The Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN), Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. announced here. Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in Switzerland.
"The approval of Nexavar in Switzerland marks an important step in the brand's entry into Europe. We are pleased with the decision by Swissmedic, and proud that we can now make this therapy available to physicians and patients in this region," said Dr. Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division.
Nexavar was approved by the US FDA in December 2005. In September 2005, Bayer filed for regulatory approval with the European Medicines Agency (EMEA). Pending a favourable review, market availability is possible in the EU countries in the second half of 2006. In addition, Bayer has completed filings in several countries, including Mexico, Australia, Brazil, Canada, and Turkey, says the release.
Nexavar is being co-developed by Bayer and Onyx. The co-development 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 (except Japan) 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.