In Japan Bayer received approval for Nexavar (sorafenib) tablets for the treatment of unresectable hepatocellular carcinoma (HCC) from the Ministry of Health, Labour and Welfare (MHLW). Nexavar, an oral anti-cancer drug, jointly developed by Bayer HealthCare AG and Onyx Pharmaceuticals Inc, is the only drug therapy shown to significantly improve overall survival in patients with the disease. The product is already marketed in Japan as a therapy for unresectable or metastatic renal cell carcinoma (RCC).

"Liver cancer is one of the leading causes of cancer-related deaths in Japan, and the incidence is continuing to rise," said Gunnar Riemann, member of the executive committee of Bayer HealthCare. "We expect that this approval will provide patients a new option for improved treatment and we are pleased that with our MRI liver contrast agent Primovist we contribute to early diagnosis of HCC. We will make further efforts to contribute to patients and medical experts both in fields of diagnosis and treatment of HCC in Japan and worldwide."

In Japan, approximately 40,000 people are diagnosed with liver cancer each year and approximately 36,000 people die from the disease, making primary liver cancer the third leading cause of cancer-related death in Japan. Hepatitis B viral infection (HBV) as well as hepatitis C viral infection (HCV) are leading risk factors for developing liver cancer worldwide, with HCV being the primary risk factor in Japan. An estimated 80 to 90 per cent of Japanese patients diagnosed with liver cancer have HCV.

The MHLW's decision is based on positive data from the international, phase-III, double-blind placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial that evaluated more than 600 patients who received no prior systemic therapy. The study found that Nexavar extended overall survival by 44 percent in patients with HCC versus placebo. Based on these data, Nexavar was approved to date in more than 70 countries for liver cancer, including the US and Europe.

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.