LONDON - The management of British Biotech plc stepped down last week at the annual general meeting, with outgoing chairman John Raisman declaring the company “will now begin to move forward again“ - but with many of the issues that forced the change of personnel still left unresolved.
The new chairman, Chris Hampson, and CEO Elliott Goldstein inherit the legal case against Andrew Millar, former director of clinical research, who was dismissed in April for allegedly discussing confidential company information with third parties. Millar countersued for unfair dismissal.
As a result of Millar's accusations, Oxford-based British Biotech is in the thick of inquiries by the U.S. Securities and Exchange Commission and the London Stock Exchange, which are looking into possible inappropriate share dealings by directors. In addition, there remains a question mark over the status of two clinical trials, following their unblinding by Millar.
The general meeting coincided with the release of results for the first quarter, ended July 31, showing a loss of £9.2 million (US$15.6 million), up from £9 million for the same period in 1997. Turnover was up, at £504,000 compared to £257,000 for the same period last year. Overall, expenditure of £12 million was slightly down, from £12.1 million in the first quarter of 1997, which the company said reflected cost-cutting measures instituted in May. The company had £120.7 million cash as of July 31.
Positive developments included the commencement of Phase II trials of the oral anticancer treatment marimastat by Tanabe Seiyaku Ltd., of Osaka, British Biotech's Japanese licensee. This event triggered the payment of a US$5 million milestone payment. The trial is testing a combination of chemotherapy plus marimastat in advanced gastric cancer patients. Further trials are planned in other tumor types.
A Phase III trial of Zacutex, used prophylactically to protect patients from developing pancreatitis when undergoing endoscopic retrograde cholangio-pancreatography (ERCP) has also begun. In ERCP, an X-ray contrast medium is infused into the pancreatic duct prior to radiography. Acute pancreatitis is a recognized complication in 10 percent of patients undergoing this procedure.
The 1,800-patient, double-blind, placebo-controlled trial has the well-defined primary endpoint of acute pancreatitis, induced by ERCP procedure, which British Biotech says can be rapidly assessed. However, the company adds that it is likely that a second pivotal trial will be necessary for registration of Zacutex, an inhibitor of platelet activating factor, in this indication.
Phase I Trial Of BB-3644 Nearly Done
There was also progress with early-stage development of BB-3644, a combined inhibitor of tumor necrosis factor and matrix metalloproteinases, which is orally available. A decision on which disease indications to investigate in Phase II will be made once Phase I is completed at the end of 1998.
Results of Phase I trials of BB-10153, a genetically engineered protein with clot-dissolving and antithrombotic properties, are expected before the end of the year. During the first quarter, British Biotech demonstrated an economically viable production route of the compound, triggering a £400,000 milestone payment from Japanese partner Japan Tobacco, of Osaka. British Biotech intends to find a development partner with experience of the cardiovascular market for BB-10153. *
Postponement Described As Precautionary