LONDON ¿ There is further woe at British Biotech plc with the failure in U.S. Phase III trials of Zacutex, for acute pancreatitis. The 1,500-patient study did not reach its primary endpoint in that there was no significant difference between the number of deaths observed within 28 days of treatment in patients receiving either 10 milligrams or 100 milligrams of Zacutex, or placebo. The company is halting development, axing an 1,800-patient trial of Zacutex as a treatment for pancreatitis induced by the diagnostic procedure endoscopic retrograde cholangio-pancreatography (ECRP).

Elliot Goldstein, CEO of British Biotech, told BioWorld International, ¿It is always disappointing to see negative results in Phase III, but it happens in 30 percent of cases. But you have got to stop drilling wells at some point. We have decided to cut our losses, and go elsewhere.¿

The company¿s shares rose by 0.25 pence to 16.25 pence when the news was announced on March 25.

At the same time, Goldstein announced that the strategic and operational review of British Biotech, initiated six months ago when he took over as CEO, is complete. The company, based in Oxford, will now be making moves to expand its pipeline and focus its development capability on getting projects to proof-of-principle and then partnering them, rather than going it alone through to commercialization, as was previously the strategy.

The new business strategy is predicated on the company¿s lead compound, the oral anticancer agent marimastat, being successful. ¿The business plan is based on marimastat being successful at the back end of the program; the later studies will lead to a [regulatory filing],¿ Goldstein said.

¿The strategy will enable us to create success and value, whether marimastat is successful or not, but it will be more difficult if marimastat does not make it,¿ he added. Discussions with potential marketing partners for marimastat are progressing.

Sixty people will be laid off at the company, cutting the head count to 290 by the middle of 2000. Nineteen of the cuts, which took immediate effect, were at the U.S. clinical and regulatory subsidiary, British Biotech Inc., in Annapolis, Md. Seventeen staff members left corporate and development functions in Oxford, and the remaining cuts will occur over the next 18 months, as Phase III trials of marimastat are completed.

The savings from the ECRP trial will be #1 million (US$1.6 million). ¿Even if we had achieved a positive result when the study finished next January, it would have needed #2 million to #3 million for a second study. In other words, the total expenditure would have been very high,¿ Goldstein said.

Overall savings from the restructuring will amount to an annualized savings of #10 million. ¿We will cut out #6 million of expenditure for the year beginning May 1999, and #10 million in the next year,¿ Goldstein said.

Seeking Re-Balance¿ For Company

Peder Jensen, development director and chief medical officer, is to leave the company. He will be replaced by Giles Campion, who joins from SmithKline Beecham plc, of London, where he was vice president and director of the cardiopulmonary therapeutic area.

British Biotech said its future strategy will be to focus on metalloenzyme inhibition programs. The company will aim to take one compound into development annually. Apart from marimastat, the company currently has only two other compounds, BB-3644 and BB-10153, both in Phase I trials, in development. ¿There is certainly an imbalance in the pipeline,¿ Goldstein said. ¿It would be good to have more concentration in Phase II. We have not been exploiting our research capability as well as we could have. When the company was preparing to commercialize marimastat and Zacutex, the focus was moved to scaling-up activities, and research suffered to an extent. Now, we need to re-balance the company, get more compounds into the clinic and start partnering.¿

At least 200 metalloenzymes can be identified on current human genomic databases, and a further significant number are found in pathogenic bacteria and fungi. British Biotech says these control a wide range of biological functions and, as a consequence, metalloenzyme inhibitors should be effective in cancer, and inflammatory and infectious diseases.

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