BAYER AND ONYX COMPLETE FILING OF NDA FOR SORAFENIB

Bayer Pharmaceuticals and Onyx Pharmaceuticals announced that the companies have completed the submission of a New Drug Application (NDA) with the FDA for sorafenib (BAY 43-9006) for patients with advanced renal cell carcinoma, or kidney cancer.

Sorafenib was accepted by the FDA into the Pilot 1 Program for continuous marketing applications. The Pilot 1 Program was designed for therapies that have been granted fast-track status and have the potential to provide important therapeutic benefit over available therapies. Under the Pilot 1 Program designation, the FDA is committed to reviewing each "reviewable unit" of the submission within a six month timeframe.

The sorafenib submission is based on an ongoing Phase III trial in patients with advanced kidney cancer. Results from the study - the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer - were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).