Pacira Shutters DepCyt Operations After Years of Manufacturing Problems
Unable to resolve persistent manufacturing problems, New Jersey-based drugmaker Pacira Pharmaceuticals is ending production of its DepoCyt chemotherapy drug and closing the California plant where it is made.
Pacira informed the FDA, EMA, Health Canada and drug distribution partners Leadiant and MundiPharma of the move June 29, the same day the company filed an 8K “special events” notice with the U.S. Securities and Exchange Commission.
“The decision to discontinue DepoCyt(e)—although the appropriate path forward based on the availability of the product—was not one taken lightly,” company spokesperson Susan Mesco told FDAnews.
Granted accelerated approval by the FDA in 1999 and full approval in 2007, DepoCyt is a sustained-release injectable liposomal formulation of the chemotherapy agent cytarabine, using the company’s proprietary DepoFoam drug delivery technology in the treatment of lymphomatous meningitis.
The quality and safety of the product currently distributed to customers and patients is not in question, Mesco said, but given alternative therapies on the market “Pacira believes that it is in the best interests of patients to permanently discontinue the product, rather than face the prospect of prolonged uncertainty about product availability.”
The company cited “persistent technical issues specific to the DepoCyt manufacturing process” as the reason behind discontinuing the drug but did not elaborate on specific problems. The FDA has issued Pacira a string of Form 483s from 2009 to 2014 with observations ranging from failing to perform pesticide tests on drug ingredients to minor deficiencies in aseptic drug processing conditions, laboratory controls, paperwork and batch testing.
In 2012, Pacira temporarily ceased manufacturing DepoCyt (styled in Europe and U.K. as DepoCyte) bound for the EU market and issued a limited recall after an inspection report by the U.K.’s Medicines & Healthcare products Regulatory Agency (MHRA) raised sterility concerns. Production resumed in January 2013 with MHRA approval.
DepoCyt only accounted for approximately 2.5 percent of Pacira’s total revenues for 2016, with 95 percent of the drugmaker’s revenue coming from Exparel, a surgical painkiller also based on its DepoFoam extended-release technology.
Exparel, which is produced at a different facility using different equipment and “a distinct manufacturing process,” is not affected by the DepoCyt decision, Mesco said.