Bayer HealthCare Pharmaceuticals Inc. announced today that the FDA has approved EOVIST(R) Injection, a gadolinium-based contrast agent, in T1-MRI of the liver.

Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the US Food and Drug Administration (FDA) has approved EOVIST(R) (Gadoxetate Disodium) Injection, a gadolinium-based contrast agent, for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease. The approval makes EOVIST the first organ-specific MRI contrast agent approved in the United States in more than a decade.

"The approval of EOVIST in the United States marks a significant achievement in advancing the accurate diagnosis of liver disease," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "This milestone demonstrates Bayer HealthCare Pharmaceuticals' commitment to providing innovative imaging products that can help improve the lives of patients."

EOVIST is a paramagnetic MRI contrast agent that combines features of both an extracellular contrast agent and a hepatocyte-specific agent. EOVIST is administered via an intravenous, bolus injection and has a dual route of excretion with approximately 50 per cent eliminated through the liver and 50 per cent eliminated through the kidney. Detection and characterization of malignant and benign focal liver lesions with EOVIST may help enhance diagnostic accuracy and increase diagnostic confidence.

"EOVIST-enhanced images can provide more comprehensive information about focal liver lesions in a single, short imaging session than was previously available," said Jeffrey Brown, MD, Professor of Radiology, Washington University School of Medicine, St. Louis. "With the availability of EOVIST, our ability to evaluate patients with benign and malignant focal hepatic lesions will 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.

[1] American Cancer Society. "What Are the Key Statistics About Liver Cancer?" Available at http://www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statisti cs_for_liver_cancer_25.asp?sitearea=. Last Accessed on 4/16/08.
[2] American Cancer Society. "Overview: Colon and Rectum Cancer: How Many People Get Colorectal Cancer?" Available at http://www.cancer.org/docroot/CRI/content/CRI_2_2_1X_How_Many_People_Get_Color ectal_Cancer.asp?sitearea=. Last Accessed, 5/16/08.