EMA Says Ben Venue's Anticancer Drugs Should be Manufactured in Another Facility

Mar 22, 2012

The European Medicines Agency (EMA) has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA’s review of all fourteen centrally authorized medicines that were produced at the site.

Presently, Ben Venue is the only facility that manufactures the anticancer medicines Caelyx (doxorubicin hydrochloride) and Ceplene (histamine duhydrochloride) for the European Union market. While the transfer takes place, the EMA has recommended that the marketing authorizations for both medicines be maintained because they are considered essential for patients and no alternative suppliers or formulations are available. The Agency also added that no concerns have been raised from the safety monitoring of these medicines.

For Caelyx, the EMA explained in a statement that no new patients should be started on the treatment. This recommendation will remain in place until the sterile filtration and aseptic filling processes have been transferred to a new manufacturing site, which should be completed by September 2012. Following this, Janssen-Cilag International NV, which is the marketing authorization holder, will transfer all the remaining steps in the manufacturing process to a new site by the end of 2014.

Janssen-Cilag is also required to promptly report any safety concerns, as well as submit a monthly report detailing reports on effects that could be related to sterilization problems.

For Ceplene, manufacturing processes must be transferred by the marketing authorization holder (EpiCept GmbH) by the end of 2013. In the meantime, the company must continue to visually inspect vials for signs of particle contamination.

The EMA’s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011 after an inspection identified problems in the company’s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing. The decisions regarding Caelyx and Ceplene mark the end of the review. For the previous twelve medicines in the review, the EMA recommended that Ben Venue be removed as a manufacturing site. The review also resulted in the suspension of the marketing authorizations for the skin infection medicine Vibativ and the diagnostic agent Luminity until a suitable, alternative manufacturing site is approved.

Ben Venue Laboratories is the manufacturing arm of Bedford Laboratories, which is a Boehringer Ingelheim company.

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