To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Retavase Clot-Busting Drug Available Nationwide URL: http://www.pslgroup.com/dg/FB62.htm Doctor's Guide January 6, 1997
GAITHERSBURG, Md.-- Jan. 6, 1997-- Retavase(TM) (Reteplase, recombinant) To Be Co-Promoted With DuPont Merck in the U.S. -- Boehringer Mannheim Corporation, Therapeutics Division, and DuPont Merck announced today that Retavase, a thrombolytic agent cleared for marketing by the FDA in October, 1996, is now available for doctors' use nationwide. The companies have entered into an agreement to co-promote the new blood clot busting product, which is expected to help treat the 1.5 million American patients suffering from heart attack each year. A biotechnology product of Boehringer Mannheim GmbH research, Retavase was developed and is being manufactured at Boehringer Mannheim, Penzberg, Germany, one of the largest, state-of-the-art biotechnology facilities in Europe. Retavase is distributed by Boehringer Mannheim Corporation, Therapeutics Division. An international study of more than 6,000 patients treated with either Retavase or Streptokinase proved Retavase to be safe and effective in reducing mortality and lowering the incidence of CHF and other cardiovascular conditions(1). However, like all thrombolytics, Retavase(TM) (Reteplase, recombinant) does increase the risk of bleeding. In clinical trials, Retavase restored blood flow in significantly more patients after 90 minutes than Alteplase(2,3). In another patient group measuring blood flow at 60 minutes, Retavase also restored blood flow in significantly more patients than Alteplase. The correlation between patency and patient outcome has not been established. The angiographic trials were not designed or powered to compare Retavase and Alteplase with respect to outcome of mortality or stroke. Consequently, comparison of mortality and stroke cannot be made. Retavase is the only thrombolytic that can be administered in a simple two-shot form rather than a continuous intravenous infusion. Thrombolytic agents are used to treat patients who suffer from heart attack, or what is medically known as acute myocardial infarction (AMI). Widespread research has shown that one of the most effective treatments for a heart attack as a result of blockage caused by a blood clot is to quickly administer a thrombolytic agent to restore blood flow to the affected artery. "Retavase represents a major advance in improving AMI management," said Daniel Odenheimer, Ph.D., director of clinical research, Boehringer Mannheim Corporation, Therapeutics Division. "Retavase will give physicians a new resource with demonstrated clinical benefits to improve the outlook for millions of people suffering from heart attack each year." "We believe that Retavase(TM) (Reteplase, recombinant) is an important life-saving introduction -- expanding the team of sales professionals for the product ensures immediate educational support and product stocking efforts that benefit hospitals, physicians and their patients," commented representatives from both companies. Boehringer Mannheim Corporation, Therapeutics Division (BMCT), a division of Indianapolis-based Boehringer Mannheim Corp., was established in Maryland in 1984 to focus on drug development. Establishing commercial operations in 1991, BMCT today employs more than 400 people and is headquartered in Gaithersburg, Maryland. Privately-held Boehringer Mannheim Group, founded in 1859, has divisions in biochemicals, diagnostics and therapeutics, which contributed $3.27 billion to the company's worldwide sales in 1995. The DuPont Merck Pharmaceutical Company is a worldwide, research-based pharmaceutical company. Formed in 1991 as a partnership between DuPont and Merck & Company, Inc., DuPont Merck is focused on research, development and delivery of pharmaceuticals to treat unmet medical needs in the fight against central nervous system disorders, heart disease, cancer, HIV and arthritis-related disorders. The company is also a leader in radiopharmaceuticals. (1) INJECT (International Joint Efficacy Comparison of Thrombolytics) Lancet 1995; 346:329-336 (2) (Alteplase) Activase(R) is a registered trademark of Genentech, Inc. (3) RAPID II (Reteplase and Alteplase Patency Investigation During Myocardial Infarction), Circulation 1996; 94:891-898. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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