WEST HAVEN, CT and EMERYVILLE, CA — Jun. 13, 2006
Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) announced today that Nexavar® (sorafenib) tablets has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic hepatocellular carcinoma (HCC), or liver cancer. Nexavar was approved by the FDA in December 2005 for the treatment of patients with advanced renal cell carcinoma (RCC).
The Fast Track program is designed to expedite the review of drug compounds for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need for new therapeutic approaches and where the product has the potential to demonstrate an effect on a serious or life-threatening aspect of the condition. Fast Track designation allows a company to file a New Drug Application (NDA) on a rolling basis as data become available. This permits the FDA to review the filing as it is received, rather than waiting for the entire document prior to commencing the review process. With Fast Track designation, there may be more frequent interactions with the FDA and there may be the possibility of a priority review, which could decrease the typical review period.
“We are pleased that Nexavar has received Fast Track designation by the FDA for this difficult-to-treat patient population, and we look forward to submitting our Phase III data when the analyses are complete,” said Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals Corporation.
A Phase III trial of Nexavar administered as a single agent to patients with advanced liver cancer is currently underway. Recently, this trial completed patient enrollment. The study is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression (TTP) of Nexavar versus placebo. A randomized Phase II trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is currently open and recruiting patients.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. It is the fifth most common cancer in the world. In 2002, approximately 626,000 HCC cases were reported worldwide, with 15,000 cases in the United States and 53,600 in Europe. HCC is most prevalent in developing countries, particularly in East and South-east Asia, the Pacific Basin, and sub-Saharan Africa. Of the 626,000 cases worldwide, approximately 410,000 were reported in Eastern Asia (with 346,000 in China and 40,000 in Japan alone). HCC causes more than 600,000 deaths annually worldwide. The five-year relative survival rate is about seven percent.
Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and tumor vasculature. In preclinical models, Nexavar targeted 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-2, VEGFR-3, PDGFR-β, KIT, and FLT-3.
Nexavar has been studied in more than 20 tumor types and in more than 8,000 clinical trial patients. It has demonstrated combinability with multiple anticancer agents. Nexavar is also being evaluated in Phase III clinical trials for the treatment of metastatic melanoma, or skin cancer, and non-small cell lung cancer (NSCLC). In addition to company-sponsored trials, there are a variety of Nexavar studies being sponsored by government agencies, cooperative groups and individual investigators.
Important Safety Considerations for U.S. Patients Taking Nexavar
Based on the currently approved package insert for the treatment of patients with 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. 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 treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar vs. 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 U.S. Nexavar prescribing information, visit www.nexavar.com or call 1.866.NEXAVAR (1.866.639.2827).
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer therapies that target the molecular basis of cancer. With its collaborators, the company is developing small molecule drugs, including Nexavar with Bayer Pharmaceuticals Corporation. For more information about Onyx’s pipeline and activities, visit the company’s web site at: www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.
Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is one of the world’s leading, innovative companies in the healthcare and medical products industry. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions. Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical Division, established January 1, 2006, which consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology; Oncology and Primary Care. Bayer HealthCare AG employed 33,800 people worldwide in 2005.
Bayer HealthCare AG’s aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statements
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 Bayer’s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including its Form 20-F). Bayer 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, 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, 2005, 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 Pharmaceuticals Corporation.Return to 2006 Press Releases