Bayer, Onyx drug Nexavar approved in Switzerland to treat patients with kidney cancer

By E. Janene Geiss

Philadelphia, March 30 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. announced Thursday that the Swiss Agency for Therapeutic Products (Swissmedic) has approved Nexavar (sorafenib) tablets for the treatment of patients with advanced renal cell carcinoma, or kidney cancer, after nepherectomy and prior palliative or adjuvant therapy with cytokines (IL-2, IFN).

Nexavar, which has been shown to double progression-free survival in patients with advanced renal cell carcinoma, will be marketed by Bayer in Switzerland, according to a company news release.

"The approval of Nexavar in Switzerland marks an important step in the brand's entry into Europe," Gunnar Riemann, head of Bayer HealthCare's pharmaceuticals division, said in the release.

Nexavar was approved by the Food and Drug Administration in December 2005. In September 2005, Bayer filed for regulatory approval with the European Medicines Agency. Pending a favorable review, market availability is possible in the E.U. countries in the second half of 2006.

Bayer said it also has completed filings in several countries, including Mexico, Australia, Brazil, Canada and Turkey.

Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor growth and tumor blood supply - two important cancer growth activities.

Nexavar is being co-developed by Bayer and Onyx. The co-development collaboration calls for Onyx to fund 50% 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%. In Japan, Bayer will fund product development, and Onyx will receive a royalty.

Onyx is a West Haven, Conn., pharmaceutical company that develops novel cancer therapies that target the molecular basis of cancer.

Bayer Pharmaceuticals, based in Emeryville, Calif., is part of the operations of pharmaceutical and health care company Bayer HealthCare AG, a subsidiary of Bayer AG.

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