BAYER YAKUHIN SUBMITS APPLICATION TO MARKET NEXAVAR

Japan-based Bayer Yakuhin has submitted a marketing application of an orally available anticancer drug, Nexavar (sorafenib) for the treatment of advanced renal cell carcinoma (RCC), which was developed by Bayer HealthCare AG and Onyx Pharmaceuticals, to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Nexavar was approved by the U.S. FDA in December 2005. It has also been approved by the regulatory authorities of Switzerland, Mexico, Chile, Brazil and South Korea. In the EU, an application was submitted to the EMEA in September 2005.

Nexavar has been shown to suppress cancer growth by stopping the signaling cascade for proliferation of tumor cells and inhibiting angiogenesis.