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Nexavar Significantly Extend Survival for Patients with Advanced Liver Cancer

Trial to be Stopped Early Based on Positive Outcome

Feb. 12, 2007

Bayer Pharmaceuticals (BAY) and Onyx Pharmaceuticals, (ONXX):  The independent data monitoring committee (DMC), which has  reviewed the safety and efficacy data from the firms’ pivotal Phase 3 trial in patients with advanced hepatocellular carcinoma (HCC), or primary liver cancer concluded that the trial met its primary endpoint resulting in superior overall survival (OS) in those patients receiving Nexavar® (sorafenib) tablets versus those patients receiving placebo. No demonstrated difference in serious adverse event rates between the two treatment arms (Nexavar and placebo).

Based on these conclusions, the DMC recommended that the trial be stopped early.

Bayer and Onyx believe that no more trials are needed, so they decided to stop the trials and allow all patients enrolled in this trial access to Nexavar. This news is important for those patients who suffer from advanced hepatocellular carcinoma (HCC), as these patients have very limited approved systemic treatments for this disease. The scarcity of effective treatments led the developing firms to continue discussions with health authorities worldwide, including the FDA and European health authorities regarding the next steps in filing for approval for the treatment of HCC. Following these discussions, the companies will proceed to file as rapidly as possible. The two companies also reported that they plan to submit the results from the trial to the American Society of Clinical Oncology (ASCO), for presentation at its annual meeting, June 1-5, 2007.

THE DRUG

Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted 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 demonstrated that Raf/MEK/ERK has a role in nepatocellular carcinoma (HCC), therefore blocking signaling through Raf-1 may offer therapeutic benefits in HCC.

Nexavar is currently approved in nearly 50 countries, including the United States and in the European Union, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated by the companies, international study groups, government agencies or individual investigators as a single agent or combination treatment in a wide range of cancers, including adjuvant renal cell carcinoma (RCC), advanced liver cancer, metastatic melanoma, non-small cell lung cancer and breast cancer.

THE TRIAL

This analysis was conducted using data from the Sorafenib HCC Assessment Randomized Protocol (SHARP) Trial, an international Phase 3 double-blind, randomized, placebo-controlled trial designed to evaluate Nexavar in patients with advanced HCC, or primary liver cancer, who had no prior systemic therapy. Six hundred and two patients were randomized and enrolled at sites in the Americas, Europe, and Australia/New Zealand. The primary objectives of the study are to compare OS and time to symptom progression (TTSP) in patients administered Nexavar versus those patients administered placebo.

Hepatocellular carcinoma, also known as primary liver cancer, is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world.

Important Safety Considerations for U.S. Patients Taking Nexavar

Based on the currently approved package insert for the treatment of patients with advanced kidney cancer, 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. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered.

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