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Nexavar Approved in Japan for the Treatment of Advanced Liver Cancer
Date:5/20/2009

- First and only oral targeted therapy to significantly improve overall survival in patients with the disease -

WAYNE, N.J. and EMERYVILLE, Calif., May 20 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Nexavar(R) (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that accounts for 95 percent of all liver cancer cases in Japan(1). Nexavar is also currently available in Japan as an approved treatment for unresectable or metastatic renal cell carcinoma (RCC).

The approval in Japan was based on the international, Phase 3 double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) study that evaluated more than 800 patients who received no prior systemic therapy. The study found that Nexavar improved overall survival in patients with HCC by 44 percent (HR=0.69; p=0.0006) versus placebo. Based on SHARP results, Nexavar is currently approved in more than 70 countries for liver cancer, including the U.S. and countries in Europe.

"Liver cancer is one of the leading causes of cancer-related deaths in Japan, and the incidence is continuing to rise," said Gunnar Riemann, member of the Executive Committee of Bayer HealthCare. "We are pleased with today's approval and what it may mean for liver cancer patients in Japan and their families who now have a therapy like Nexavar that has the potential to extend their lives."

In Japan, approximately 40,000 people are diagnosed with liver cancer each year and approximately 36,000 die from the disease, making primary liver cancer the third leading cause of cancer-related death in Japan.(2)

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SOURCE Bayer HealthCare Pharmaceuticals; Onyx Pharmaceuticals, Inc.
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