ONXX Onyx Pharmaceuticals, Inc. (MM)

Bayer and Onyx Announce Results of Phase I Studies Evaluating BAY 43-9006 in Combination with Conventional Chemotherapy Drugs WEST HAVEN, Conn. and RICHMOND, Calif., Nov. 2 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) announced results from several Phase I clinical trials of BAY 43-9006 administered in combination with conventional chemotherapy drugs in patients with various tumor types including, hepatic cancer and colorectal cancer. The data were presented at the 29th European Society of Medical Oncology (ESMO) meeting in Vienna, Austria. Data from these Phase I safety and pharmacokinetic (metabolism) interaction studies showed that BAY 43-9006 could be combined with the other anticancer agents evaluated (doxorubicin, oxaliplatin, fluorouracil and leucovorin). In addition, data show that BAY 43-9006 required no dose adjustment when administered with ketoconazole (CYP3A inhibitor). Safety data generated across all studies showed no unexpected treatment-related adverse events. BAY 43-9006, a novel RAF kinase and VEGFR inhibitor under investigation for the treatment of different types of cancer, combines two anticancer activities: inhibition of tumor cell proliferation and angiogenesis (the growth of new blood vessels). BAY 43-9006 ESMO Data BAY 43-9006 data being presented at this year's ESMO meeting include: -- Results of a Phase I trial of BAY 43-9006 in combination with doxorubicin in patients with primary hepatic cancer. H. Richly, MD. -- Results of a Phase I combination trial of BAY 43-9006 with oxaliplatin in patients with colorectal cancer. P. Kupsch, MD. -- Phase I trial of BAY 43-9006 in combination with 5-fluorouracil (5-FU) and leucovorin (LCV) in patients with advanced refractory solid tumors. A. Figer, MD. -- A randomized Phase I clinical and biologic study of two schedules of the C-RAF kinase inhibitor BAY 43-9006 in patients with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML): A NCI Canada Clinical Trials Group study. M. Crump, MD. -- Lack of effect of ketoconazole, a CYP3A inhibitor, on BAY 43-9006 clinical pharmacokinetics. C.D. Lathia, Ph. D. About BAY 43-9006 BAY 43-9006, a novel investigational drug candidate, has demonstrated 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. BAY 43-9006 is currently undergoing Phase III evaluation for the treatment of advanced kidney cancer and Bayer and Onyx intend to initiate additional Phase II and Phase III trials in other tumor types. For more information on BAY 43-9006 clinical trials, visit http://www.clinicaltrials.gov/ . 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 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 AG, a subgroup of Bayer AG. Bayer HealthCare, with sales of approximately 8.9 billion Euro in 2003, 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. About 34,600 people are employed by Bayer HealthCare worldwide. 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 BAY 43-9006. 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" and Onyx's subsequent 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. 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; Geoff Curtis of GCI Group, +1-312-229-8702 Web site: http://www.bayerpharma.com/ http://www.onyx-pharm.com/

Copyright