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Bayer Temporarily Suspends Global Trasylol(R) Marketing
Date:11/5/2007

ved either aminocaproic acid or tranexamic acid. Bayer has been informed that data are now being collected from centers throughout Canada and a final data analysis will be undertaken by BART investigators -- a process that is expected to take up to eight weeks, or perhaps longer.

On October 25, 2007, Bayer posted additional guidance to physicians and health care providers regarding the use of Trasylol and BfArM, the FDA and other regulatory authorities posted health alerts and other communications in their respective markets. In the time since, the agencies have continued to work with Bayer to evaluate appropriate next steps. Given the limited and preliminary nature of the information available to date from the BART study, these are challenging and complex decisions.

To reiterate, once more complete information is available from BART investigators and a thorough evaluation can be conducted by Bayer and global health authorities, the company will communicate publicly regarding any further actions that may be undertaken in response to the analysis of that information. Over the next days, information concerning the temporary market suspension will be communicated to physicians, health care providers and hospital pharmacists in each respective market.

Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling.

First through third quarter estimated global 2007 revenue for Trasylol was euro 93 million, including approximately euro 63 million from the U.S. and euro 5 million in Germany.

Information regarding today's decision has been posted to Bayer's websites http://www.trasylol.com, http://www.pharma.bayer.com, http://www.bayerscheringpharma.de/trasyslol/en,

SOURCE Bayer HealthCare
Copyright©2007 PR Newswire.
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