Primovist® approved in the U.S. for the Detection and Characterization of Liver Lesions

Berlin, July 2008 – The U.S. Food and Drug Administration (FDA) has approved Bayer Schering Pharma’s magnetic resonance imaging (MRI) contrast agent Primovist® (gadoxetate disodium) for the detection and characterization of liver lesions in adults with known or suspected focal liver disease. The product will be marketed in the United States under the name EOVIST®; it is currently marketed as Primovist outside the U.S. and as EOB Primovist in Japan. It is the first organ-specific MRI contrast agent to be approved in the U.S. for over a decade. Bayer plans to make EOVIST available to customers in the U.S. in the summer of 2008.

“Primovist not only offers the unique benefit of being able to simultaneously detect, locate and distinguish various types of liver lesions, but also helps to guide and follow-up on treatment decisions, as it enables radiologists to identify even tiny pathological liver lesions,” said Dr. Gunnar Riemann, Member of the Board of Management of Bayer Schering Pharma AG, responsible for the company’s Business Units. “Bayer is now in the unique position of offering Primovist for diagnosing patients with liver cancer and Nexavar for treating hepatocellular carcinoma – the most common form of liver cancer.”

Using Primovist for the early detection, localization and definition of the exact lesion type (characterization) of malignant and benign focal liver lesions enhances diagnostic accuracy and increases diagnostic confidence. The contrast agent combines liver-specific imaging capabilities within a rapidly eliminated and well-tolerated compound. It is administered by intravenous injection. Primovist has a dual route of excretion: approximately 50 percent is eliminated through the liver, 50 percent through the kidney.

Primovist’s mode of action has several distinctive features compared to existing contrast agents. It improves the detection of liver lesions during the liver-cell specific imaging phase and thus enables an early diagnosis of liver diseases such as hepatocellular carcinoma (HCC). Furthermore, the precise image contrast achieved with Primovist allows a clear delineation of structures, such as tumors and intrahepatic vessels. By combining early dynamic and hepatocyte-phase imaging, Primovist-enhanced MRI helps to characterize and clearly localize liver tumors and can act as a guide for surgical planning.

Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 15,000 cases of liver cancer are diagnosed every year in the United States and the incidence is increasing. Earlier staging of primary tumors with metastases in the liver, such as colon cancer, may improve treatment decisions and hence the survival rate. Approximately 510,000 new cases of colon cancer are diagnosed every year globally, more than 200,000 patients per year die at a late stage of colon cancer.

Primovist was first approved in Europe in 2004 followed by Japan in 2007; it is registered in more than 40 countries.