Friday, Jun 10, 1994

FDA's Cardio-Renal Advisory Committee Unanimously Recommends Accelerated Activase t-PA Label Change by FDA

Mortality benefit of t-PA over streptokinase confirmed

South San Francisco, Calif. -- June 10, 1994 --

Genentech, Inc. (NYSE:GNE) was pleased that the Food and Drug Administration's (FDA's) Cardiovascular & Renal Drugs Advisory Committee unanimously recommended rapid infusion of the company's thrombolytic, or clot-dissolving drug, Activase® (Alteplase, recombinant) t-PA, as having a clinically sign)ficant mortality benefit in the treatment of heart attacks, and further recommended that the new dosing regimen be incorporated into the product's labeling.

The Committee's recommendations confirmed the sign)ficant survival benefits demonstrated by the worldwide GUSTO* heart attack study, published last September and November in The New England Journal of Medicine. In the GUSTO study, Activase t-PA was administered to heart attack patients rapidly 90 minutes rather than the typical infusion time of three hours which is the method currently approved by the FDA.

"Today's recommendations are an important step toward improving heart attack survival rates in this country," said G. Kirk Raab, Genentech's president and chief executive officer. "As many as 1,700 additional lives might be saved by increased use of Activase t-PA. We hope formal FDA approval of the committee recommendations will soon follow."

Genentech was the primary sponsor of the independent, 41,000-patient GUSTO study, which demonstrated that using an accelerated dose of Activase t-PA plus a blood thinner, IV heparin, saved sign)ficantly more lives from heart attack with fewer complications than the other thrombolytic regimens tested.

GUSTO Results Acknowledged Worldwide

Acceptance of the GUSTO findings by the practicing medical community around the world has been quite apparent from increased use of Activase t-PA since announcement of the study's findings in April of last year. Currently, more than 70 percent of heart attack sufferers receiving thrombolytic therapy in the United States receive Activase t-PA. More t-PA also is being used in Canada, Europe, and elsewhere in the world.

The GUSTO study is the largest heart attack study ever conducted, and was designed to determine conclusively the optimal pharmacological approach to clear blocked coronary arteries that cause most heart attacks. GUSTO found that the accelerated Activase t-PA plus IV heparin regimen increased a patient's chances of survival by 14 percent compared to the streptokinase regimens tested in the trial. The life-savings seen with accelerated t-PA plus IV heparin in GUSTO translated into nine lives saved per 1,000 patients treated, even after accounting for nonfatal stroke.

Several formal cost-effectiveness analyses of the GUSTO results have calculated the cost per year of life saved, which is the most commonly used economic measure applied to life-saving medical interventions.

"Based on the life-saving benefit of accelerated Activase t-PA seen in GUSTO, its cost-effectiveness (about $29,000 - $40,000 per year of life saved) is comparable to other widely accepted life-saving and life-extending treatments such as cholesterol lowering therapy, kidney dialysis, high blood pressure therapy, mammography and open heart surgery," said J. Sanford Schwartz, M.D., executive director, Leonard Davis Institute of Health Economics, University of Pennsylvania.

Moreover, an examination of preliminary one-year follow-up data from the GUSTO study indicates that the life-saving benefits of accelerated t-PA are maintained for one year. Each survivor of a heart attack lives an average of an additional 7 to 11 years, according to expert cardiologists.

Genentech, Inc. is a leading, international biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, California, and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.

* Global Utilization of Streptokinase and t-PA In Occluded Coronary Arteries

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