Caelyx and Ceplene manufacturing should be moved, says EMA

The European Medicines Agency has recommended that the manufacturing processes for the anticancer medicines Caelyx (doxorubicin hydrochloride) from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International NV and Ceplene (histamine dihydrochloride) made by EpiCept (Nasdaq: EPCT) be transferred from the Ben Venue Laboratories in Ohio, United States, to alternative facilities.

A review of shortcomings in quality assurance at the manufacturing site of Ben Venue, a contract manufacturing subsidiary of independent German drug major Boehringer Ingelheim, was started by the EMA last fall (The Pharma Letter November 23, 2011). Problems at the plant have also been blamed for exacerbating US drug shortages

While the transfers are ongoing, the Agency's Committee for Medicinal Products for Human Use (CHMP) is recommending that the marketing authorisations of the two drugs be maintained because both medicines are considered to be essential for patients and no alternative suppliers or alternative formulations are currently available. The Committee also considered the fact that no concerns have been raised from the safety monitoring of these medicines.