British Biotech and BresaGen Terminate E21R Development Agreement.Business Editors & Health/Medical Writers OXFORD, U.K. & SYDNEY, Australia--(BUSINESS WIRE)--July 23, 2002 British Biotech (LSE LSE - Language Sensitive Editor :BBG BBG Brooklyn Botanic Garden BBG Broadcasting Board of Governors BBG Bloomberg (financial company) BBG Bundesbeamtengesetz (German Law) BBG Bergbau-Berufsgenossenschaft (Germany) ; NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BBIOY) and BresaGen Ltd (ASX ASX See: Australian Stock Exchange :BGN BGN In currencies, this is the abbreviation for the Bulgarian Lev. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. ) today announced that they have terminated their collaborative agreement to develop the GM-CSF GM-CSF granulocyte-macrophage colony-stimulating factor. Granulocyte/macrophage colony stimulating factor (GM-CSF) A substance produced by cells of the immune system that stimulates the attack upon foreign cells. 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 leukemia (AML AML - A Manufacturing Language ) cells. As already announced with the company's preliminary financial results on July 5, 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 leukemias 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 leukemia. BresaGen has placed patient accrual on hold in its two clinical studies in adult chronic myelomonocytic leukemia (CMML CMML Chronic Myelomonocytic Leukemia CMML Continuous Media Markup Language CMML Civilian Manpower Management Letter ) and rheumatoid arthritis while it works with the Hanson Center for Cancer Research and the Institute of Medical and Veterinary Science The Institute of Medical and Veterinary Science (IMVS) is a public research body located in Adelaide, South Australia, that combines laboratory services, teaching and research. to review other data and discuss further the possible repetition of some of the critical pre-clinical studies. British Biotech has written off (pound)0.3 million in respect of the unamortized amount of milestone payments made to BresaGen. This charge, which was not included in the preliminary financial results for the year ended April 30, 2002, will be reflected in the published financial statements for the year ended April 30, 2002. E21R was discovered by the Hanson Center 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 program in which British Biotech had worldwide commercialization rights for all clinical indications. These rights now revert to BresaGen. Enquiries: British Biotech plc Dr Elliot Goldstein, Chief Executive Officer Tel: 01865 781166 Media contacts for British Biotech John Olsen/James Longfield, Hogarth Partnership Tel: 020 7357 9477 BresaGen Ltd Dr John Smeaton Tel: +61 408 823426 Background Notes British Biotech's Product Portfolio now comprises four products, three in clinical development and one in late-stage pre-clinical development: BB-10901 - A Tumor-Activated Prodrug product, currently in Phase I/II trials in small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. . British Biotech acquired exclusive European and Japanese development and commercialization rights to BB-10901 from ImmunoGen Inc. (Boston, USA) in May 2000. MG98 - A 2nd generation antisense inhibitor of DNA methyltransferase, a nuclear enzyme implicated in uncontrolled tumor growth. British Biotech acquired exclusive European development and commercialization rights to MG98 from MethylGene Inc. (Montreal, Canada) in February 2002. BB-10153 - A novel thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts. thrombolytic 1. dissolving or splitting up a thrombus. 2. an agent that dissolves or splits up a thrombus. , in Phase II proof-of-principle studies in heart attack patients. The study is being conducted by the Thrombolysis in Myocardial Infarction Thrombolysis In Myocardial Infarction (TIMI) is a large randomized controlled trial into myocardial infarction (heart attacks) and the use of thrombolysis. External links
BB-83698 - Targeted at community-acquired pneumonia (hospitalized patients), BB-83698 is the lead peptide deformylase inhibitor from British Biotech's Antibiotic Program. In completed pre-clinical studies BB-83698 has shown high potency against a range of gram positive bacteria, including several drug-resistant strains. The toxicology studies necessary to allow human dosing have been carried out and final analysis of data is nearing completion. A Phase I clinical study in healthy volunteers, to determine the safety and pharmacokinetics of single doses of an intravenous formulation, is expected to begin in October 2002. This news release contains forward-looking statements that reflect the Company's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process. |
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