2009 Press Releases

Bayer and Onyx Announce Nexavar Data Presentations at 60th American Association for the Study of Liver Diseases Annual Meeting

Wayne, NJ and Emeryville, CA. — Oct. 29, 2009

Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that more than 25 studies evaluating the use of Nexavar® (sorafenib) tablets in liver cancer will be presented at The Liver Meeting®, the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). Nexavar is the only systemic treatment to demonstrate prolonged survival in patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, and is currently approved in more than 80 countries for the treatment of the disease.

“Bayer and Onyx are committed to further evaluating Nexavar in patients with HCC to find the safest and most effective treatment regimens to help liver cancer patients better manage their disease,” said Mark Gelder, vice president, Bayer Global Medical Affairs, Oncology. “While we are encouraged by the role Nexavar has played in treating these patients, we continue to evaluate Nexavar in a variety of treatment settings, including in combination with TACE and other systemic therapies, and as a monotherapy in the adjuvant setting.”

Nexavar data highlights include:

Phase II Trial of Sorafenib Combined with Doxorubicin Eluting Bead-Transarterial Chemoembolization (DEB-TACE) for Patients with Hepatocellular Carcinoma (HCC): Interim Safety and Efficacy Analysis
  • Jean-Francois Henri Geschwind, The Johns Hopkins University School of Medicine, Baltimore, MD
  • Monday, November 2, 2009, 8:00 a.m. – 8:00 p.m., Exhibit Hall C
  • Late Breaker #9
 
First-in-men Demonstration of Sorafenib Plus TACE for the Treatment of Advanced Hepatocellular Carcinoma (SOCRATES trial)
  • Dr. Andreas Erhardt, Klinik für Gastroenterologie, Hepatologie und Infektiologie, Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany
  • Tuesday, November 3, 2009, 8:00 a.m. – 1:00 p.m., Exhibit Hall C
  • Abstract #1675
 
Efficacy and Safety of Sorafenib in Patients from the Asia-Pacific (AP) Region with Advanced Hepatocellular Carcinoma (HCC): Impact of Prior Transarterial Chemoembolization and Transarterial Embolization (TACE/TAE)
  • Dr. Zhendong Chen, First Affiliated Hospital of Anhui Medical University, Hefei, China
  • Tuesday, November 3, 2009, 8:00 a.m. – 1:00 p.m., Exhibit Hall C
  • Abstract #1694
 

“Liver cancer is often diagnosed at an advanced stage when patients tend to be very ill due to pre-existing liver disease,” said Todd Yancey, M.D., vice president of clinical development at Onyx. “Onyx and Bayer are committed to evaluating Nexavar in ongoing studies, as will be presented at AASLD, in order to realize the potential benefit the therapy may offer to patients at all stages of the disease and in different treatment settings.”

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, c-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 liver cancer 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. 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, 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.