Navigation Links
Bayer and Onyx Announce Nexavar Data Presentations at the Joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress

WAYNE, N.J. and EMERYVILLE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that approximately 30 studies evaluating the use of Nexavar((R)) (sorafenib) tablets across tumor types - as a single agent or in combination with other therapies - will be presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress, September 20 - 24 in Berlin.

"The presentations at the ECCO/ESMO conference will continue to build on our large body of data in unresectable liver cancer and advanced kidney cancer where Nexavar has a proven track record," said Dimitris Voliotis, Vice President, Global Clinical Development Oncology. "Additionally, Bayer and Onyx are enthusiastic about presenting Phase 2 studies evaluating the safety and efficacy of Nexavar in other tumor types, including breast and thyroid cancers."

Nexavar data highlights include:

Hepatocellular Carcinoma

  • Effect of Macroscopic Vascular Invasion (MVI), Extrahepatic Spread (EHS), and ECOG Performance Status (ECOG PS) on Outcome in Patients with Advanced Hepatocellular Carcinoma (HCC) Treated with Sorafenib: Analysis of Two Phase 3, Randomized Double-Blind Trials
    • Jean-Luc Raoul, M.D., Centre Eugene Marquis, Rennes, France
    • Abstract 6621, Poster 309, Wednesday, September 23, 2009, 2 p.m. - 5 p.m., Hall 14.1

  • Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC): Collective Results from the Phase III Sorafenib HCC Assessment Randomized Protocol (SHARP) and Asia-Pacific (AP) Trials
    • Josep Llovet, M.D., Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, CIBERehd, IDIBAPS, Hospital Clinic Barcelona, Barcelona, Spain
    • Abstract 6519, Poster 13, Tuesday, September 22, 2009, 8 a.m. - 11 a.m., Poster Discussion, 11:15 a.m. - 12:15 p.m., Central Lobby (Outside Hall 3)

Renal Cell Carcinoma

  • Final Analysis of a Large Open-label, Noncomparative, Phase 3 Study of Sorafenib in European Patients with Advanced RCC (EU-ARCCS)
    • Joachim Beck, M.D., Johannes-Gutenberg-Universitat III. Medizinische Klinik, Mainz, Germany
    • Abstract 7137, Poster 150, Monday, September 21, 2009, 2 p.m. - 5 p.m., Hall 14.1

  • Efficacy and Safety of Long-term Use of Sorafenib: Final Report of a Phase II Trial of Sorafenib in Japanese Patients with Unresectable/Metastatic Renal Cell Carcinoma
    • Hideyuki Akaza, M.D., Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan
    • Abstract 7147, Poster 160, Monday, September 21, 2009, 2 p.m. - 5 p.m., Hall 14.1

  • Efficacy and Safety of Sorafenib in Patients with Advanced Clear-Cell Renal-Cell Carcinoma (RCC) with Bone Metastases: Results from the Phase III TARGET Study
    • Ronald M. Bukowski, M.D., Cleveland Clinic Taussig Cancer Center, Cleveland, OH
    • Abstract 7130, Poster 143, Monday, September 21, 2009, 2 p.m. - 5 p.m., Hall 14.1

  • PREDICT (Patient characteristics in REnal cell carcinoma and Daily practICe Treatment with Nexavar) Global Non-interventional Study: First interim results
    • Dirk Jager, M.D., National Center for Tumor Diseases, University of Heidelberg, Heidelberg, Germany
    • Abstract 7128, Poster 141, Monday, September 21, 2009, 2 p.m. - 5 p.m., Hall 14.1

Breast Cancer

  • A double-blind, randomized phase 2b study evaluating the efficacy and safety of sorafenib (SOR) compared to placebo (PL) when administered in combination with capecitabine (CAP) in patients (pts) with locally advanced (adv) or metastatic (met) breast cancer (BC)
    • Jose Baselga, M.D., Vall d'Hebron University Hospital in Barcelona, Spain
    • Late-breaking abstract 3LBA, Presidential Session III, Wednesday, September 23, 1:30 p.m., Hall 1

Thyroid Cancer

  • Completion of a Phase II study of sorafenib for advanced thyroid cancer
    • Marcia Brose, M.D., Ph.D. Department of Medicine, Division of Hematology/Oncology and Department of Otorhinolaryngology: Head and Neck Surgery, Abrahamson Cancer Center of the University of Pennsylvania, Philadelphia, PA, U.S.A.
    • Late-breaking poster 51LBA, Poster 276, Tuesday, September 22, 11 a.m. - 1:00 p.m. Hall 14.1

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.

Nexavar is currently approved in more than 80 countries for the treatment of patients with liver cancer and in more than 90 countries for the treatment of patients with advanced kidney cancer. Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of cancers, including breast cancer, colorectal cancer, lung cancer, ovarian cancer, and as an adjuvant therapy for kidney cancer and liver 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 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((R)) (sorafenib) tablets, a small molecule drug. For more information about Onyx, visit the company's website at

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 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, 2008, 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.

SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. IVCC launches groundbreaking insecticide projects with Bayer and Syngenta
2. AUDIO from Medialink and Bayer: Simple, Focused Ways to Boost Womens Health
3. Bayer HealthCare Cleared to Acquire Citracal(R)
4. Genzyme and Bayer Schering Pharma AG, Germany to Present New Data on Alemtuzumab in Multiple Sclerosis at ECTRIMS
5. Bayer Foundation Grant Creates Graduate Engineering Fellowship at University of Houston
6. AUDIO from Medialink and Bayer: Is Your Pain Reliever Undermining Your Aspirin Therapy?
7. Bayer Temporarily Suspends Global Trasylol(R) Marketing
8. AUDIO from Medialink and Bayer: Lifesaving Benefits of Low-Dose Aspirin Therapy Maintained with Naproxen Sodium
9. Bayer Plants Trees With Chartiers Valley Intermediate School Students, Provides Free Environmental Education Materials
10. Bayer Awards Making Science Make Sense Grant to Girl Scouts
11. Bayer HealthCare Pharmaceuticals and MedAssets Supply Chain Systems Sign a Three-Year Agreement for Magnevist(R) Magnetic Resonance Contrast Media
Post Your Comments:
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion ... Cut Pro X. With ProSidebar: Fasion, video editors can easily add an informative ... a minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
(Date:11/27/2015)... ... ... A simply groundbreaking television series, "Voices in America", which is hosted by ... of issues that are presently affecting Americans. Dedicated to providing the world with a ... the subjects consumers focus on, one episode at a time. , In the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping in mind challenges ... health and wellness consultation, has collaborated with a leading web-based marketplace for extra-curricular ... experienced by parents and bring advice from parenting experts within their reach. As ...
(Date:11/27/2015)... ... 27, 2015 , ... The men and women on this ... in the country. They have overseen financial turnarounds, shown commitment to their community ... industry as a whole through their advocacy and professional efforts. , Becker's Hospital ...
Breaking Medicine News(10 mins):
(Date:11/29/2015)... , Nov. 29, 2015  The GE Health Cloud ... annual Radiological Society of North America ... for the healthcare industry, the new cloud ecosystem and its ... collaboration across care pathways and multidisciplinary teams – both inside ... , Chairman and CEO of GE. "As the digital industrial ...
(Date:11/27/2015)... Ein neuer Kombinationsansatz vereint ... --> Ein neuer Kombinationsansatz vereint Immuntherapie ... --> Ein neuer Kombinationsansatz vereint Immuntherapie ... Clinical Cancer Research vom 6. November ... vom 6. November 2015 berichtet. --> ...
(Date:11/26/2015)... Un nuevo enfoque combina la ... cáncer avanzado.   --> Un nuevo ... Bremachlorin para el cáncer avanzado.   --> ... la terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... --> Clinical Cancer Research . --> ...
Breaking Medicine Technology: