LONDON The new management at British Biotech last week set out a revised strategy, including plans to expand clinical trials of its lead compound, marimastat, and find partners in all major markets. This follows a review of the business by chairman Christopher Hampson and CEO Elliot Goldstein, who took over the company in August 1998.
As a result, the company, based in Oxford, said it will close its biological scale-up facility, making 24 staff members redundant, and rationalize commercial functions, closing down the European operations and laying off four more staffers.
Katie Arber, spokeswoman for the company, told BioWorld International the review of ongoing trials of the oral anticancer treatment marimastat was intended to make sure the trials were optimally designed. ¿It involved an internal review and consultations with experts in Europe and the U.S. They uniformly came back with the advice that we should focus on cancer indications where there is a low tumor burden, and reduce the current efficacy hurdle in studies where recruitment is not complete.¿
The company will increase patient numbers in three studies: a non-small-cell lung cancer study, where marimastat is being compared to placebo, is being increased from 300 to 500 patients; an adjuvant pancreatic cancer study, where patients receive marimastat or placebo following surgery, is being increased from 200 to 500 patients; and discussions are under way to increase the size of a small-cell lung cancer study from 360 to 540 patients.
¿By enlarging the number of patients, we can show statistically significant results at a lower percentage difference in longevity between control and treated patients,¿ Arber said. ¿We are now looking for a difference of 10 percent, which is still clinically very relevant, but with the larger numbers will be easier to achieve.¿
Clinical trial centers are being added to accelerate recruitment, and results from the three trials are expected from mid-2001 until mid-2002, which is more than a year later than under the previous design. Five other pivotal marimastat trials have completed recruitment, and results are due over the next two years. Results of the first trial, of monotherapy in pancreatic cancer, are expected to be available in the first quarter of 1999.
However, there is some question as to how the regulators will view the data, as this trial was unblinded by the company¿s former director of clinical research, Andrew Millar. It was his suspension in March 1998, for this and other alleged indiscretions, that finally resulted in the resignation of the previous CEO, Keith McCullagh.
Results of a second pivotal study, of Zacutex in the treatment of pancreatitis, are also due in the first quarter of 1999, but this study also was unblinded by Millar.
British Biotech¿s share price rose by #0.03 to #0.45 when details of the review were announced on Nov. 13.
Commenting on the plans, Hampson said: ¿Our clear message to shareholders today is that the new management team is committed to making changes to create long-term shareholder value. An important step in achieving this is that we will now be working in partnership to develop and market our products. We will continue the restructuring of the company in line with the new strategic direction to ensure a sustainable business.¿
British Biotech also released results for the six months ended Oct. 31 showing a loss of #16.6 million, compared to #10.8 million for the same period in 1997. The loss included a one-time payment of #1.7 million to cover the cost of the changes to the company¿s board of directors.
Revenue was #3.7 million, compared to #300,000 for the same period in 1997. Of this, #3.2 million came from British Biotech¿s Japanese partner, Tanabe, following the start of Phase II trials of marimastat in Japan. Research and development expenditures fell to #18.6 million from #20.6 million, and administrative overhead dropped to #4 million from #5 million in 1997. The reductions reflect a cutback in some operations and a number of redundancies, an nounced in May 1997.
Cash burn fell sharply, to #17.4 million for the half year, from #27.1 million. As of Oct. 31, the company had #115.4 million in cash.