agency.
“Production and batch release of DepoCyte are currently on hold. New batches of DepoCyte will only be manufactured once all deficiencies have been resolved and a re-inspection has indicated the manufacturing site to be compliant with good manufacturing practice (GMP) requirements.”
The EMA did not detail the deficiencies at Pacira San Diego plant. However, in its latest SEC filing the firm reported that the UK MHRA had detected “certain critical and major deficiencies in the DepoCyte manufacturing line.”
The firm also said that it has started work on a remediation plan to address the problems, one part of which involves renovation of the facility by DPR Construction which it initially hired to increase capacity in May.
DepoCyte – which generated $1.2m for Pacira in Q2 according to the firm’s last financial report - is produced by Pacira using its DepoFoam extended release technology.
The 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 – was licensed by Novo Nordisk in 2011.
However, according to Pacira’s latest quarterly filing Novo terminated the agreement after discontinuing development of an unidentified drug candidate.