2009 Press Releases
Bayer and Onyx Announce Nexavar Data Presentations at 45th American Society of Clinical Oncology Annual Meeting
Wayne, NJ and Emeryville, CA — May 14, 2009
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that more than 65 studies evaluating the use of Nexavar® (sorafenib) tablets will be presented at the 2009 American Society of Clinical Oncology (ASCO) annual meeting.
"Nexavar has a proven track record in two cancers - in the treatment of unresectable hepatocellular carcinoma (HCC), or liver cancer, and in the treatment of advanced renal cell carcinoma (RCC), or kidney cancer," said Laura Brege, executive vice president and chief operating officer at Onyx Pharmaceuticals. "We continue to explore the potential of Nexavar in other tumor types with several studies being presented at ASCO."
Nexavar data highlights include:
- Effect of Macroscopic Vascular Invasion, Extrahepatic Spread, and ECOG Performance Status on Outcome in Patients with Advanced Hepatocellular Carcinoma Treated with Sorafenib: Analysis of Two Phase 3, Randomized Double-Blind Trials
Jordi Bruix, M.D., Director, BCLC Group, Liver Unit, Hospital Clinic, University of Barcelona, Spain
Abstract 4580, Poster, Sunday, May 31, 2009, 8:00 a.m.- 12:00 p.m., Level 2, West Hall C
- Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma : Asia-Pacific Trial Subgroup Analyses by Baseline Transamanase / α-Fetoprotein Levels
Shukui Qin, M.D., Department of Gastroenterology, First Affiliated Hospital of Guangxi Medical University, Guangxi, Nanning, China
Abstract 4590, Poster, Sunday, May 31, 2009, 8:00 a.m.-12:00 p.m., Level 2, West Hall C
Renal Cell Carcinoma
- A Multitargeted, Metronomic, and Maximum-Tolerated Dose "Chemo-Switch" Regimen Produces Enhanced Activity in Metastatic Renal Cell Carcinoma: A Phase 2 Study of Sorafenib, Gemcitabine and Metronomic Capecitabine in Patients with Advanced mRCC
Joaquim Bellmunt, M.D., Chief of the Solid Tumor Oncology Section, Medical Oncology Service, University Hospital del Mar-IMIM, Barcelona, Spain
Abstract 5040, Poster Discussion, Friday, May 29, 2009, 2:00 p.m.-6:00 p.m., Level 2, W230A
- A Randomized, Open Label, Prospective Study Comparing the Association Between Sorafenib and Interleukin-2 Versus Sorafenib Alone in Advanced Untreated Renal Cell Carcinoma
Giuseppe Procopio, M.D., Istituto Tumori Milano, Milan, Italy
Abstract 5099, Poster, Sunday, May 31, 2009, 2:00 p.m.-6:00 p.m., Level 2, West Hall C
- A Phase 2 Study of Recombinant IL-21 Plus Sorafenib as Second- or Third-Line Therapy for Metastatic Renal Cell Cancer
Shailender Bhatia, M.D., Fred Hutchinson Cancer Research Center, University of Washington, Seattle, WA, U.S.A.
Abstract 3023, Poster Discussion, Sunday, May 31, 2009, 2:00 p.m.- 6:00 p.m., Level 3, W315A
- Effect of BRAFV600E on Response to Sorafenib in Advanced Thyroid Cancer Patients
Marcia Brose, M.D., Assistant Professor of Hematology-Oncology and Otorhinolaryngology: Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, PA, U.S.A.
Abstract 6002, Clinical Science Symposium, Monday, June 1, 2009, 9:45 a.m. - 11:15 a.m., Level 2, West Hall F3
- A Phase 2 Study of Sorafenib and Erlotinib in Chemotherapy-Naïve Patients with Locally Advanced/Metastatic Non-Small Cell Lung Cancer
Joline S. Lind, M.D., Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, The Netherlands
Abstract 8018, Poster Discussion, Monday, June 1, 2009, 8:00 a.m.-12:00 p.m., Level 3, W340A
Acute Myeloid Leukemia
- Phase 1/2 Study of Idarubicin, High Dose Ara-C and Sorafenib in Patients with Acute Myeloid Leukemia Younger than 65 Years
Farhad Ravandi, M.D., The University of Texas M.D. Anderson Cancer Center, Houston, TX, U.S.A.
Abstract 7018, Poster Discussion, Friday, May 29, 2009, 2:00 p.m.-6:00 p.m., Level 2, W240A
- A Phase I Dose-Finding Study of Sorafenib in Combination with Capecitabine and Cisplatin as a First-Line Treatment in Patients with Advanced Gastric Cancer
Chul Kim, M.D., Yoon-Koo Kang, M.D., Asan Medical Center, Seoul, Republic of Korea
Abstract 4559, Poster, Sunday, May 31, 2009, 8:00 a.m.-12:00 p.m., Level 2, West Hall C
"We are committed to exploring the full potential of Nexavar," said Mark Gelder, M.D., V.P., Global Medical Affairs, Oncology at Bayer HealthCare. "The more data we compile that help us understand the potential utility of Nexavar, the closer we are to achieving our ultimate goal of helping to improve the lives of patients."
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 70 countries for the treatment of patients with liver cancer and in more than 80 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 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. For more information about Onyx, visit the company's website at www.onyx-pharm.com.
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, safety, 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, 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® (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.