Nexavar Data to be Presented at 46th American Society of Clinical Oncology Annual Meeting

WAYNE, N.J. and EMERYVILLE, Calif., May 20 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that more than 70 studies evaluating the use of Nexavar® (sorafenib) tablets will be presented at the 2010 American Society of Clinical Oncology (ASCO) annual meeting in Chicago.

"Bayer and Onyx are encouraged by the number and breadth of studies involving Nexavar that are being presented at ASCO," said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. "We have built a strong foundation with Nexavar in the treatment of patients with unresectable liver cancer and advanced kidney cancer and are committed to continuing research across tumor types and in a variety of treatment settings to determine the full potential of this therapy for cancer patients."

Nexavar highlights include:

Hepatocellular Carcinoma (HCC)

• Sorafenib or Placebo in Combination with Transarterial Chemoembolization (TACE) for Intermediate-Stage Hepatocellular Carcinoma (SPACE)
  • Professor Riccardo Lencioni, Division of Diagnostic and Interventional Radiology, Cisanello University Hospital, Pisa, Italy
  • Abstract TPS178, Trials in Progress Poster Session, Clinical Trials Special Session
  • Monday, June 7, 2010, 8:00 a.m.-12:00 p.m., S Hall A2
• Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma; Subgroup Analysis of the SHARP Trial by Baseline Transaminase (ALT/AST)/alpha-Fetoprotein (AFP) and Bilirubin Levels  
  • Jean-Luc Raoul, M.D., Ph.D., Centre Eugene Marquis, Rennes, France
  • Abstract 4051, General Poster Session, Gastrointestinal (Noncolorectal) Cancer Track
  • Sunday, June 6, 2010, 2:00-6:00 p.m., S Hall A2

Renal Cell Carcinoma (RCC)

• Long-term Sorafenib Safety Profile in More Than 700 Patients with Renal-Cell Carcinoma Treated for 12 to 42 Months
  • Thomas E. Hutson, DO, PharmD, FACP, Texas Oncology, PA, Baylor Sammons Cancer Center, Baylor University Medical Center Dallas, Texas
  • Abstract 4614, General Poster Session, Genitourinary Cancer Track
  • Monday, June 7, 2010, 1:00-5:00 p.m., S Hall A2

Lung Cancer

• Sorafenib Treatment Efficacy and KRAS Biomarker Status in the Biomarker-Integrated Approaches of Targeted Therapy for Lung Cancer Elimination (BATTLE) trial.
  • Roy Herbst, M.D., Ph.D., Department of Thoracic/Head and Neck Medical Oncology, MD Anderson Cancer Center, Houston, Texas
  • Abstract 7609, General Poster Session, Lung Cancer – Metastatic Track
  • Sunday, June 6, 2010, 8:00 a.m.-12:00 p.m., S Hall A2

Breast Cancer

• Multivariate Analysis (MVA) of Progression-Free Survival (PFS) in 2 Phase 2b, Multinational, Double-Blind, Randomized, Placebo-Controlled Trials Evaluating Sorafenib Plus Standard Chemotherapy in Patients with HER-2 Negative Locally advanced or Metastatic Breast Cancer.
  • William John Gradishar, M.D., Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • Abstract 1073, General Poster Session, Breast Cancer Track
  • Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2
• A Regional Subgroup Analysis of a Multinational, Double-Blind, Randomized, Placebo Controlled, Phase 2b Study Evaluating Sorafenib (SOR) with Paclitaxel (PAC) in Patients (pts) with Advanced Breast Cancer (BC).
  • Tarini Prasad Sahoo, M.D., Jawaharlal Nehru Cancer Hospital & Research Centre, Bhopal, India
  • Abstract 1114, General Poster Session, Breast Cancer Track
  • Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2
• Management of Hand-Foot Skin Reaction (HFSR)/Hand-Foot Syndrome (HFS) in SOLTI-0701: A Double-Blind, Randomized Phase 2b Study Comparing Sorafenib vs Placebo in Combination with Capecitabine in Patients with Advanced Breast Cancer.
  • Patricia Gomez, M.D., Breast Cancer Center, Vall d'Hebron University Hospital, Barcelona, Spain
  • Abstract 1083, General Poster Session, Breast Cancer Track
  • Saturday, June 5, 2010, 2:00-6:00 p.m., S Hall A2

"With more than 70 investigator and company sponsored studies being presented at ASCO, we look forward to continuing our work with investigators to understand how Nexavar may fit into other areas of the therapeutic landscape, particularly with respect to how biomarkers status may guide selection of therapy, which is a step toward personalized medicine," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development at Onyx Pharmaceuticals.  

Nexavar's Differentiated Mechanism

Nexavar, an oral anti-cancer therapy, is currently approved in more than 90 countries for liver cancer where it remains the only approved systemic agent proven to extend survival and in more than 95 countries for the treatment of patients with advanced kidney cancer.  Nexavar inhibits processes involved in both the tumor cell and tumor vasculature.  In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought 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, PDGFRB, KIT, FLT-3 and RET.  

Nexavar is also being evaluated by other companies, international study groups, government agencies and individual investigators as a single agent or as a combination treatment in a wide range of cancers, including lung, thyroid, breast, ovarian, and colorectal cancer and as an adjuvant therapy for liver and kidney cancer. 

Important Safety Considerations For Patients Taking Nexavar

Based on the currently approved U.S. package insert for the treatment of patients with unresectable hepatocellular carcinoma and 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.  In HCC patients, bleeding with a fatal outcome from any site was reported in 2.4% for Nexavar and 4% in placebo.  The incidence of treatment-emergent cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for placebo.  In RCC patients, 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 adverse events >/=20% related to Nexavar for both HCC and RCC were fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, nausea, and abdominal pain.  Grade 3/4 adverse events in HCC and RCC patients, respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 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 information about Nexavar including U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).

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.

About Onyx Pharmaceuticals, Inc.

Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of people with cancer. The company, in collaboration with Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar® (sorafenib) tablets, a small molecule drug that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next-generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors.  ONX 0801, a targeted alpha-folate inhibitor, is currently in Phase 1 testing. For more information about Onyx, visit the company's website at www.onyx-pharm.com.

Forward-Looking Statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 which are available on the Bayer Web site at www.bayer.com.  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 timing, progress and results of the clinical development, safety, regulatory processes, commercialization efforts or commercial potential 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, 2009, 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® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.

SOURCE Bayer HealthCare Pharmaceuticals, Inc.; Onyx Pharmaceuticals, Inc.

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