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Nexavar Approved in Japan for the Treatment of Advanced Liver Cancer
Date:5/20/2009

titis B viral infection (HBV) and hepatitis C viral infection (HCV) are leading risk factors for developing primary liver cancer worldwide, with HCV being the primary risk factor in Japan. An estimated 80 to 90 percent of Japanese patients diagnosed with liver cancer have HCV.(3)

"This is a significant milestone in the Japanese region where patients, who have high rates of liver cancer, are truly in need of a treatment option that improves survival," said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals, Inc. "This latest approval provides further evidence that Nexavar is an important therapy for patients with liver cancer as well as kidney cancer, an indication for which Nexavar was first approved in Japan."

Hepatocellular carcinoma is the most common form of liver cancer(4) and is responsible for about 90 percent of the primary malignant liver tumors in adults(5). Liver cancer is the sixth most common cancer in the world(6) and the third leading cause of cancer-related deaths globally(7). More than 600,000 cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing(4). In 2002, approximately 600,000 people died of liver cancer including approximately 370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States(4).

Nexavar's Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also demonstrat
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SOURCE Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals, Inc.
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