LONDON - British Biotech plc has appointed a new CEO to replace founding CEO Keith McCullagh, who is being forced to step down following severe problems at the company. He will be replaced Sept. 23 by Elliot Goldstein, who joins from London-based SmithKline Beecham plc, where he is senior vice president and director of worldwide strategic product development.
British Biotech, based in Oxford, also said it will continue two clinical trials, despite the fact that they have been unblinded on several occasions. This decision follows discussions with the FDA and the European Medicines Evaluation Agency in which both agencies agreed that the potential impact of the improper unblinding would be assessed as part of the regulatory review process.
Both trials - of the oral cancer treatment marimastat as a monotherapy in pancreatic cancer, and of Zacutex for the treatment of acute pancreatitis - are due to report results in the first half of 1999.
British Biotech began discussions about continuing the trials after it emerged that its director of clinical research, Andrew Millar, had unblinded them. Millar was subsequently fired. The company commissioned a third party to audit the trials, and said it is satisfied that there are no safety issues which would require them to be stopped. In addition, the company claimed the information gained by the unblinding of the two studies has not been used to affect the conduct of the studies. The audit was submitted to regulators.
Following his dismissal, Millar went public with his worries about the trials, and raised other concerns about the way British Biotech was being run. The pressure this generated resulted in McCullagh's decision to step down. - Nuala Moran