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Nexavar Significantly Extends Overall Survival by 44% in Liver,Cancer Patients

rse events in patients receiving Nexavar being diarrhea and hand-foot-skin reaction. Based on the strength of the data, the companies are now in the process of preparing applications to the U.S. Food and Drug Administration (FDA) and European health authorities for a supplemental indication for Nexavar in treatment of patients with liver cancer.

"Although much progress has been made in cancer research, the number of lives lost to liver cancer is increasing," said Dr. Jordi Bruix, co-principal investigator and Director of the Barcelona Clinic Liver Cancer (BCLC) Group; Senior Consultant, Liver Unit, Hospital Clinic of Barcelona. "For that reason, these results represent an unprecedented achievement and Nexavar could become the first widely-approved new therapy for this difficult to treat cancer."

Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults.(1,2) It is the fifth most common cancer in the world(3) and the third leading cause of cancer-related deaths globally.(4) Over 600,000 new cases of HCC are diagnosed globally each year(4) (19,000 in the United States(5) and 32,000 in the European Union(6)), and in 2002 approximately 600,000 people (about 13,000 Americans and 57,000 Europeans) died of HCC.(7) Although overall cancer incidence and mortality are decreasing in the United States, both the incidence and mortality of liver cancer are increasing.(8)

Nexavar's Differentiated Mechanism

Nexavar targets both the tumor cell and tumor vasculature and is the only oral multi-kinase inhibitor that does not require patients to interrupt their treatment schedule.

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-
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