TOKYO - For the third time in a week Bayer released positive news related to Japan, saying Jan. 28 it had received marketing approval from the Ministry of Health, Labor and Welfare for Nexavar (sorafenib) for the treatment of advanced renal cell carcinoma. Four days earlier, the German company had said Nexavar received priority review from MHLW for the treatment of hepatocelluar carcinoma, a larger potential market.

In its third piece of good news, Bayer also said Jan. 24 that it had received Japanese approval for the contrast agent Primovist (gadoexetic acid disodium) for magnetic resonance imaging of the liver.

Nexavar, an oral multi-kinase inhibitor, is the first targeted therapy approved for metastatic RCC in Japan, providing Bayer with a leg up in that market on competitors Pfizer ( Sutent ) and Wyeth ( Torisel ). In Japan, roughly 10,000 patients suffer from kidney cancer, 80 percent to 85 percent of whom are diagnosed with RCC, according to Bayer. The biologic will go on sale after final listing on Japan's National Health Insurance drug reimbursement price list.

However, it is the priority review for the liver cancer indication that could prove a real boon for Bayer. Japan has the second largest population of liver cancer patients in the world, and 36,000 Japanese patients die annually from HCC, according to the company.

Nexavar is co-developed worldwide by Bayer and Emeryville, Calif.-based Onyx Pharmaceuticals. In Japan, Bayer is responsible for funding all product development and marketing costs, and will pay Onyx a royalty on sales. Bayer filed the RCC indication with MHLW in June 2006; the HCC indication was filed in September 2007.

Last August, Bayer and Onyx halted a Phase III trial of Nexavar in Asia-Pacific patients with HCC based on positive study results and on the recommendation of an independent data monitoring committee (Also see "Nexavar Survival Study In Asia-Pacific Patients With Liver Cancer Halted Early" - Scrip, 28 August, 2007.). Nexavar is the first drug shown to significantly improve overall survival in HCC patients, according to the companies.

For HCC, sorafenib is approved in more than 30 countries, including the U.S. and European Union. It is approved in more than 60 countries for RCC, including the U.S., EU and now Japan.

- Joshua Berlin (j.berlin@elsevier.com)

Banner Week For Bayer In Japan

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