Thursday, Jun 6, 1996
South San Francisco, Calif. -- June 6, 1996 --Genentech, Inc. (NYSE: GNE) today announced that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended by unanimous vote that Activase® (Alteplase, recombinant), the company's clot-dissolving drug, be approved for the treatment of eligible patients suffering from acute ischemic stroke within three hours of symptom onset. The recommendation is based on results of a nationwide Phase III clinical study conducted by the National Institute of Neurological Disorders and Stroke (NINDS) that was published in The New England Journal of Medicine on December 14, 1995.
"We are extremely pleased with today's recommendation, as it brings us one step closer to providing new hope to stroke victims, who, previously, have had no acute medical interventions available to help minimize the devastating disability of stroke," said Arthur D. Levinson, Ph.D., Genentech president and chief executive officer. "We have worked closely with NINDS investigators and the FDA and hope formal marketing clearance of the committee recommendation will soon follow."
More than three million Americans currently are living with the effects of stroke, costing our nation an estimated $30 billion in medical bills and lost productivity annually. Approximately 80 percent of all strokes are "ischemic," 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. Activase, if cleared by the FDA, is expected to be suitable for use in many of the ischemic stroke population presenting within three hours of symptom onset.
Activase currently is marketed in the United States for the treatment of heart attack and acute massive 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.
MEDIA CONTACT: Paul Laland (415) 225-2742
INVESTOR CONTACT: Diane Schrick (415) 225-1599
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