Comment of Boehringer Ingelheim to the Clinical Trial of TeGenero in the United Kingdom
Ingelheim/Germany, 20 March 2006 - TeGenero and Boehringer Ingelheim had entered into an agreement in November 2003 for the production of GMP-material of TeGenero`s compound CD28-SuperMAB (monoclonal antibody).
Boehringer Ingelheim Biopharmaceutical division produced the substance according to TeGenero`s specifications as a contract manufacturer. Based on the acceptance by the regulatory authorities in Germany and the United Kingdom, the material was supplied to TeGenero “for investigational use only”.
Boehringer Ingelheim was informed that in a phase I trial six healthy volunteers had developed serious adverse drug reactions and are treated at present in a London hospital. An additional review of the manufacturing documentation and the pharmaceutical release procedure has confirmed that the material supplied by Boehringer Ingelheim to TeGenero for preclinical and clinical development complied with all pharmaceutical and legal requirements.
Boehringer Ingelheim expresses its concern for the volunteers and wishes them a speedy and full recovery.
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