Bayer and Onyx Submit Marketing Authorization Application for Sorafenib in the European Union

Bayer Pharmaceuticals Corp. has submitted a Marketing Authorization Application to the European Medicines Agency for the approval of sorafenib in the treatment of advanced Renal Cell Carcinoma, also known as kidney cancer. This application is part of the companies' efforts to make the anti-cancer drug candidate available to doctors and patients in the European Union. In addition to the EU application, Bayer and Onyx have also completed the submission of a New Drug Application to the U.S. Food and Drug Administration in July 2005. The applications are based on an ongoing phase III trial in patients with advanced kidney cancer, which presented results in May at the 41st Annual Meeting of the American Society of Clinical Oncology. Sorafenib is being codeveloped by Bayer and Onyx, with Onyx funding 50% of the development and marketing costs worldwide, except in Japan.

Key Takeaways:

• Bayer has submitted a Marketing Authorization Application to the European Medicines Agency for sorafenib in the treatment of advanced Renal Cell Carcinoma.
• The application is part of the companies' efforts to make sorafenib available to doctors and patients in the European Union.
• Bayer and Onyx have completed the submission of a New Drug Application to the U.S. Food and Drug Administration in July 2005.
• The applications are based on an ongoing phase III trial in patients with advanced kidney cancer.
• The trial presented results in May at the 41st Annual Meeting of the American Society of Clinical Oncology.
• Sorafenib is being codeveloped by Bayer and Onyx, with Onyx funding 50% of the development and marketing costs worldwide, except in Japan.
• The codevelopment collaboration calls for Onyx to have a 50/50 profit share in the United States, and a royalty in Japan.
• Sorfenib targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature, and has shown promising results in preclinical models.

Statistics:

• 11 EU countries will participate in the European Advanced Renal Cell Carcinoma Sorafenib (EU ARCCS) study.
• The study will be managed by Bayer and will begin this fall.
• 50% of the development and marketing costs for sorafenib worldwide will be funded by Onyx.
• 50/50 profit share for sorafenib in the United States.
• Onyx will receive a royalty for sorafenib in Japan.

Sources:

• Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc., press release, submitted to the European Medicines Agency (EMA)
• U.S. Food and Drug Administration (FDA) New Drug Application (NDA) submitted by Bayer and Onyx in July 2005
• American Society of Clinical Oncology (ASCO) 41st Annual Meeting, May 2005
• Science Letter editors, Science Letter via NewsRx.com, Copyright 2005