Wednesday May 2
OXFORD, U.K.--(BUSINESS WIRE)--May 2, 2001--British Biotech (NASDAQ:BBIOY)
British Biotech today announced:
British Biotech has conducted interim analyses of its two remaining phase III clinical trials of the oral matrix metalloproteinase inhibitor (MMPI), marimastat, to determine whether there would be potential benefit to patients by continuing these studies. The two trials are Study 173, in patients with non-small cell lung cancer, and Study 183, in patients with resected pancreatic cancer. British Biotech and its licensing partner, Schering-Plough Corporation, agreed to a set of pre-defined criteria for stopping the trials if no benefit was demonstrated.
Data analysis of Study 173 showed that it met the pre-defined criteria for stopping. Accordingly, investigators and patients have been informed that this trial has been terminated. Conversely, Study 183 is being continued as the data from this trial did not meet the stopping criteria.
Long-term, follow-up of Study 145, in patients with gastric cancer
At the Fourth International Gastric Cancer Conference, held in New York on April 30, 2001, Mr John Whiting, MB, FRCS, presented 'Marimastat as Maintenance Therapy for Patients with Advanced Gastric or Gastro-oesophageal Cancer: A Randomized Trial'. The presentation analyzed long-term (24-month), follow-up of patients in the marimastat phase III Study 145.
Study 145 was originally reported in August 1999 and, although the primary endpoint was not met, demonstrated a survival benefit for marimastat. These long-term data demonstrated that patients treated with marimastat continue to show survival benefit compared with those who received placebo.
British Biotech chief executive Dr Elliot Goldstein, said: "Study 183 continues because we cannot rule out some potential benefit of marimastat in this setting. However, it is not possible, at this stage, to reach any conclusions about the eventual outcome of the trial. The future direction of the MMPI cancer program is the subject of ongoing discussion with our licensing partner Schering-Plough and with external experts."
This news release may contain forward-looking statements. Any such statements reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. These risks and uncertainties include, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, clinical research, the regulatory approval process, product commercialization and patent protection and the impact of competitive products and third party patents. The risks and uncertainties also include those detailed from time to time in the Company's periodic reports.
Note to Editors
About British Biotech
British Biotech is a research and development stage biopharmaceutical company. Its strategy is to build shareholder value by exploiting its proprietary programs in metalloenzyme inhibition; by discovering and developing new classes of antibiotics; and by working in collaboration with other biotech companies to develop specialist drugs for the treatment of serious illness and retaining commercialization rights for niche markets.
The Company comprises two distinct businesses: a Product Portfolio of six drugs with potential to treat up to 10 serious diseases; and an Antibiotic Program which is capable of yielding multiple product opportunities.
Collaboration with ImmunoGen Inc, USA; targeted at small cell lung cancer.
Collaboration with BresaGen Ltd, Australia; targeted at acute myeloid leukaemia; other leukaemias; rheumatoid arthritis.
Collaboration with Serono SA, Switzerland; targeted at rheumatoid arthritis, periodontal disease.
Collaboration with Serono; targeted at multiple sclerosis; cancer.
Targeted at heart attack/stroke (thrombosis).
Batimastat BiodivYsio(TM) stent
Collaboration with Biocompatibles International plc, UK; targeted at vascular restenosis.
British Biotech's research into the use of metalloenzyme inhibitors in antibiotics is capable of yielding product opportunities in a number of fields. Polypeptide deformylase inhibitors are in development for common respiratory infections such as community-acquired pneumonia. LpxC inhibitors are in pre-development as potential treatments for gram negative bacteria such as those causing urinary tract infections. Also under way are research programs into treatments for severe hospital-based infections and broad-spectrum antibiotics.
Tony Weir, Finance Director
Tel: 011-44-1865 781166
Fax: 011-44-1865 781047
G.A. Kraut Company
Gerard Coffey, Vice President