Genentech to Submit Product License Application in 1996 for Activase for Acute Ischemic Stroke; Phase III Study Results Reported in Today's NEJM for Activase.

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 13, 1995--Genentech, Inc. (NYSE:GNE) announced today plans to submit a Product License Application to the U.S. Food and Drug Administration in 1996 for Activase(R) (Alteplase, recombinant t-PA) for the treatment of patients suffering from acute ischemic stroke based on the results of a multi-year Phase III clinical study conducted by the National Institute of Neurological Disorders and Stroke (NINDS). The study was published today in The New England Journal of Medicine.

The study of 624 patients found that out of every 100 patients treated with Activase within three hours of symptom onset as compared to placebo, at least 11 more patients recovered at three months with no symptoms or minimal functional deficits in the Activase treatment arm. As measured by four functional neurological outcome scales, the study appeared to show statistically significant and consistently positive results in the treatment group. Selected acute ischemic stroke patients met the rigorous study entry criteria eligible for treatment of this study, including initiation of treatment within three hours of symptom onset and a CT scan to rule out hemorrhage.

The most serious side effect from this therapy was intracranial hemorrhage. There were significantly more hemorrhages within 36 hours of treatment among the Activase treated population (6.4 percent as compared to 0.6 percent in the placebo group). However, mortality differences at three months were not observed between the treatment groups (17 and 21 percent respectively).

Stroke is the number one cause of adult disability in America, with more than three million people living with the effects of stroke, and more than one million who are severely impaired. Annually, $30 billion is spent treating stroke victims; the average cost of treatment per patient for the first 90 days after a stroke is $15,000 and can go as high as $35,000. About 84 percent of all strokes are ischemic strokes caused by a blood clot stopping or diminishing blood flow to an area of the brain. Thus, ischemic stroke, or "brain attack," has the same physiological cause as an acute myocardial infarction, or heart attack.

"We are very encouraged with the results of the study. However, since submission to and subsequent review by the FDA has yet to occur, clinicians currently treating stroke patients should await the findings of this review process," said Barry M. Sherman, M.D., chief medical officer at Genentech.

"With respect to these results, we intend to work closely with the FDA so that the most good for patients has the potential to be achieved," explained Dr. Sherman. If approved by the FDA, U.S. stroke treatment patterns would need to change to accommodate the early diagnosis of acute ischemic stroke necessary for this therapy.

Activase is currently marketed in the United States for the treatment of heart attack and acute pulmonary embolism.

Genentech, Inc. is a leading 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.

CONTACT: Genentech, Inc.

Paul Laland, 301/571-4679 (Media)(Dec. 13)

415/225-2742 (Office)

Laura Leber, 415/225-5759

Lisa Brock, 301/493-6725 (IR)(Dec. 13)

415/225-1034 (Office)