Nexavar

Treatment for Renal Cell Carcinoma

Bayer and Onyx Announce FDA Acceptance of New Drug Application for Sorafenib for Individuals with Advanced Renal Cell Carcinoma


Priority Review Designation Granted

WEST HAVEN, Conn. and EMERYVILLE, Calif., September 14, 2005 -- Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for sorafenib (BAY 43-9006) for patients with advanced renal cell carcinoma (RCC), or kidney cancer, has been accepted for review and granted Priority Review status by the U.S. Food and Drug Administration (FDA).

Priority Review designation expedites the approval process for investigational agents that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within six months of the date on which they received the NDA.

"This, along with our recent European filing, puts us ahead of schedule in our global regulatory strategy," said Wolfgang Plischke, President of Bayer HealthCare's Global Pharmaceutical Division.

The US submission, which was completed in July 2005, was based on an ongoing Phase III trial in patients with advanced kidney cancer. Results from the study -- the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer -- were presented in May at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO).

Sorafenib is currently available in the United States to patients with advanced kidney cancer through a treatment protocol known as the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) study. To be eligible, individuals may not have been previously treated with sorafenib and should call 1-866-639- 2827. A similar trial will start in Europe shortly, and Bayer and Onyx are in discussions with regulators about similar programs in other territories.

About Sorafenib

Sorafenib, a novel investigational drug candidate, is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature. In preclinical models, sorafenib 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-beta, KIT, FLT-3 and RET.

Source: Onyx Pharmaceuticals, Inc. and Bayer Pharmaceuticals Corporation

Posted: September 2005

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