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Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use Renal Cell Carcinoma Approval Received in Mexico WEST HAVEN, C.T., and EMERYVILLE, C.A. -- April 28, 2006 -- Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. today announced that they have received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for Nexavar(R) (sorafenib) 200 mg film-coated tablets for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer, who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. This positive CHMP opinion will be elevated to the European Commission where a positive ruling could lead to Marketing Authorization for all countries in the European Union in the second half of 2006. The companies also announced the approval of Nexavar (sorafenib) tablets by the Mexican Ministry of Health for the treatment of patients with advanced renal cell carcinoma (RCC), or kidney cancer. Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, will be marketed by Bayer in the EU as well as in Mexico. "This positive opinion from the CHMP -- received earlier than originally anticipated -- marks another important milestone, bringing us one step closer to the global launch of Nexavar," said Dr. Gunnar Riemann, Head of Bayer HealthCare's Pharmaceuticals Division. "With the recent approval by the Mexican Ministry of Health, there are now three countries that have approved Nexavar for the treatment of kidney cancer." Nexavar was approved by the U.S. Food and Drug Administration (FDA) in December 2005 and in March 2006 in Switzerland. In addition, Bayer has completed filings in several countries, including Australia, Brazil, Canada, and Turkey. About Nexavar Nexavar is the first oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation (tumor growth) and tumor angiogenesis (tumor blood supply) -- two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3. Nexavar has been studied in more than 20 tumor types and in nearly 8,000 clinical trial patients. Nexavar is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, and metastatic melanoma, or skin cancer. A Phase III clinical trial in non-small cell lung cancer (NSCLC) was initiated in February 2006. In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators. Important Safety Considerations for U.S. Patients Taking Nexavar Based on the current, approved package insert for the treatment of patients with advanced kidney cancer, hypertension may occur early in the course of therapy and blood pressure should be monitored weekly during the first 6 weeks of therapy and treated as needed. Incidence of bleeding regardless of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential should be advised to avoid becoming pregnant and advised against breast-feeding. In cases of any severe or persistent side effects, temporary treatment interruption, dose modification or permanent discontinuation should be considered. Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer Pharmaceuticals Corporation. SOURCE: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version