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www.fdanews.com/articles/61109-bayer-s-nexavar-approved-in-the-european-union

BAYER'S NEXAVAR APPROVED IN THE EUROPEAN UNION

July 24, 2006

The European Commission has granted marketing authorization to Bayer and Onyx Pharmaceuticals for Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, who have failed prior interferon-alpha or interleukin-2 based therapy, or when the patients are considered unsuitable for such therapy. Bayer will commercialize Nexavar in Europe.

Nexavar is being co-developed by Bayer and Onyx. The collaboration calls for Onyx to fund 50 percent of the development and marketing costs for Nexavar worldwide, except in Japan. In return, Onyx has a 50-50 profit share in the United States, where the companies co-promote the product. In all other countries, Bayer has exclusive marketing rights and Onyx's profit share is slightly less than 50 percent. In Japan, Bayer will fund product development and Onyx will receive a royalty.

The U.S. FDA approved Nexavar in December 2005, and it has since been approved in Switzerland, Mexico, Chile, Brazil and Korea.