Pacira halts production of Depocyt
- Pacira Pharmaceuticals last week disclosed it would discontinue all future production of its DepoCyt formulation of cytarabine for use against lymphomatous meningitis, citing unspecified technical problems in its manufacturing process.
- The New Jersey-based company said it would record a $5 million charge in the second quarter of 2017 as a result of discontinuing production of the drug. The charge includes $2.5 million related to asset write-offs as well as other lease and employee severance costs.
- Sales of Depocyt in the U.S., Canada and EU (where it's sold as Depocyte) accounted for 2.5% of total revenues last year. The news did little to affect Pacira's share price, which held steady at just over $48 a share.
DepoCyt has been on the market since 1999, and uses Pacira's DepoFoam technology to deliver the chemotherapy drug cytarabine over a sustained period.
While it's not clear what technical issues led to the manufacturing halt, Pacira has said the decision to discontinue production "does not affect any product that has already been distributed to customers or administered to patients."
Pacira manufactures Depocyt at a GMP facility in San Diego, California.
Sales of Depocyt and other immaterial product lines totaled $724,000 in the first three months of the year, down 3% from the same period a year prior. Pacira also collects royalty revenues on sales of Depocyt by its commercial partners, Sigma-Tau and MundiPharma.
This isn't the first time Pacria has faced manufacturing issues with Depocyt. The company halted production for Europe in mid 2012 after an inspection by the U.K. Medicines & Healthcare Products Regulatory Agency. This led the European Medicines Agency to recommend a precautionary product withdrawal in European countries where other treatment options exist.
DepoCyt was originally developed at DepoTech, and received accelerated approval in the U.S. in 1999 for the intrathecal treatment of lymphomatous meningitis, a life-threatening complication of lymphoma. Full approval followed in 2007.
DepoTech was acquired by the U.K. company SkyePharma in 1998, and then picked up by a syndicate of venture capitalists in 2007, creating Pacira Pharmaceuticals.
- SEC Form 8-K
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