Bayer AG - Stockholders' Newsletter Third Quarter 2007

Focus

Nexavar® approved in Europe to treat liver cancer

Leverkusen. Nexavar® recently became the first treatment for hepatocellular carcinoma, the most common form of liver cancer, to be approved in Europe. Studies show Nexavar® to significantly extend overall survival in patients with this disease.The European Commission has granted marketing authorization to Nexavar® (sorafenib) tablets for the treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.

New studies have shown that Nexavar® can significantly extend overall survival in patients with hepatocellular carcinoma. Our photo shows Bayer employee Gisela Niepraschk carrying out an inspection at the Nexavar® packaging plant in Leverkusen.

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New studies have shown that Nexavar® can significantly extend overall survival in patients with hepatocellular carcinoma. Our photo shows Bayer employee Gisela Niepraschk carrying out an inspection at the Nexavar® packaging plant in Leverkusen.

Nexavar®, an oral anti-cancer drug, is the first approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Additional regulatory filings in HCC are under review in countries around the world including the U.S. and, most recently, Japan. Nexavar® is currently approved in more than 60 countries for the treatment of patients with advanced kidney cancer and is being jointly developed by Bayer HealthCare and Onyx Pharmaceuticals, Inc.

“The approval of Nexavar, a novel multi-kinase inhibitor, represents an unprecedented advance for patients with HCC who, until now, had no approved systemic treatment options,” said Arthur J. Higgins, Chairman of the Executive Committee of Bayer HealthCare. “This milestone will likely establish Nexavar as the standard of care in HCC and shows the dedication of health authorities to make Nexavar available as quickly as possible. Most importantly, it allows us to offer patients and medical professionals the potential to improve treatment outcomes for this devastating disease.”

The European Commission’s decision to approve Nexavar® is based on positive data from the international, Phase III, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar® extended overall survival by 44 percent in patients with HCC versus placebo. The primary objective of the study was to compare overall survival in patients administered Nexavar® versus those administered placebo. Median overall survival was 10.7 months in Nexavar®-treated patients compared to 7.9 months in those taking placebo. There were no significant differences in serious adverse event rates between the Nexavar®- and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar® being diarrhea and hand-foot skin reaction. Based on these data, a supplemental New Drug Application for Nexavar® was granted Priority Review status by the U.S. Food and Drug Administration (FDA) in August. The regulatory filing in Japan was submitted recently.

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. Over 600,000 cases of liver cancer are diagnosed worldwide each year (about 54,000 in Europe, 19,000 in the U.S. and 390,000 in China, Korea and Japan), and incidence is increasing. Currently, the five-year survival rate for patients with liver cancer in Europe is less than 8 percent. Risk factors for the development of liver cancer include chronic infections with the hepatitis B or C virus.

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.

The product is currently used in more than 50 countries, including the United States and the European Union, for the treatment of patients with advanced kidney cancer. In Europe, Nexavar® is approved for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Nexavar® is also being evaluated by government institutions, oncology study groups and individual scientists as a single-agent or combination treatment in a wide range of other cancers, including adjuvant therapy for kidney cancers, metastatic melanoma, non-small-cell lung cancer and breast cancer.