ONXX Onyx Pharmaceuticals, Inc. (MM)

FDA Grants Orphan Drug Designation to BAY 43-9006 for the Treatment of Renal Cell Carcinoma WEST HAVEN, Conn. and RICHMOND, Calif., Oct. 27 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) announced today that sorafenib (BAY 43-9006) has been granted orphan drug status for the treatment of renal cell carcinoma by the U.S. Food and Drug Administration (FDA). The compound is being evaluated for the treatment of metastatic renal cell carcinoma, an advanced form of kidney cancer. A similar designation has been granted in the European Union by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMEA). Currently in Phase III clinical testing, BAY 43-9006 is a novel RAF kinase and VEGFR inhibitor that is intended to prevent tumor growth by combining two anticancer activities: inhibition of tumor cell proliferation and tumor angiogenesis. BAY 43-9006 is being co-developed by Bayer and Onyx. The FDA orphan drug designation provides incentives to companies that develop drugs for diseases affecting less than 200,000 people in the United States. "The orphan drug designation in the U.S. signifies another important step for Bayer and Onyx in the development of BAY 43-9006," said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation. BAY 43-9006 recently received the FDA's fast track designation and both the fast track and orphan drug designation provide mechanisms for more frequent communications with the FDA, helping to streamline development as well as the review and approval process. BAY 43-9006, a novel investigational drug candidate, has demonstrated both anti-proliferative and anti-angiogenic properties -- two important anticancer activities. In preclinical models, BAY 43-9006 inhibited tumor cell proliferation by targeting the RAF/MEK/ERK signaling pathway at the level of RAF kinase. BAY 43-9006 also exerted an antiangiogenic effect by targeting the receptor tyrosine kinases VEGFR-2 and PDGFR and their associated signaling cascades. Renal cell carcinoma is the most common form of kidney cancer. Nearly 190,000 people worldwide (about 32,000 Americans) are diagnosed with renal cell carcinoma each year, and more than 91,000 of them (about 12,000 Americans) die from the disease annually. About Orphan Drug Designation In the U.S., orphan drug designation provides a drug U.S. market exclusivity for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee. The designation does not shorten the duration of the regulatory review and approval process. If a product that has orphan drug designation is the first such product to receive FDA approval for the disease/indication for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications to market the same drug in the U.S. for the same disease, except in limited circumstances, for seven years. The FDA may permit additional companies to market the same drug for the designated condition if such companies can demonstrate better safety, efficacy, or a major contribution to patient care. The FDA may also approve more than one product for the same orphan indication or disease as long as the products are different drugs. About Onyx Pharmaceuticals Onyx Pharmaceuticals is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its partners, the company is developing small molecule drugs, including BAY 43-9006 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, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry. Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Biological Products, Consumer Care, Diagnostics, Animal Health and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare. Our work at Bayer HealthCare is to discover, manufacture and market innovative products for the purpose of improving human and animal health worldwide. Our products enhance well being and quality of life by diagnosing, preventing and treating disease. 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 BAY43-9006. 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 Onyx's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 2004 under the heading "Additional Business Risks" 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. DATASOURCE: Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett of Bayer Pharmaceuticals Corporation, +1-203-812-2160; Helmut Schaefers of Bayer HealthCare Communications, +49-214-30-58308; Julie Wood of Onyx Pharmaceuticals, Inc., +1-510-262-8757 Web site: http://www.bayerpharma.com/ http://www.onyx-pharm.com/

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