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SEARLE CYTOTEC STUDY IN SOVIET UNION WILL BEGIN EARLY NEXT YEAR; SEARLE AGREEMENT, ARNOLD & PORTER VENTURE REFLECT GROWING INTEREST IN U.S.S.R.

Executive Summary

A study of Searle's Cytotec (misoprostol) in 100 Soviet duodenal ulcer patients is scheduled to begin early in 1989 under an agreement with the Soviet foreign trading company Biocard, the U.S. firm announced Dec. 15. The comparative, double-blind study, which also involves an anti-ulcer compound developed in the Soviet Union, will be conducted under the auspices of the U.S.S.R. Cardiology Research Center, Academy of Medical Sciences. Searle said it expects to complete the efficacy study during 1989. The arrangement provides Searle with a foot in the door of a large, virtually untapped market at a time when the Soviet government is attempting to expand trade with the West under the doctrine of perestroika. "Searle has secured the right to use data generated by the study to seek approval to market Cytotec in the U.S.S.R.," the release states. "In addition, Searle has the right of first refusal to license exclusively any gastrointestinal compound Biocard wishes to license outside the U.S.S.R." Biocard is the foreign trade arm of the Soviet Union's health agencies. Currently approved in 43 countries, Cytotec could receive U.S. approval before year end. FDA's Gastrointestinal Drugs Advisory Committee agreed by a nine to one vote in September to recommend Cytotec's approval for prevention of NSAID-induced gastric ulcers ("The Pink Sheet" Sept. 19, p. 3). Indicative of the growing interest in entering the Soviet market, the Washington, D.C. law firm Arnold & Porter announced Dec. 13 that it has established a joint venture between its APCO Associates consulting arm and a Soviet trade group, INFEKS. A consulting cooperative affiliated with the Soviet Union's Ministry of Foreign Economic Relations, INFEKS was formed six months ago to foster trade with the West. Together, INFEKS and APCO are planning "to encourage Western business development in the Soviet Union," Arnold & Porter Managing Partner James Jones said at the briefing. Jones said that initial discussions have "yielded solid interest from U.S. businesses and Soviet enterprises." INFEKS President Vladimar Gusinsky will be meeting with U.S. businesses during the week of Dec. 19 to discuss possible joint venture agreements. The APCO-INFEKS joint venture is planning to open a Moscow office during the first quarter of 1989. APCO anticipates setting up about 12 joint ventures this year, a spokesperson said. According to Jones, there have been 10 U.S.-Soviet joint venture arrangements established since Soviet President Mikhail Gorbachev began a program of economic restructuring in 1987. Commenting on the Soviets interest in encouraging East-West business relationships, Jones said the Soviets "are considering major adjustments to the 49% ceiling on Western ownership of joint ventures, and are in the process of addressing currency convertibility and countertrade among other financial issues." In addition, the U.S. Commerce Department has asked the Soviet Union to host a day of seminars on commercial opportunities for U.S. health care firms in the U.S.S.R. The seminars would be held during the second meeting of the U.S./U.S.S.R. Working Group on Medical Equipment and Supplies, which is tentatively scheduled for late February.
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