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Executive Summary

BRITISH BIO-TECHNOLOGY GROUP's COLLAGENASE INHIBITOR ADJUNCTIVE treatment for metastases of breast cancer is projected to move into Phase I/II clinical trials "toward the end of 1990," according to the company's CEO Keith McCullagh. The British Bio-technology exec told a Nov. 28 conference sponsored by Robertson Stephens that the firm is developing an injectable collagenase inhibitor as an adjunctive therapy in preventing metastases of breast cancer from attacking surrounding bone. Collagenase inhibitors are designed to block the human protein responsible for bone and cartilage destruction in rheumatoid and ostoearthritis. British Bio-technology's lead collagenase inhibitor compound, BB 94, has shown activity in animal models, McCullagh said. The collagenase inhibitor agents are being developed for arthritis indications by SmithKline Beecham under the licensing and R&D collaboration between the two firms forged earlier this year ("The Pink Sheet" March 20, T&G-3). The collaborative development project for a second generation TPA between British Bio-technology and SmithKline is apparently in limbo until the beginning of next year. McCullagh said that SmithKline Beecham is currently considering the future of the "second generation thrombolytic entity that has an increased activity over TPA [and] has a prolonged half-life" as a "potential development candidate as a back-up to Eminase." The restructuring of SmithKline and Beecham has delayed a final decision on the second generation product. "We expect," McCullagh said, "to be in the position to have a fair idea of the product plans for that by next January." The Oxford, England firm could then plan for the initiation of Phase I trials. British Bio-technology and SmithKline Beckman entered into a collaborative R&D program in mid-1987 for the development of thrombolytic products based on recombinant DNA and gene synthesis techniques ("The Pink Sheet" May 18, 1987, T&G-5). Under the agreement, SmithKline has responsibility for developing "new patentable compounds" resulting from the research and, in return, will receive exclusive worldwide marketing rights. British Bio-technology will receive royalties from any product sales. British Bio-technology was established in 1986. The private company completed its third round of financing in June, raising $ 35 mil., and is currently planning to enter Phase I clinical trials next year with an AIDS vaccine in addition to the collagenase inhibitor for breast cancer. Besides SmithKline Beecham, the firm also has collaborative agreements with J&J's McNeil Consumer Products for the development of an HMG-CoA reductase cholesterol-lowering agent and with Pfizer on the role of endothelial cells in vascular disease.

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