2008 Press Releases
Bayer and Onyx Announce Nexavar Data Presentations at 44th American Society of Clinical Oncology Annual Meeting
Wayne, NJ and Emeryville, CA May 16, 2008
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced more than 40 data presentations at the 2008 American Society of Clinical Oncology (ASCO) annual meeting demonstrating the potential for Nexavar® (sorafenib) tablets in multiple tumor types as a single agent or in combination with other agents.
"Data at ASCO will expand upon and support the proven efficacy and tolerability of Nexavar in liver cancer and advanced kidney cancer and provide new insight into the potential of Nexavar in additional types of cancer," said Henry Fuchs, MD, executive vice president and chief medical officer of Onyx Pharmaceuticals. "Highlights include studies demonstrating that Nexavar extends life for Asian patients with liver cancer; provides an effective, well-tolerated option for elderly patients with advanced kidney cancer and may provide benefit and warrants further study in heavily pretreated patients with non-small cell lung cancer."
Nexavar data highlights include:
• Randomized Phase III trial of sorafenib versus placebo in Asian patients with advanced hepatocellular carcinoma
o Ann Lii-Cheng, MD, PhD, department of internal medicine, National Taiwan University Hospital, Taipei, Taiwan
o Abstract #4509, oral presentation, Monday, June 02, 2008, 4:30 - 4:45 p.m., E-Hall D2
• Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma and vascular invasion or extrahepatic spread: a subanalysis from the SHARP trial
o Morris Sherman, MD, PhD, associate professor of medicine, University of Toronto, Toronto, Canada
o Poster 37G, abstract #4584, poster, Monday, June 2, 2008, 8 a.m. - 12 p.m., S Hall A1
• Is sorafenib safe and effective in patients with hepatocellular carcinoma (HCC) in Child-Pugh B (CPB) Cirrhosis?
o Ghassan Abou-Alfa, MD, internal medicine, Memorial Sloan Kettering Cancer Center, New York, NY
o Poster 6, abstract #4518, poster discussion, Tuesday, June 3, 2008,
11 - 11:15 a.m., S406
• Efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma according to ECOG performance status: a subanalysis from the SHARP trial
o Jean-Luc Raoul, MD, PhD, Centre Eugene Marquis, Rennes, France
o Poster 38B, Abstract #4587, Monday, June 2, 2008, 8:00 a.m. - 12:00 p.m., S Hall A1
Renal Cell Carcinoma
• Safety and efficacy of sorafenib in elderly patients ≥65 years: a subset analysis from the ARCCs expanded access program in North America
o Ronald Bukowski, MD, director of experimental therapeutics, Cleveland Clinic CICF Taussig Cancer Center, Cleveland, OH
o Poster 17, Abstract 5045, Sunday, June 1, 2008, 8:00 - 12:00 p.m., W375e Lobby. Poster discussion period: 11:00 AM - 12:00 p.m., W375a
• Comparison of kidney cancer symptoms and quality of life (QoL) in renal cell cancer (RCC) patients receiving sorafenib vs. interferon-α (IFN)
o Cezary Szczylik, MD, Central Clinical Hospital, Military Institute of Health, Warsaw, Poland
o Poster 44E, Abstract #9603, Saturday, May 31, 2008, 2:00 - 6:00 p.m., S Hall A1
• Updated results of a Phase I trial of sorafenib and bevacizumab in patients with metastatic renal cell carcinoma (RCC)
o Jeffrey Sosman, MD, professor of medicine (hematology/oncology), Vanderbilt-Ingram Cancer Center, Nashville, TN
o Abstract #5011, Clinical Science Symposium, Saturday, May 31, 2008, 2:15 - 2:30 p.m., W375e
• A randomized discontinuation Phase II study of sorafenib vs placebo in patients with non-small cell lung cancer who have failed at least two prior chemotherapy regimens
o Joan Schiller, MD, professor and chief of the Hematology/Oncology Division at University of Texas Southwestern and Andrea L. Simmons Distinguished Chair in Cancer Research, Dallas, TX
o Abstract #8014, Monday, June 2, 4 - 4:15 p.m., W375e
• A Phase II trial of BAY 43-9006 in patients with platinum treated extensive stage small cell lung cancer (E-SCLC): A SWOG (SO435) Phase II trial
o Barbara Gitlitz, MD, associate professor of clinical, director, Lung, Head and Neck Program, USC/Norris Comprehensive Cancer Center, Los Angeles, CA
o Poster 20, abstract #8039, poster discussion, Monday, June 2, 2008, 12 - 1 p.m., W375d
• A drug interaction study of sorafenib and rapamycin in patients with advanced malignancies
o Tara Gangadhar, MD, fellow, University of Chicago, Chicago, IL
o Poster 10A, abstract #2545, poster discussion, Sunday, June 1, 2008, 2 - 6 p.m., S Hall A1
• A phase II study: Combination of sorafenib with docetaxel and cisplatin in the treatment of metastatic or advanced unresectable gastric and gastroesophageal junction (GEJ) adenocarcinoma (ECOG 5203)
o Weijing Sun, MD, assistant professor of medicine, University of Pennsylvania (Philadelphia, PA) director of Upper GI and Pancreatic-biliary-hepatic Cancer Group and the associate director of the GI Cancer Program
o Poster 23, abstract #4535, poster discussion, Tuesday, June 3, 2008, 11:30 - 11:45 a.m., S406 - Vista Room
• Activity of sorafenib (SOR) in patients (pts) with imatinib (IM) and sunitinib (SU)-resistant (RES) gastrointestinal stromal tumors (GIST): A phase II trial of the University of Chicago Phase II Consortium
o Lauren Wiebe, MD, fellow, University of Chicago, Chicago, IL
o Abstract #10502, oral presentation, Saturday, May 31, 2008, 8:45 - 9 a.m. W375d
• A Phase II study of sorafenib in metastatic thyroid carcinoma
o Marcia S. Brose, MD, PhD, assistant professor, director of cancer genetics laboratory, University of Pennsylvania Health System, Philadelphia, PA
o Poster 18, abstract #6026, poster discussion, Sunday, June 1, 2008, 8 a.m. -12 p.m., E450b
"Along with international study groups and investigators, Bayer and Onyx are committed to a comprehensive clinical trial program evaluating Nexavar for additional types of cancer including lung cancer, breast cancer, melanoma and adjuvant use in kidney cancer," Susan Kelley, MD, vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "With its proven track record in two cancers, dual-targeted mechanism and proven tolerability, we continue to identify important new areas where Nexavar may provide clinical benefit for people affected by 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.
Nexavar is currently approved in more than 40 countries for the treatment of patients with unresectable liver cancer and in more than 70 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 metastatic melanoma, lung cancer, breast cancer and as an adjuvant therapy for 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 ³ 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.
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, 2007, 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.