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New Analyses Confirm Nexavar's Efficacy and Safety in Multiple Patient Subsets With Liver Cancer
Date:10/31/2008

- Subanalyses from the Phase 3 SHARP and Asia-Pacific trials to be presented at 59th Annual Meeting of the American Association for the Study

of Liver Diseases -

WAYNE, N.J. and EMERYVILLE, Calif., Oct. 31 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that new Nexavar data will be presented at the upcoming 59th Annual Meeting of the American Association for the Study of Live Diseases (AASLD) demonstrating the clinical application of Nexavar(R) (sorafenib) tablets in multiple patient subsets with hepatocellular carcinoma (HCC), or liver cancer. Nexavar is the only systemic treatment to demonstrate prolonged overall survival in unresectable HCC and is currently approved in more than 60 countries for the treatment of the disease.

Data will be presented evaluating specific patient subpopulations from the Phase 3 SHARP (Sorafenib HCC Assessment Randomized Protocol) and Asia Pacific trials. The trials enrolled 602 and 226 patients, respectively, with advanced, unresectable HCC who had not received prior systemic therapy. Patients in both studies were randomized to receive either Nexavar 400 mg twice daily or placebo. Data from both Phase 3 trials demonstrated that patients treated with Nexavar experienced a significant improvement in overall survival; 44% (HR=0.69; p-value=0.0006) in the SHARP trial and 47% (HR=0.68; p-value=0.014) in the Asia Pacific trial.

"The SHARP and Asia Pacific trials continue to increase our understanding and provide clinical confirmation of the efficacy, safety and clinical benefit of Nexavar in patients with liver cancer," said Mark Gelder, MD, vice president, Therapeutic Area Oncology
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SOURCE Bayer HealthCare Pharmaceuticals, Inc.; OnyxPharmaceuticals, Inc.
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