2008 Press Releases
New Analyses Confirm Nexavar's Efficacy and Safety In Multiple Patient Subsets with Liver Cancer
Wayne, NJ and Emeryville, CA Oct. 31, 2008
Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that new Nexavar data will be presented at the upcoming 59th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) demonstrating the clinical application of Nexavar® (sorafenib) tablets in multiple patient subsets with hepatocellular carcinoma (HCC), or liver cancer. Nexavar is the only systemic treatment to demonstrate prolonged overall survival in unresectable HCC and is currently approved in more than 60 countries for the treatment of the disease.
Data will be presented evaluating specific patient subpopulations from the Phase 3 SHARP (Sorafenib HCC Assessment Randomized Protocol) and Asia Pacific trials. The trials enrolled 602 and 226 patients, respectively, with advanced, unresectable HCC who had not received prior systemic therapy. Patients in both studies were randomized to receive either Nexavar 400 mg twice daily or placebo. Data from both Phase 3 trials demonstrated that patients treated with Nexavar experienced a significant improvement in overall survival; 44% (HR=0.69; p-value=0.0006) in the SHARP trial and 47% (HR=0.68; p-value=0.014) in the Asia Pacific trial.
"The SHARP and Asia Pacific trials continue to increase our understanding and provide clinical confirmation of the efficacy, safety and clinical benefit of Nexavar in patients with liver cancer," said Mark Gelder, MD, vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "As leaders in the liver cancer field, Bayer and Onyx are committed to evaluating these data comprehensively in order to maximize the potential benefit Nexavar may offer to these patients."
Nexavar data will include:
Sorafenib is Effective in Patients from the Asia-Pacific Region with Hepatocellular Carcinoma (HCC): Subgroup Analysis of Effect of Macroscopic Vascular Invasion, Extrahepatic Spread, and ECOG Performance Status on Outcome
Yoon-Koo Kang - ASAN Medical Center, Songpa-gu, Seoul, South Korea.
Monday, November 3, 2008, 8 a.m. - 5:30 p.m. PDT, West Hall
Data presented in this subanalysis demonstrated that Nexavar is effective for the treatment of HCC in patients from the Asia-Pacific region (n=150) with a safety profile consistent with the overall study population, independent of baseline ECOG performance status and the presence or absence of macroscopic vascular invasion (MVI) and/or extrahepatic spread (EHS).
Sorafenib for the Treatment of Alcohol-Related Hepatocellular Carcinoma (HCC): Subanalysis of the Phase III SHARP Trial
Dr. Antonio Craxi Azienda Ospedaliera Universitaria "Paolo Giaccone", Palermo, Italy.
Monday, November 3, 2008, 8 a.m. - 5:30 p.m. PDT, West Hall
Alcohol-related cirrhosis is a major etiologic factor for HCC. Investigators performed a subgroup analysis of patients with alcohol-related HCC who were enrolled in the SHARP trial. Data from this subanalysis demonstrated that Nexavar treatment is effective in patients with alcohol-related HCC (n=159) with a comparable safety profile to the overall SHARP study population.
"With a growing body of Nexavar data and proven efficacy in HCC, investigators are interested in further exploring additional uses for Nexavar in these patients," Henry Fuchs, MD, executive vice president and chief medical officer of Onyx Pharmaceuticals. "Bayer and Onyx are committed to unlocking the potential of Nexavar in HCC in order to potentially improve the lives of patients at all stages and origins of this deadly disease."
Additional data include:
Biomarkers Predicting Outcome of Patients with Hepatocellular Carcinoma: Results from the Randomized Phase III SHARP Trial
Dr. Josep Llovet, Barcelona Clinic Liver Cancer (BCLC) Group, Liver Unit, CIBERehd, IDIBAPS, Hospital Clinic Barcelona, Barcelona, Spain; Mount Sinai Liver Cancer Program, Mount Sinai School of Medicine, New York.
Monday, November 3, 2008, 8:15 - 8:30 a.m. PDT, General Session Room
Abstract #149, Presidential Plenary
Identification of biomarkers predicting prognosis and/or response to treatment in patients with HCC may facilitate a more personalized approach to medicine. In a retrospective, exploratory analysis of a subset of the patients with HCC from the trial, investigators examined several biomarkers that may predict prognosis and/or response to treatment.
Nexavar's Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in more than 60 countries for liver cancer and in more than 70 countries for the treatment of patients with advanced kidney cancer. 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 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 other cancers, including metastatic melanoma, breast 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, 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 and 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, abdominal pain, 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 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.