Nexavar First FDA-Approved Drug Therapy for Liver Cancer

    WAYNE, N.J. and EMERYVILLE, Calif., Nov. 19 /PRNewswire-FirstCall/ --
 Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq:  
 ONXX) today announced that the U.S. Food and Drug Administration (FDA) has
 approved a supplemental New Drug Application for Nexavar(R) (sorafenib)
 tablets for the treatment of patients with unresectable hepatocellular
 carcinoma (HCC), or liver cancer. Nexavar, an oral anticancer drug, is the
 first approved systemic therapy for liver cancer and the only one shown to
 significantly improve overall survival in patients with the disease. In
 2005 Nexavar became the first new treatment in more than a decade for
 advanced kidney cancer, and is currently approved in more than 60 countries
 for this indication.
     "The approval of Nexavar in liver cancer marks the second time in two
 years that this novel kinase inhibitor has been granted FDA approval on a
 Priority Review basis, making it rapidly available to patients who
 previously had limited treatment options," said Arthur Higgins, chairman of
 the Executive Committee of Bayer HealthCare. "This milestone will likely
 establish Nexavar as the standard systemic therapy for the treatment of
 liver cancer, and is a turning point in improving treatment outcomes in
 patients facing the devastating impact of this disease."
     "Liver cancer is one of the cancers in which the number of related
 deaths continues to increase," said Hollings C. Renton, chairman, president
 and chief executive officer of Onyx Pharmaceuticals, Inc. "This second
 approval for Nexavar demonstrates our commitment to expediting the clinical
 development of this innovative therapy to treat today's unmet needs in
 cancer. We are grateful to the patients, families and investigators who
 make this important research possible."
     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) More than 600,000 cases of liver cancer
 are diagnosed worldwide each year(3) (about 19,000 in the United States,(4)
 54,000(5) in Europe,(6) and 390,000 in China, Korea and Japan(6)) and
 incidence is increasing.(7) In 2002 approximately 600,000 people died of
 liver cancer including 13,000 in the United States, 57,000(5) in Europe and
 approximately 360,000 in China, Korea and Japan.(6) Currently, the 5-year
 survival rate for liver cancer patients in the United States is 11
 percent.(8)
     "The American Liver Foundation (ALF) is always pleased when new
 therapies prove effective for those affected by liver disease. Researchers
 worldwide, including those supported by ALF, have spent decades studying
 liver cancer," said James L. Boyer, M.D., chairman, board of directors,
 American Liver Foundation. "This new treatment provides a valuable option
 for liver cancer patients and will enable ALF to further promote the
 treatment of liver disease through our education and advocacy efforts."
     The companies also announced that an innovative patient support program
 - Resources for Expert Assistance and Care Helpline (REACH(R)) - is
 available to answer questions about Nexavar treatment, reimbursement, and
 patient support. For more information, healthcare providers and patients
 may contact the REACH program at 1.866.NEXAVAR (1.866.639.2827).
     Phase 3 Data Summary
     The FDA approval was based on positive data from the international
 Phase 3 placebo-controlled Sorafenib HCC Assessment Randomized Protocol
 (SHARP) trial which demonstrated that Nexavar improved overall survival by
 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo. In the
 study, median overall survival was 10.7 months in Nexavar-treated patients
 compared to 7.9 months in those taking placebo. No indication of imbalances
 was observed in serious adverse events 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.
 Based on these data, the European Commission granted marketing
 authorization to Nexavar for the treatment of patients with hepatocellular
 carcinoma on October 29, 2007.
     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 unresectable hepatocellular carcinoma, 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.
 Bleeding with a fatal outcome from any site was reported in 2.4% for
 Nexavar vs. 4% in placebo. The incidence of treatment-emergent cardiac
 ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo. Most common
 adverse events reported with Nexavar in patients with unresectable HCC were
 diarrhea, fatigue, weight loss, anorexia, nausea and hand-foot skin
 reaction. Grade 3/4 adverse events were 45% for Nexavar vs. 32% 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 information about Nexavar including 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 HealthCare Pharmaceuticals Inc. Nexavar is approved for the treatment
 of advanced kidney cancer in more than 60 countries. For more information
 about Onyx's pipeline and activities, visit the company's web site at:
 www.onyx-pharm.com.
     About Bayer HealthCare Pharmaceuticals Inc.
     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
 U.S., 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.
     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 our
 annual and interim reports filed with the Frankfurt Stock Exchange. The
 company 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
 HealthCare Pharmaceuticals Inc.
     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) The reported mortality of HCC in Europe is higher than the incidence
         of HCC in Europe.  This is due to the overestimation of mortality by
         occasional counting of metastatic cancers that have spread to the
         liver, and underestimation of incidence as a result of a lack of
         technology for early detection and diagnosis of HCC.  Source:
         International Agency for Research on Cancer.
     (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.
     (7) Ries LAG, Melbert D, Krapcho M, Mariotto A, Miller BA, Feuer EJ, Clegg
         L, Horner MJ, Howlader N, Eisner MP, Reichman M, Edwards BK (eds).
         SEER Cancer Statistics Review, 1975-2004, National Cancer Institute.
         Bethesda, MD, http://seer.cancer.gov/csr/1975_2004/, based on November
         2006 SEER data submission, posted to the SEER web site, 2007.
     (8) American Cancer Society. Cancer Facts & Figures 2007. Atlanta:
         American Cancer Society: 2007.
 
 

SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.