The contract manufacturing arm of German pharmaceutical group Boehringer Ingelheim confirmed yesterday that the clinical trial materials supplied to TeGenero for use in the trial that left six men with serious adverse reactions complied with regulations.
The two companies had entered into an agreement in 2003 for the production of Good Manufacturing Practice-grade CTM of the TeGenero compound TG1412, a monoclonal antibody in development for inflammatory diseases and leukaemia.
BI said it decided to undertake an internal investigation into the quality of the drug after news of the hospitalisation of the six clinical trial volunteers broke last week. Documentation and the release procedure for the material it supplied checked out with all pharmaceutical and legal requirements.
The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) is investigating the trial to see if proper processes were adhered to, but has said it does not expect to complete the probe for several weeks. Meantime, there have been signs that the men have started to stage a recovery, although two remain in a critical condition.
