Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the State Food and Drug Administration (SFDA) of China has approved Nexavar® (sorafenib) tablets for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first systemic therapy for HCC patients in China and the only treatment to significantly improve overall survival in patients with the disease.
The approval was based on two international double-blind, placebo-controlled Phase 3 trials that evaluated more than 800 patients who received no prior systemic therapy.
"China has the highest number of liver cancer patients worldwide with more than 340,000 new cases diagnosed each year and the incidence is continuing to rise," said Gunnar Riemann, PhD, member of the Executive Committee of Bayer HealthCare. "We are proud to be at the forefront of liver cancer treatment with Nexavar and are hopeful that patients in China can potentially have their lives extended by treatment with Nexavar."
"This is another significant milestone in a region where patients are in dire need of a therapy that improves survival," said N. Anthony Coles, MD, president and chief executive officer, Onyx Pharmaceuticals, Inc. "The approval in liver cancer in China comes less than two years after the approval in advanced kidney cancer and proves that Nexavar is and will continue to be an important foundational therapy in multiple patient populations."
Nexavar is currently approved in more than 40 countries for the treatment of liver cancer and in more than 70 countries for the treatment of advanced kidney cancer. In Europe, Nexavar is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including non-small cell lung cancer (NSCLC), metastatic melanoma, breast cancer and, as an adjuvant therapy, for kidney cancer and liver cancer.
About Hepatocellular Carcinoma
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for about 90 percent of the primary malignant liver tumors in adults. Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally. More than 600,000
cases of liver cancer are diagnosed worldwide each year (more than 400,000 in China, South Korea, Japan and Taiwan, 54,000 in the European Union, and 15,000 in the United States) and the incidence is increasing. In 2002, approximately 600,000 people died of liver cancer including approximately
370,000 in China, South Korea and Japan, 57,000 in the European Union, and 13,000 in the United States.
In addition, chronic hepatitis B (HBV) and C (HCV) viral infections are the leading causes of primary liver cancer worldwide. In the Asia-Pacific region, more than eight percent of the general population are infected with HBV and between two and four percent are infected with HCV.
Nexavar's Differentiated Mechanism
Nexavar® targets both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to target members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®, a small molecule drug. For more information about Onyx, visit the
company's website at: http://www.onyx-pharm.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the worldâs leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCareâs aim is to discover and manufacture products that will
improve human and animal health worldwide. Find more information at http://www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at http://www.bayerscheringpharma.de.