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Bayer And Onyx Report Phase 3 Study Results Of NEXAVARA® (sorafenib) As Adjuvant Treatment For Patients With Liver Cancer Who Have Undergone Surgery Or Local Ablation

WHIPPANY, N.J., THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., March 11, 2014 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR ® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. The safety findings were consistent with the known profile of sorafenib.  Data from this study will be submitted for presentation at an upcoming scientific congress.

"While the primary endpoint of this adjuvant trial was not met, Bayer and Onyx remain dedicated to ongoing research in all stages of liver cancer," said Pamela A. Cyrus, M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "The outcome announced today does not affect the currently approved indications. NEXAVAR is approved for the treatment of patients with unresectable liver cancer."

Full prescribing information for NEXAVAR is available at www.NEXAVAR-us.com.

About the STORM TrialThe Phase 3, randomized, double-blind, placebo-controlled STORM ( S orafenib as Adjuvant T reatment in the Prevention o f R ecurrence of Hepatocellular Carcino m a) trial is an international multicenter study that evaluated clinical benefit of sorafenib versus placebo as an adjuvant treatment in patients with HCC following potential curative treatment (surgical resection or local ablation).  The primary endpoint of the study was recurrence-free survival (i.e., the length of time that a patient survives without recurrence of HCC).  Secondary endpoints included time to recurrence of HCC (intrahepatic and extrahepatic) and overall survival.  Safety and tolerability were also assessed. The trial included approximately 1,100 patients who were randomized to receive 400 mg of sorafenib twice daily or matching placebo for four years or until disease recurrence, whichever occurred first.

About Liver CancerHepatocellular carcinoma is the most common form of liver cancer and is responsible for about 80 percent of the primary malignant liver tumors in adults. 1,2  Liver cancer is the sixth most common cancer in the world and is the second most common cause of death from cancer worldwide.  More than 780,000 cases of liver cancer are diagnosed worldwide each year (more than 395,000 in China, 52,000 in the European Union and 30,000 in the United States) and the incidence is increasing.  In 2012, approximately 746,000 people died of liver cancer including approximately 383,000 in China, 48,000 in the European Union and 24,000 in the United States. 3

About NEXAVAR ® (sorafenib) TabletsNEXAVAR is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. NEXAVAR is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, NEXAVAR has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

NEXAVAR is currently approved in more than 100 countries. NEXAVAR is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

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