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Phase 3 Trial Initiated to Evaluate Combination Therapy of Nexavar(R) and Tarceva(R) in Patients with Liver Cancer
Date:5/28/2009

(3,4) 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.(3)

Nexavar's Differentiated Mechanism

Nexavar, an oral anti-cancer therapy, is currently approved in more than 70 countries for liver cancer and in more than 80 countries for the treatment of patients with advanced kidney cancer. 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.

Nexavar, which is co-developed by Bayer Healthcare Pharmaceuticals and Onyx Pharmaceuticals, Inc., is being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including breast cancer, lung cancer, ovarian cancer, colorectal cancer, and as an adjuvant therapy for kidney cancer and liver cancer.

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first six weeks of therapy and treated as needed. Bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo. The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common adverse events reported with Nexavar in patients with unresectable HCC were diarrhea, fatigue, abdominal pain, weig
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SOURCE Bayer HealthCare Pharmaceuticals Inc.; OSI Pharmaceuticals; Onyx Pharmaceuticals, Inc.
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