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., — Sep. 14, 2005
Contact:
Julie Wood
510-597-6505
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.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including sorafenib with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at: http://www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subgroup of Bayer AG.
Bayer HealthCare, with sales of approximately 8.5 billion Euro in 2004, is one of the world's leading, innovative companies in the health care and medical products industry. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Our aim is to discover and manufacture innovative products that will improve human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the timing, progress and results of the clinical development, regulatory processes and commercialization efforts of sorafenib. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2004, as amended, filed with the Securities and Exchange Commission under the heading "Additional Business Risks" and Onyx's Quarterly Reports on Form 10-Q for a more detailed description of such factors. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date of this release. Onyx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date of this release except as required by law.
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