Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer

Nexavar is First Drug Therapy to Demonstrate Significant Survival Benefit

in Liver Cancer

    WAYNE, N.J. and EMERYVILLE, Calif., June 27 /PRNewswire-FirstCall/ --
 Bayer HealthCare Pharmaceuticals Inc. ( BAY) and Onyx Pharmaceuticals,
 Inc. ( ONXX) today announced that a Supplemental New Drug
 Application (sNDA) for Nexavar(R) (sorafenib) tablets has been submitted to
 the U.S. Food and Drug Administration (FDA) for the treatment of patients
 with hepatocellular carcinoma (HCC), the most common form of liver cancer.
 Nexavar is currently approved in more than 50 countries for the treatment
 of advanced kidney cancer. The companies also confirmed that they are
 planning a company- sponsored Phase 3 study of Nexavar in the adjuvant
 treatment of HCC following the complete removal of early stage liver
 cancer.
     The sNDA submission is based on positive data from the international,
 Phase 3, placebo-controlled 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 significant differences in serious adverse event rates between the
 Nexavar and placebo-treated groups with the most commonly observed adverse
 events in patients receiving Nexavar being diarrhea and hand-foot skin
 reaction. Currently, there are no FDA-approved drug therapies that
 significantly extend survival of patients with liver cancer.
     "These results are particularly meaningful considering that death rates
 from liver cancer continue to increase," said Susan Kelley, M.D., vice
 president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals.
 "After more than 100 clinical studies of many agents over three decades,
 Nexavar is the first drug therapy to demonstrate a significant survival
 benefit for patients with HCC, and, if approved, may fulfill a serious
 unmet need with a manageable toxicity profile."
     HCC, the most common form of liver cancer, is responsible for about 90
 percent of the primary liver cancers in adults.(1,2) It is the fifth most
 common cancer in the world(3) and the third leading cause of cancer-related
 deaths globally.(4) Over 600,000 cases of HCC are diagnosed globally each
 year(4) (about 19,000 in the United States(5) and 32,000 in the European
 Union(6)) and in 2002 approximately 600,000 people (about 13,000 Americans
 and 57,000 Europeans) died of HCC.(7)
     "This filing exemplifies our commitment to providing valuable
 therapeutic options for significant unmet needs in cancer treatment," said
 Hank Fuchs, M.D., executive vice president and chief medical officer of
 Onyx. "We believe that Nexavar will become the reference standard of care
 in HCC, and will help advance our development program, which includes
 clinical trials studying Nexavar alone and in combination with other
 therapies across many different cancer types, including melanoma, non-small
 cell lung and breast cancer."
     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. Nexavar is approved for the treatment of
 advanced kidney cancer in more than 50 countries. For more information
 about Onyx's pipeline and activities, visit the company's web site at:
 www.onyx-pharm.com.
     About Bayer HealthCare
     Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
 unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's
 leading, innovative companies in the healthcare and medical products
 industry, Bayer HealthCare combines the global activities of the Animal
 Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the
 US, Bayer HealthCare Pharmaceuticals comprises the following business
 units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics,
 Hematology/Cardiology and Oncology. 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. World Health Organization. Estimates by WHO Region: Incidence.
        Available at:
        http://www.who.int/healthinfo/statistics/gbdwhoregionincidence2002.xls.
        Accessed April 10, 2007.
     4. International Agency for Cancer Research. GLOBOCAN 2002. Available at:
        http://www dep.iarc.fr. Accessed April 23, 2007.
     5. Jemal A et al. CA Cancer J Clin. 2007;57:43-66.
     6. International Agency for Cancer Research. EUCAN 1998. Available at:
        http://www-dep.iarc.fr/eucan/eucan.htm. Accessed April 26, 2007.
     7. 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 Inc.; Onyx Pharmaceuticals, Inc.