Schering Deutschland GmbH

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PTK/ZK CONFIRM 1 Phase III Study Shows Positive Drug Effects in Metastatic Colorectal Cancer - Filing Now Anticipated for Early 2007

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21.03.2005

Schering AG announced today that the analysis of progression free survival (PFS) as assessed by central radiology review in the CONFIRM 1 trial with the investigational drug PTK/ZK based on information obtained after trading hours on March 18, 2005 did not achieve statistical significance. However, a separate pre-planned analysis of progression-free survival as assessed by the investigators achieved statistical significance.

Further analysis of the data including more detailed evaluations of subpopulations are ongoing to fully assess the potential benefit of PTK/ZK.

Based on a review of the CONFIRM 1 results, an independent data monitoring board recommended the phase III clinical trial program to continue to allow analysis of overall survival endpoints. This is expected in the second half of 2006.

Another ongoing phase III trial, CONFIRM 2, compares the PTK/ZK combination regimen to FOLFOX-4 alone in patients with metastatic colorectal cancer who have progressed after irinotecan-based chemotherapy. An interim analysis is planned in mid 2005 and final overall survival data are expected in mid 2006.

Filing for approval with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) is now anticipated in early 2007.

end of announcement                                euro adhoc 21.03.2005 05:30:00
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Further inquiry note: Oliver Renner Head Corporate Business Communication Tel.:  +49 (0)30 468 12431 Fax: +49 (0)30 468 16646 E-Mail: oliver.renner@schering.de

Branche: Pharmaceuticals
ISIN:      DE0007172009
WKN:        717200
Index:    DAX, Prime Standard, CDAX, HDAX, Prime All Share
Börsen:  Baden-Württembergische Wertpapierbörse / regulated dealing
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              New York / ADR
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              Börse Düsseldorf / official dealing
              Bayerische Börse / official dealing
              Bremer Wertpapierbörse (BWB) / official dealing



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