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SMITHKLINE BEECHAM's EMINASE SCHEDULED FOR OCT. 31 REVIEW

Executive Summary

SMITHKLINE BEECHAM's EMINASE SCHEDULED FOR OCT. 31 REVIEW by FDA's Blood Products Advisory Committee. In addition to reviewing the thrombolytic agent, the panel will discuss the testing of blood donors for hepatitis C (non-A, non-B) and donor re-entry algorithms for HIV-1, according to FDA. The meeting will begin at the Bethesda, Md. Ramada Inn at 8:30 a.m. Beecham filed its Product License Application for Eminase (anistreplase) in June 1988. The previous year, a major efficacy study was discontinued when it was found that the use of the plasma-derived thrombolytic agent resulted in a 47% reduction in 30-day mortality when compared against placebo. Eminase is currently approved in five countries outside the U.S., including the U.K. Clinical data on Eminase already published show comparable-to-favorable efficacy vis a vis Genentech's TPA product Activase. However, Eminase will have a price advantage over Activase, which runs from $2,000 to $2,200 per administration. In addition, Eminase can be administered intramuscularly in two to four minutes; Activase is administered intravenously over a couple of hours. Prior to filing its Eminase PLA, Beecham entered into a co-promotion agreement with Upjohn, effectively increasing its U.S.-based hospital sales force to 300 reps. Genentech, whose sales force numbers about 200 reps, countered with its own co-promotion agreement, under which Boehringer Ingelheim's 400 U.S. reps would promote TPA to office-based physicians. In addition, Genentech said it would increase its own sales force by 50%, to 300 reps by the end of 1989. Meanwhile, Beecham's merger with SmithKline Beckman last summer will put over 1,000 sales and marketing people behind Eminase in the U.S. With the possibility that Eminase could be approved by late 1989, the stage is set for a pitched battle in the U.S. thrombolytic market. An article published in the Oct. 9 issue of Barron's reports that Genentech last summer circulated a memo to financial analysts highlighting the safety and efficacy of Activase over Eminase, even though a comparative trial was not conducted. SmithKline Beecham said that a large U.K. study directly comparing Activase and Eminase is now in progress.

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