Bayer and Onyx Announce Nexavar® (sorafenib tosylate) Tablets as Global Trade Name for Investigational Cancer Treatment
WEST HAVEN, Conn. & EMERYVILLE, Calif. — Oct. 28, 2005
Contact:
Julie Wood
510-597-6505
Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the selection of Nexavar® (sorafenib tosylate) Tablets as the global trade name for sorafenib, the oral investigational drug under FDA review for the treatment of advanced renal cell carcinoma (RCC), or kidney cancer.
Bayer and Onyx filed a New Drug Application (NDA) in July 2005 requesting approval in advanced renal cell cancer by the U.S. Food and Drug Administration (FDA). Subsequently, the FDA granted the Nexavar filing priority review status, which means the FDA intends to make a determination within six months of when they received the NDA. Additionally in September 2005, a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency (EMEA) to market Nexavar in Europe. If approved, Nexavar will be marketed by Bayer and Onyx through a co-promotion and co-development agreement.
About Nexavar
Nexavar® (sorafenib tosylate) Tablets, a novel investigational agent, is the first oral multi-kinase inhibitor that targets kinases in both the tumor cell and its vasculature. In preclinical models, Nexavar blocked kinases known to be involved in proliferation (tumor growth) and angiogenesis (tumor blood supply) - two important cancer growth activities. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, 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 Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx's pipeline and activities, visit the company's web site at: www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (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, the timing and outcome of regulatory processes, and the commercialization efforts of Nexavar. 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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