EMA confirms verdict on Ben Venue facility
pharmafile | February 28, 2012 | News story | Manufacturing and Production | Ben Venue, CHMP, EMA, Sanofi
The European Medicines Agency has officially removed Ben Venue Laboratories’ troubled Bedford facility as an approved location for the manufacture of a dozen products approved via the centralised EU procedure.
A total of 14 drugs made by the contract manufacturer at the plant in Ohio, US, had been centrally approved by the EMA.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has now asked the marketing authorisation holders for 12 of the medicines to remove Ben Venue as a manufacturing site from the marketing authorisation.
The 12 products include: Gilead Sciences’ Vistide (cidofovir) for cytomegalovirus retinitis and inhaled antibiotic Cayston (aztreonam); TMC’s Angiox anticoagulant (bivalirudin); Pierre Fabre’s transplant drug Busilvex (busulfan); Pfizer’s antifungal Ecalta (anidulafungin) and cancer drug Torisel (temsirolimus); Lanthaeus’ imaging agent Luminity (perflutren); IDM Pharma’s bone cancer drug Mepact (mifamurtide); Alexion’s complement inhibitor Soliris (eculizumab); Takeda’s Velcade (bortezomib) for multiple myeloma; Astellas’ antibiotic Vibativ (telavancin); and leukaemia/lymphoma treatment Vidaza (azacitidine) from Celgene.
The review of the two other centrally-authorised cancer medicines manufactured at this site, Janssen-Cilag’s Caelyx (doxorubicin) and Ceplene (histamine dihydrochloride), is still ongoing and is expected to be concluded next month.
Boehringer Ingelheim subsidiary Ben Venue suspended production at the plant last November, leading to shortages of some critical medicines in the US including Doxil (doxorubicin), a cancer drug made by Ben Venue and sold by Johnson & Johnson.
The company has already said it intends to phase out its contract manufacturing operations over the coming years, once production of various critical medicines can be taken over by other firms.
Meanwhile, supply problems continue for products manufactured at the plant. Earlier this month, Bedford Laboratories – a sister company to Ben Venue – issued a nationwide recall of anticancer drug cytarabine because of sterility concerns, while the plant is racing to produce methotrexate in response to a critical shortage of the cancer drug across the US.
Earlier this month Sanofi’s Genzyme unit said it had to recall thousands of five-vial packs of Fludara (fludarabine) for similar reasons.
Phil Taylor
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