Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use for Treatment of Liver Cancer

    WAYNE, N.J. and EMERYVILLE, Calif., Sept. 21 /PRNewswire-FirstCall/ --
 Bayer HealthCare Pharmaceuticals (NYSE:   BAY) and Onyx Pharmaceuticals, Inc.
 (Nasdaq:   ONXX) today announced that the European Committee for Medicinal
 Products for Human Use (CHMP) has issued a positive opinion, recommending
 to grant marketing authorization for Nexavar(R) (sorafenib) tablets for the
 treatment of patients with hepatocellular carcinoma (HCC), or liver cancer.
 This positive CHMP opinion will be elevated to the European Commission
 where a likely favorable ruling could lead to Marketing Authorization for
 European Union Member States this year. Nexavar is currently approved in
 more than 50 countries for the treatment of patients with advanced kidney
 cancer.
     "The positive opinion issued by the CHMP marks another significant
 milestone for Nexavar in liver cancer," said Gunnar Riemann, Ph.D., member
 of the Bayer HealthCare Executive Committee. "The Committee's decision
 underscores the potential of Nexavar to become the standard systemic drug
 therapy for the treatment of liver cancer."
     The CHMP positive opinion was based on data from the Phase 3 Sorafenib
 HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that
 Nexavar extended overall survival by 44 percent in patients with HCC
 (HR=0.69; p=0.0006) versus placebo. There were no meaningful differences in
 serious adverse event rates between the Nexavar and placebo-treated groups
 with the most commonly observed serious adverse events in patients
 receiving Nexavar being diarrhea and hand-foot skin reaction. Based on
 these data, a supplemental New Drug Application for Nexavar was also
 granted Priority Review status by the U.S. Food and Drug Administration
 (FDA) in August.
     "This decision, coupled with the Priority Review status granted by the
 FDA, means that patients in these regions are one step closer to a new
 treatment for their liver cancer," said Hollings Renton, chairman,
 president and chief executive officer of Onyx Pharmaceuticals, Inc.
     HCC, the most common form of liver cancer, is responsible for about 90
 percent of the primary malignant liver tumors in adults.(1,2) Liver cancer
 is the sixth most common cancer in the world and the third leading cause of
 cancer-related deaths globally.(3) Over 600,000 cases of liver cancer are
 diagnosed globally each year(3) (about 19,000 in the United States(4) and
 32,000 in the European Union(5)) and in 2002 approximately 600,000 people
 died of liver cancer including 13,000 in the United States, 57,000 in
 Europe and approximately 360,000 in China, Korea and Japan.(6)
     Nexavar's Differentiated Mechanism
     Nexavar targets both the tumor cell and tumor vasculature. In
 preclinical studies, Nexavar has been shown to target members of two
 classes of kinases known to be involved in both cell proliferation (growth)
 and angiogenesis (blood supply) -- two important processes that enable
 cancer growth. These kinases included Raf kinase, VEGFR-1, VEGFR-2,
 VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Preclinical models have also
 demonstrated that Raf/MEK/ERK has a role in HCC; therefore blocking
 signaling through Raf-1 may offer therapeutic benefits in HCC.
     Important Safety Considerations for U.S. Patients Taking Nexavar
     Based on the currently approved package insert for the treatment of
 patients with advanced kidney cancer, hypertension may occur early in the
 course of therapy and blood pressure should be monitored weekly during the
 first six weeks of therapy and treated as needed. Incidence of bleeding
 regardless of causality was 15% for Nexavar vs. 8% for placebo and the
 incidence of treatment-emergent cardiac ischemia/infarction was 2.9% for
 Nexavar vs. 0.4% for placebo. Most common treatment-emergent adverse events
 with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin
 reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for
 Nexavar vs. 28% for placebo. Women of child-bearing potential should be
 advised to avoid becoming pregnant and advised against breast-feeding. In
 cases of any severe or persistent side effects, temporary treatment
 interruption, dose modification or permanent discontinuation should be
 considered.
     For U.S. Nexavar prescribing information, visit www.nexavar.com or call
 1.866.NEXAVAR (1.866.639.2827).
     About Onyx Pharmaceuticals, Inc.
     Onyx Pharmaceuticals, Inc. is a biopharmaceutical company developing
 innovative therapies that target the molecular mechanisms that cause
 cancer. The company is developing Nexavar(R), a small molecule drug, 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 HealthCare Pharmaceuticals
     Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
 unit of Bayer HealthCare LLC, a division of Bayer AG. Its research and
 business activities are focused on the following areas: Diagnostic Imaging,
 Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and
 Women's Healthcare. The company's aim is to discover and manufacture
 products that will improve human health worldwide by diagnosing, preventing
 and treating diseases.
     About Bayer Schering Pharma AG, Germany
     Bayer Schering Pharma is a worldwide leading specialty pharmaceutical
 company. Its research and business activities are focused on the following
 areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care,
 Specialized Therapeutics and Women's Healthcare. With innovative products,
 Bayer Schering Pharma aims for leading positions in specialized markets
 worldwide. Using new ideas, Bayer Schering Pharma aims to make a
 contribution to medical progress and strives to improve quality of life.
     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 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, 2006, filed with
 the Securities and Exchange Commission under the heading "Risk Factors" 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.
     Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer
 Pharmaceuticals Corporation.
     References
     (1). World Health Organization. Hepatitis B. Available at:
          http://www.who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/.
          Accessed April 10, 2007
     (2). Penn State Milton S. Hershey Medical Center College of Medicine.
          Malignant Hepatoma. Available at:
          http://www.hmc.psu.edu/healthinfo/m/malignanthepatoma.htm. Accessed
          April 10, 2007.
     (3). International Agency for Cancer Research. GLOBOCAN 2002. Available
          at: http://www-dep.iarc.fr. Accessed April 23, 2007.
     (4). Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
     (5). International Agency for Cancer Research. EUCAN 1998. Available at:
          http://www-dep.iarc.fr/eucan/eucan.htm. Accessed April 26, 2007.
     (6). Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and
          Prevalence Worldwide. IARC CancerBase No.5, Version 2.0. IARCPress,
          Lyon, 2004. Available at: http://www-dep.iarc.fr. Accessed April 10,
          2007.
 
 

SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.