Tuesday, Mar 19, 1996
South San Francisco, Calif. -- March 19, 1996 --Genentech, Inc. (NYSE: GNE) announced today the submission of a supplemental Product License Application (PLA) to the U.S. Food and Drug Administration (FDA) for Activase® (Alteplase, recombinant t-PA) for the treatment of acute ischemic stroke within three hours of symptom onset. The submission is based on the results of a multi-year Phase III clinical study conducted by the National Institute of Neurological Disorders and Stroke (NINDS). The results of the study were published in The New England Journal of Medicine in December, 1995.
"As a result of a very productive partnership with NINDS and the FDA, we have, in a very rapid timeframe, submitted a product license application supplement for a medical condition that currently has no treatment available," said Arthur D. Levinson, Ph.D., Genentech president and CEO.
More than three million Americans are living with the effects of stroke, costing our nation more than $40 billion (medical bills and lost productivity) annually. Approximately 75 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. Activase, if cleared by the FDA, is expected to be used in some portion of the ischemic stroke population.
Activase is currently 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.
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