LONDON ¿ British Biotech plc put most of its past difficulties behind it last week, agreeing to settlements with Andrew Millar, who was fired as director of clinical research in April 1998, and with the U.S. Securities and Exchange Commission (SEC), following an investigation which began in Oct. 1996.

The company, based in Oxford, said it has agreed to withdraw its claims and allegations of improper behavior against Millar, who has agreed to drop his claim against the company for wrongful dismissal. British Biotech refused to say how much it paid to Millar to settle the case.

In May 1998, British Biotech issued a 32-page statement to shareholders, giving an item-by-item rebuttal of allegations made by Millar, following his dismissal. Among these allegations, Millar said shareholders had been misled over the company¿s prospects and that directors sold shares when they should not have. For its part, British Biotech accused Millar of disclosing confidential information and of the unauthorized unblinding of two clinical trials.

Katie Arber, head of corporate communications, told BioWorld International it was inappropriate to interpret the settlement as any sort of judgement on whether the allegations made by either party were right or wrong. ¿What the company wanted to do was settle because we wanted to get on with our business,¿ she said.

It recognized Millar ¿acted in accordance with his medical opinions, his professional obligations to patients involved in clinical trials, his conscience and his view of the best interests of British Biotech.¿

Apart from the legal costs, the Millar affair prompted a sharp fall in British Biotech¿s share price, led to the resignations of CEO Keith McCullagh and chairman John Raisman, and generated a stream of bad publicity for the company.

Despite the settlement with Millar, British Biotech is still subject to an investigation by the London Stock Exchange, which was initiated as a result of Millar¿s allegations. The investigation concerns share dealings by British Biotech directors on Jan. 17, 1995, exactly a month before the company dropped batimastat, then in Phase III trials for the treatment of malignant ascites and malignant pleural effusion.

In the settlement with the SEC, British Biotech and three former directors, Keith McCullagh, Peter Lewis and James Noble, have been issued a ¿cease and desist¿ order. This is for failing to specifically disclose in press releases that cancer antigens, which were taken as surrogate markers of efficacy in the Phase II trials of the company¿s oral anticancer drug marimastat, were an insufficient endpoint on which to base a marketing application to the FDA.

However, the SEC recognized the company made clear that the Phase II trials were being used as a basis for designing the Phase III trials which took the traditional efficacy measures of survival and disease-free interval as the primary endpoints.

In reaching the settlement with the SEC, British Biotech has neither admitted nor denied the Commission¿s findings. ¿Cease and desist¿ is a technical order that does not place any additional requirements on the company and which Arber said is, ¿at the bottom end of the scale of the SEC¿s great powers.¿