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Ruling May Help Troubled Heart Drug Compete : FDA Lets Genentech Call Activase a Lifesaver

From Staff and Wire Reports

Genentech Inc., a biotechnology company whose fortunes have hinged largely on sales of its heart attack drug Activase, said Monday that it has won permission from the U.S. Food and Drug Administration to claim that the medicine can save the lives of some patients.

“With this approval, we can effectively communicate the key benefit of Activase--namely, it saves lives,” the company said in a prepared statement.

Genentech previously couldn’t advertise that Activase could save lives; it was restricted to saying that the prescription drug dissolved clots in coronary arteries, improved heart function and reduced the incidence of congestive heart failure following heart attacks.

There was little reaction on Wall Street to the FDA decision. Genentech shares rose 37.5 cents to close at $20.125 in moderate trading on the New York Stock Exchange.

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Within the last year, shares of South San Francisco-based Genentech have traded for as much as $46.50. But the stock fell sharply last fall after the company said it was temporarily halting production of Activase, also known as TPA, due to a slowdown in sales.

Genentech sought the FDA approval for competitive reasons. With Activase costing $2,300 per dose, emergency room physicians have been interested in administering a far less expensive competing drug, Streptokinase, which the FDA had already acknowledged as lifesaving for some patients.

Although sales of Activase got off to a fast start after its introduction in November, 1987--sales totaled $190 million in the first 12 months--the pace soon slowed. And the company reported sharply lower 1988 net income of $20.6 million due to a $23 million one-time charge for inventory of the drug that may become outdated before it is sold.

Genentech said the FDA decision to let it advertise Activase as lifesaving in some circumstances is based on data from two studies showing improved survival rates following heart attacks when the drug was given.

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In the primary study used by the FDA, the “Anglo-Scandinavian Study of Early Thrombosis,” mortality was reduced by one-quarter, to 7.2% of heart attack patients treated with Activase within five hours, compared to a 9.8% death rate among patients treated with a placebo.

Genentech said a second supporting study showed that giving Activase within five hours of a heart attack significantly reduced the death rate in the next 21 days to 3.7% of the total from 6.3%.

Other studies, however, have also shown similar results for other competing drugs, such as Streptokinase, made by Hoechst AG of West Germany, and Eminase, produced by Beecham Group PLC of Britain. Both drugs cost about one-tenth as much as Activase.


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