British Biotech plc Regulatory update.NEW YORK--(BUSINESS WIRE)--Aug. 20, 1998--British Biotech announces that the Company will be continuing study 128 (marimastat monotherapy monotherapy /mono·ther·a·py/ (-ther´ah-pe) treatment of a condition by means of a single drug. mon·o·ther·a·py n. Treatment of a disorder with a single drug. in pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. ) and study 215 (Zacutex acute pancreatitis acute pancreatitis Inflammation of the pancreas of abrupt onset, often with gallstones and alcohol ingestion Epidemiology 109,000 hospitalizations, 2251 deaths–US; 10-fold ↑ from 1960s to 1980s–reason unclear; ) and is satisified that there are no safety issues which would require these clinical trials to be stopped. The Company held discussions with the United States' Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) and European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) regarding the unauthorized unblinding of these two clinical trials. These discussions were initiated by the Company following a third party regulatory audit which concluded that Dr. Andrew Millar, the Company's former Director of Clinical Research, had unblinded studies 128 and 215 on several occasions in breach of Good Clinical Practice and the Company's standard operating procedures standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. . The audit report prepared by a third party was provided to both regulatory authorities. Both trials are due to report in the first half of 1999. If the results are positive, theCompany will make appropriate regulatory submissions. The data included would then be fully reviewed by the regulatory authorities as is the case for all regulatory submissions. While the Company believes that the information gained by unblinding the two studies has not been used to affect the conduct of the studies, the potential impact of the improper unblinding would be definitively assessed as part of the regulatory review process. This news release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. which reflect the Company's current expectation 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 strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.
CONTACT: British Biotech plc
011-44-1865-781166
Katie Arber, Head of Corporate Communications
or
G.A. Kraut Company
Gerard Coffey, Vice President
212-696-5600
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