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FDA Approves EOVIST(R) to Detect and Characterize Focal Liver Lesions
Date:7/8/2008

be improved."

The American Cancer Society estimates that 21,370 new cases of primary liver cancer and intrahepatic bile duct cancer will be diagnosed in the United States during 2008, and the incidence of liver cancer continues to increase.(1) Earlier staging of primary tumors with metastases in the liver, such as colon cancer, may improve treatment decisions and, hence, the survival rate. This year, approximately 110,000 new cases of colon cancer will be diagnosed in the United States.(2)

Stefanelli continued, "With EOVIST and Nexavar, Bayer HealthCare Pharmaceuticals is uniquely positioned to help healthcare professionals detect and treat liver cancer." Nexavar(R) (sorafenib), an oral anticancer medicine called a kinase inhibitor, is approved for use in patients with unresectable hepatocellular carcinoma (HCC).

EOVIST is marketed by Bayer HealthCare affiliates outside the United States as Primovist and in Japan as EOB Primovist. It was first approved in 2004 in Europe, and with this FDA approval, is now approved in more than 40 countries.

Clinical Trials Summary

Eight-hundred sixteen (816) patients with suspected or known focal liver lesions were enrolled in two of four non-randomized, intrapatient-controlled studies that evaluated predominantly the detection (Studies one and two) or morphological characterization (Studies three and four) of liver lesions. Studies one and two ("detection" studies) enrolled patients who were scheduled for liver surgery. MRI results were compared to a reference standard that consisted of surgical histopathology and the results from intra-operative ultrasound of the liver. The studies assessed the sensitivity of pre-contrast MRI and EOVIST-contrasted MRI for the detection of liver lesions when each set of images was compared to the reference.

Studies three and four ("characterization" studies) enrolled patients with known or suspected focal liver lesions, including patients who were not sched
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SOURCE Bayer HealthCare Pharmaceuticals Inc.
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