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Bayer Yakuhin Files Anti-cancer Drug Nexavar(R) for the Treatment of Advanced Renal Cell Carcinoma.

Tokyo, Japan, June 29, 2006 - (JCN) - Today, Bayer Yakuhin Ltd. submitted a marketing application of an orally available anti-cancer drug, Nexavar(R) (sorafenib, BAY 43-9006) 200 mg tablet for the treatment of Advanced Renal Cell Carcinoma (RCC), which was developed by Bayer HealthCare AG (Germany) and Onyx Pharmaceuticals, Inc. (USA), to the Pharmaceuticals and Medical Devises Agency (PMDA) in Japan. Nexavar(R) was approved by FDA in December 2005 for the first time in the world and is now on the US market. Also it was approved by the regulatory authorities of Switzerland, Mexico, Chile, Brazil and South Korea. In EU, the application was submitted to EMEA in September 2005.

Nexavar(R) is a drug to suppress cancer growth by stopping the signalling cascade for proliferation of tumor cells and inhibiting angiogenesis which generates vessels to the newly proliferated tumor cells. In ASCO 2005, a prolongation of progression-free survival period was presented using the data of global Phase III which more than 900 RCC patients joined. According to that, time to progression or death on placebo group was 84 days, whereas it was 167 days (p<0.000001) on the group treated by Nexavar(R). In ASCO 2006 held in this June, an interim data on the overall survival was presented to show positive results of Nexavar(R).

In Japan, clinical trials of Nexavar(R) for the treatment of RCC started in 2002 and preferable data to support the efficacy and safety of Nexavar(R) was obtained to file today.

Once approved, it will be commercialized as Nexavar(R) in Japan as well. The registration of this product name was already accepted as a trademark in Japan.

Refer the URL below to know about Renal Cell Carcinoma in detail.

http://www.ncc.go.jp/jp/ncc-cis/pub/cancer/010243.html

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Publication:JCNN News Summaries
Geographic Code:9JAPA
Date:Jun 30, 2006
Words:310
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