Monday, Aug 2, 1999
South San Francisco, Calif. -- August 2, 1999 --Genentech, Inc. (NYSE: DNA) today announced that this past Friday the company submitted for review by the U.S. Food and Drug Administration (FDA) a Biologics License Application (BLA) for Tenecteplase to be used in treating heart attack patients.
"We are extremely pleased that our efforts to develop a new thrombolytic -- with the convenience of a single bolus injection -- have resulted in filing a BLA with the FDA," said Arthur D. Levinson, Ph.D., president and chief executive officer at Genentech. "Clinical data provide us with scientific evidence that Genentech's design of Tenecteplase has great promise in the treatment of heart attacks."
Preliminary Phase III results of the ASSENT II (ASsessment of the Safety and Efficacy of a New Thrombolytic agent) trial, a 17,000-patient study, were presented in March of this year at the American College of Cardiology meeting.
With more than 1,000 sites in 29 countries, ASSENT II was designed as a randomized, double-blind, parallel group trial of a weight-adjusted, 30-50 mg single bolus of Tenecteplase versus the 90 minute accelerated infusion of Activase® (Alteplase, recombinant) in acute myocardial infarction (AMI) patients.
A bio-engineered plasminogen activator, Tenecteplase is similar to Activase, which is a recombinant version of naturally-occurring tissue plasminogen activator (t-PA), both dissolving blood clots causing heart attacks. Tenecteplase has been specifically designed to have a prolonged half-life, increased specificity for fibrin (a key component in an intracoronary clots) and increased resistance to plasminogen activator inhibitor-1 (PAI-1) -- a protein that can interfere with clot-dissolving effects of both naturally-occurring and recombinant t-PA during a heart attack.
Boehringer Ingelheim, co-sponsor of the ASSENT II study, is Genentech's developmental collaborator for Tenecteplase and international marketing partner for Alteplase. Boehringer Ingelheim plans to file a marketing application with the European Regulatory Authorities in September.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufacturers and markets human pharmaceuticals for significant unmet medical needs. Twelve of the approved products of biotechnology stem from Genentech science, seven of which Genentech markets directly in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
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