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Executive Summary

Celltech's TIMP (tissue inhibitor of metalloproteinase) for treatment of rheumatoid arthritis will be licensed in the U.S. "shortly," Celltech Director of Finance Hugh Perrott told a health care investment conference in London Oct. 21-22. TIMP, a human gene encoding protein naturally produced by the body, is thought to be important in controlling connective tissue breakdown. Perrott reported that TIMP and products derived from TIMP "have potential in controlling the advance of rheumatoid arthritis and possibly arresting the disease completely." He said Celltech will "shortly be setting up licensing agreements for the [United] States and Japan." The company plans to retain European marketing rights. Perrott said clinical evidence of TIMP efficacy "is limited because the material has up to now been in very short supply." He maintained that the "potential applications for products derived from this inhibitor extend beyond rheumatoid arthritis" because there is also evidence of efficacy in periodontal disease, cancer and osteoporosis. Perrott forecast "a major announcement about TIMP at the end of the calendar year." The Celltech exec noted that "similar products with slightly different claims" are available or will likely be available from other companies. Asked to specify the competitive products, Perrott said there were three in particular. "I think we're in negotiations with those companies so I've got to keep quiet about those," he said. "I don't think they know quite how valuable their own products are." Celltech is a U.K. firm based in the Berkshire town of Slough. Perrott explained that until recently the company has been "operating a drug discovery and licensing business where we find a new drug and, sponsored by a pharmaceutical company, we develop a production process for it." He said the process is licensed to a sponsor who then takes the product through to market. Perrott added that Celltech has been able to build supply contracts into its licensing agreements and recently has been able to preserve marketing rights "in carefully selected cases." In addition to TIMP, Celltech is developing human growth hormone, calcitonin and modified monoclonal antibodies for the treatment of cancer. Perrott pointed out that American Cyanamid is sponsoring a Celltech program "to redesign monoclonals to improve their ability to carry imaging agents and drugs directly to the tumor site." Perrott said "so far, most attempts by other centers . . . haven't actually succeeded in getting most of the drug to the target" which has led to side effects, just as current chemotherapy. According to Perrott, Celltech has "a way of overcoming this problem and we'll find out just how strong our competitive position is when Cyanamid starts launching a series of diagnostic imaging and therapy products for specific cancers in the early 1990s." The National Institutes of Health is one of eight or nine collaborators in the program. Celltech announced its agreement with American Cyanamid in April ("The Pink Sheet" May 12, "In Brief"). Under the agreement Celltech will recieve $7.5 mil. initially for two years. Perrott noted that Celltech has developed a human growth hormone product identical to natural hGH. He differentiated the product from Genentech's recombinant hGH, Protropin, which he said has produced an immune response in some patients. Perrott said that clinical trials with the Celltech product to date have not shown signs of an immune response. "Because of this, it's possible that the launch of our product in some countries may now be brought forth from 1988," Perrott stated, noting that Serono will market the product worldwide and Celltech will probably sell hGH in the U.K. under its own label. Serono withdrew its human growth hormone, Asellacrin, from the market in May 1985 after the National Institutes of Health reported that three men had died from Creutzfeldt-Jakob disease several years after receiving NIH's hGH therapy ("The Pink Sheet" May 20, 1985, T&G-12). Serono recently received FDA approval to begin clinicals with a recombinant hGH, Saizen, which the company said is the same as natural hGH. Lilly and Bio-Technology General are developing biosynthetic hGH and Unigene announced in March that it had successfully produced natural hGH releasing factor. American Critical Care has exclusive U.S. marketing rights to Bio-Technology General's hGH. Celltech has also developed a genetically engineered calcitonin which Perrott said is cheaper to make and less likely to produce an immune response than the currently marketed product, which is isolated from fish or made chemically. He noted that the firm's sponsor, Sankyo, is getting ready for clinical trials in Japan and that plans for major markets outside Japan "will be arranged shortly." Sankyo is also sponsoring research on tumor necrosis factor, tumor macrophage activating factor and tissue plasminogen activator. Perrott also discussed Celltech's 50/50 joint venture with Boots, Boots-Celltech Diagnostics, whose current products include a kit to measure thyroid deficiency. Perrott said the firm has developed a dual analyte test measuring the fertile period in women and giving two days warning prior to ovulation, which will be sold to infertility clinics in 1987. Additionally, he said a simple OTC product, which has been approved by the Catholic church as a suitable method of birth control, will be available in 1988. Perrott emphasized that the company's long-term goal is to market a range of products for the physician's office.

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