GENENTECH's ACTIVASE (TPA) ADDS REDUCED MORTALITY INDICATION

Executive Summary

GENENTECH's ACTIVASE (TPA) ADDS REDUCED MORTALITY INDICATION following FDA okay for the expanded claim on Feb. 23. The agency told Genentech that it can include in labeling statements on TPA's effect on the reduction of infarct size and mortality. Activase (alteplase, tissue plasminogen activator) was originally approved for use in "the lysis of thrombi obstructing coronary arteries, the improvement of left ventricular function and reduction of the incidence of congestive heart failure associated with acute myocardial infarction." Since its approval in November 1987, Activase has been at a labeling disadvantage to the other approved thrombolytic, I.V. streptokinase, which has carried both the reduced mortality and anti-thrombolytic indications. Streptokinase, marketed by Hoechst-Roussel under the brand Streptase and SmithKline and Kabi under the Kabikinase brand, was also approved in November 1987. "Despite widespread belief within the medical community that Activase does indeed save lives, we had been prevented from proactively marketing the life-saving benefits of Activase to physicians," Genentech Senior VP-Marketing James Gower observed. "With this approval, we can effectively communicate the key benefit of Activase -- namely, it saves heart attack patients' lives." The Activase mortality claim is based on two studies submitted to FDA -- the Anglo-Scandinavian Study of Early Thrombosis (ASSET), where mortality was reduced by 25% from 9.8% in the control group to 7.2% with Activase; and the European Cooperative Study Group (ECSG) trial, where mortality after 21 days was reduced from 6.3% to 3.7% with Activase. However, the Activase mortality results in the two trials used to support the expanded claim have not demonstrated superiority over streptokinase mortality results. Activase currently holds about two-thirds of the thrombolytic market, Genentech said. The product generated $ 155 mil. in sales in 1988. In an effort to boost market-share and expand the overall use of thrombolytics to treat myocardial infarction, Genentech hired Boehringer-Ingelheim's 400-person sales force to detail Activase to office-based physicians. The agreement will begin May 1 and remain in effect until at least the end of 1991.