British Biotech and BresaGen terminate E21R development agreement
23 July 2002
British Biotech (LSE:BBG; Nasdaq:BBIOY) and BresaGen Ltd (ASX:BGN) today announced that they have terminated their collaborative agreement to develop the GM-CSF antagonist E21R.
The decision to end the collaboration follows further review of new pre-clinical study data that fail to confirm certain aspects of earlier published data on E21R-induced apoptosis in acute myeloid leukaemia (AML) cells.
As already announced with the company's preliminary financial results on 5 July 2002, British Biotech has stopped a Phase II clinical study of E21R in AML patients. In addition, the Company has now been advised by external experts that, in view of the new pre-clinical data, a proposed Phase I clinical study in children with various myeloid leukaemias could not proceed on ethical grounds. This proposed study was considered to be a pre-requisite for efficacy studies in the rare childhood disease, juvenile myelomonocytic leukaemia.
BresaGen has placed patient accrual on hold in its two clinical studies in adult chronic myelomonocytic leukaemia (CMML) and rheumatoid arthritis while it works with the Hanson Centre for Cancer Research and the Institute of Medical and Veterinary Science to review other data and discuss further the possible repetition of some of the critical pre-clinical studies.
British Biotech has written off £0.3 million in respect of the unamortised amount of milestone payments made to BresaGen. This charge, which was not included in the preliminary financial results for the year ended 30 April 2002, will be reflected in the published financial statements for the year ended 30 April 2002.
E21R was discovered by the Hanson Centre for Cancer Research of the Institute of Medical and Veterinary Science in Adelaide. The drug was licensed and developed through manufacture and Phase I testing by BresaGen and subsequently licensed to British Biotech in a collaborative development programme in which British Biotech had worldwide commercialisation rights for all clinical indications. These rights now revert to BresaGen.
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