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Executive Summary

BEECHAM's EMINASE AMBULANCE STUDY IN 10,000 PATIENTS will be conducted at more than 100 centers in 11 European countries. The thrombolytic Eminase (APSAC) will be administered by doctors or trained paramedics at home or in the ambulance prior to a patient's admission to the hospital. Patients will continue to receive either APSAC or placebo on admission to a hospital under the design of the double blind placebo study. The multi-national effort will be the largest pre-admission study on the drug to date. Called the European Myocardial Infarction Project, the study will be conducted at a minimum of ten centers in each of the 11 countries, which include Britain, France, West Germany, Spain and Italy. Eminase has been the subject of smaller scale pre-admission studies in France; some are ongoing, and the safety profile exhibited in that testing has been "satisfactory," Beecham said. The drug Eminase will be given in a single, 30 unit injection over 4-5 minutes in the European study. Administration will be double-blind and placebo controlled. The study is expected to take about two years to complete. Eminase was chosen for the study because of its speed of administration and rapid action, Beecham said in a Feb. 3 press release. The study is being coordinated by a European collaborative group directed by Clinical Pharmacology Professor Jean-Pierre Boissel at the Hospital Neuro-Cardiologique, Lyon. The hospital has been involved in Eminase testing before, and has also coordinated major, multi-national studies, Beecham said. Beecham is planning to file a product licensing application with FDA for Eminase in June for use of the drug on admittance to a hospital. The filing will include data from a recently completed British study, where the drug was given to over 1,000 patients after hospital admission. The study was concluded in November "when it became clear that the death rate of patients treated with Eminase was about half that of those treated with placebo injections," Beecham's release said. Both treatment groups received standard nonthrombolytic therapy for heart-attacks. Eminase is approved for marketing in West Germany and Belgium. The European study is likely to facilitate U.S. approval of Eminase in the way that the Italian GISSI study helped clear streptokinase through FDA: it is a large-scale project which will probably generate substantial mortality data. Last spring, an FDA advisory panel pointed to the GISSI study as an important basis for recommending streptokinase as an effective agent in reducing mortality ("The Pink Sheet" June 1, 1987 p. 4). The GISSI study involved 11,712 evaluable patients enrolled in 176 coronary care units over a 17 month period. Neither SmithKline nor Hoechst-Roussel currently has plans to test their streptokinase products (Kabikinase and Streptase, respectively) in a pre-admission setting in the U.S. One barrier to testing is the fact that U.S. doctors do not routinely travel with ambulance crews, as they do in Europe. Genentech is planning pre-admission testing for Activase.

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