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ICI ZOLADEX AND DIPRIVAN U.S. APPROVALS EXPECTED BY MID-1989, FIRM TELLS ANALYSTS; STATIL EFFICACY RESULTS ANTICIPATED IN MID-1989, NDA IN U.S. PLANNED FOR 1990

Executive Summary

ICI management is predicting mid-1989 U.S. approvals for its I.V. anesthetic Diprivan and its LHRH agonist Zoladex in its 1989 road show for U.S. analysts. An NDA for Diprivan (propofol) was submitted in August 1986. Commenting on the agent's acceptance in the roughly 40 countries where it is currently marketed, Peter Doyle, executive director for group research and technology on ICI's corporate board, told New York analysts Feb. 27 that the anesthetic has been "received very well, indeed." Doyle said that the drug has "exceeded our expectations and we hope to see registration approval and launch in the middle of this year for the U.S." Zoladex (goserelin), a monthly depot injection for prostate cancer, is currently marketed in 12 countries. ICI submitted an NDA for the agent in August 1987. Doyle said the firm is "hoping for approval in the first half of 1989 for the U.S. and would like to see registration in Japan early in 1990." ICI has NDAs pending for at least two other agents: Catatrol (viloxazine HCI), an orphan drug for the treatment of cataplexy and narcolepsy, and Carwin (xamoterol), a cardioselective beta agonist for the treatment of mild-to-moderate congestive heart failure. Among the firm's late-development stage compounds, Doyle highlighted the aldose reductase inhibitor Statil as "the biggest product potentially, ]but[ the most risky." Doyle reported that its Phase III U.S. trial of Statil (ponalrestat) in 360 patients will be completed by mid-year, and that results will be analyzed during the third quarter. Additional data will be gathered from trials in Germany and Italy. ICI is projecting a 1990 NDA filing in the U.S. for Statil. Merck is also working on development of ponalrestat for complications of diabetes under a co-development/marketing agreement. FDA had placed a limited clinical hold on ponalrestat and other aldose reductase inhibitors in late 1987 because exacerbation of neuropathy was seen in rat studies. The hold, which only prevented initiation of new long term studies, was lifted in October 1988 ("The Pink Sheet" Dec. 12, T&G-5). Doyle reported that the firm currently has 19 compounds in the early stages of development, seven of which are in early clinicals. He identified four research compounds as "particularly exciting": ICI 176,334, an antiandrogen in Phase II for the oral treatment of prostatic cancer that is "potentially very exciting because of the possibility of use in benign prostatic hypertrophy"; ICI 204,219, a leukotriene antagonist in early Phase II studies for asthma and related conditions that has "already given us very encouraging results against bronchospastic challenges"; ICI 192,605, a thromboxane antagonist in Phase I with potential uses in asthmatic and cardiovascular conditions; and ICI 200,880, an elastase inhibitor "with potential for treatment of emphysema" in Phase I study. ICI worldwide pharmaceutical sales were $ 2.1 bil. in 1988. The firm reported that total ICI Americas sales, which includes chemicals, were approximately $ 4 bil. and that pharmaceuticals represent 21% of sales, which would put ICI's U.S. drug business somewhere in the neighborhood of $ 800 mil. Asked about the possibility of ICI acquiring a pharmaceutical company, ICI Chairman Denys Henderson told the analysts that "the answer would be yes, if it were the right one and it didn't cost us an arm and two legs." Henderson added that the firm has a "pretty relaxed approach because we have the cover and we have a very rich vein of new products coming through."

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