The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Li...( - Nexavar is First Approved Syste...),Health

- Nexavar is First Approved Systemic Therapy to Treat the Disease -

WAYNE, N.J. and EMERYVILLE, Calif., July 23 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that The New England Journal of Medicine published results of a Phase 3 trial demonstrating that Nexavar(R) (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo. This represents a 44 percent improvement in median overall survival for patients treated with Nexavar.

Based on the strength of these data, Nexavar was approved for HCC by the European Agency for the Evaluation of Medicinal Products (EMEA) and by the U.S. Food and Drug Administration (FDA) in October and November 2007, respectively.

"Despite advances in the management of many other cancers, liver cancer has remained a treatment challenge, due to a lack of systemic therapies to extend life and limited opportunity for surgical intervention," said Dr. Josep M. Llovet, co-principal investigator of the study and professor of research, Barcelona Clinic Liver Cancer (BCLC) Group, IDIBAPS, Liver Unit, Hospital Clinic Barcelona; director of research, HCC Program, associate professor of Medicine, Mount Sinai School of Medicine, New York. "This landmark study reflects a new systemic standard of care using Nexavar in the first-line management of liver cancer."

"The number of lives lost to liver cancer continues to increase globally, due to the prevalence of hepatitis B and C infections," said Jordi Bruix, co-principal investigator and director of the Barcelona Clinic Liver Cancer (BCLC) Group; senior consultant, Liver Unit, Hospital Clinic of Barcelona. "We are encouraged that there is a new treatment option available for liver cancer that has clearly demonstrated a survival benefit in this patient population."

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