Monday, Mar 17, 1997
South San Francisco, Calif. -- March 17, 1997 --Results from the GUSTO III study, announced at the American College of Cardiology annual meeting, demonstrated that a new thrombolytic agent, Retavase® (reteplase) does not save more lives than Genentech, Inc.'s (NYSE:GNE) Activase® (Alteplase, a recombinant tissue plasminogen activator, t-PA, for the treatment of acute myocardial infarction [AMI]).
Investigators of the GUSTO group reported that in the trial, Retavase, a thrombolytic marketed by Boehringer Mannheim, did not provide a statistically significant benefit in 30-day mortality as compared to Activase. In the trial, 10,139 patients received Retavase while 4,921 patients were given Activase.
Genentech Vice President of Clinical Research, David Stump, MD, commented on the trial. "The primary hypothesis, as established by the investigators, was to determine if Retavase would save more lives than Activase. Since this primary hypothesis was not proven, Activase remains a standard of care in the management of AMI. We believe there is no reason for physicians to change their prescribing habits."
The overall mortality rate for Retavase was 7.43 percent as compared to 7.22 percent with Activase. Total intracranial hemorrhage rate for Retavase was 0.91 percent and 0.88 percent for Activase. Total stroke rates were 1.67 percent and 1.83 percent, respectively.
"For the past 10 years, physicians have used Activase to save the lives of heart attack patients. In 1996, Activase was also the first therapy cleared by the U.S. Food & Drug Administration for the treatment of acute ischemic stroke. Its importance to cardiovascular medicine is enormous and GUSTO III reinforces the role Activase plays in saving lives every day," Dr. Stump said.
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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