Nexavar Data to Be Presented at American Society of Clinical Oncology Annual Meeting

WAYNE, N.J. and SOUTH SAN FRANCISCO, May 18, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that data evaluating the use of Nexavar® (sorafenib) tablets will be presented in a scientific forum at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), June 3-7, in Chicago.  

"Bayer and Onyx remain committed to researching the potential utility of sorafenib, and the number of abstracts being presented at this year's ASCO is a true testament to this commitment," said Dr. Dimitris Voliotis, Vice President, Global Clinical Development Oncology, Bayer HealthCare. "The companies look forward to continuing to work together, and with various institutions and study groups, to further explore sorafenib.  Sorafenib has demonstrated efficacy in patients with unresectable liver cancer and advanced kidney cancer, and we remain committed to determine the potential of this therapy for patients."

Bayer and Onyx-sponsored, Phase 2 and 3 studies, and other research evaluating sorafenib, including investigational uses, being presented at ASCO include:

Efficacy and safety of intra-patient dose escalation of sorafenib as first-line treatment for metastatic renal cell carcinoma (mRCC)

• Professor Martin Gore, Medical Director, The Royal Marsden and Professor of Cancer Medicine at The Institute of Cancer Research, United Kingdom
• Abstract number: 4609
• June 5, 8:00 am – 12:00 pm, General Poster Session

Sorafenib plus chemotherapy for patients with advanced breast cancer previously treated with bevacizumab.

• Clifford Hudis, M.D., Memorial Sloan-Kettering Cancer Center
• Abstract number: 1009
• June 6, 11:45 am, Oral Abstract Session

Design of RESILIENCE: A phase 3 trial comparing capecitabine in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer.

• Jose Baselga, M.D., Ph.D., Massachusetts General Hospital
• Abstract number: TPS123
• June 6, 8:00 am – 12:00 pm, Trials in Progress Poster Session

Development and validation of a prediction tool for hand-foot skin reaction (HFSR) in patients receiving sorafenib

• Jian Yu, M.D., University of Pittsburgh Cancer Institute
• Abstract number: 2605
• June 6, 8:00 am – 12:00 pm, General Poster Session

In addition, data from the Bayer and Onyx-sponsored Phase IV prospective study, GIDEON, which was accepted for Best of ASCO® 2011, will be presented:

GIDEON (Global investigation of Therapeutic Decisions in Hepatocellular Carcinoma [HCC] And Of Its Treatment with Sorafenib) 2nd interim analysis in more than 1500 Patients: clinical findings in patients with liver dysfunction

• Jorge Marrero, M.D., Associate Professor, Department of Internal Medicine, University of Michigan
• Abstract number: 4001
• June 7, 9:45 am, Oral abstract session

"There is a variety of abstracts evaluating the utility of sorafenib being presented at this year's ASCO," said Ted W. Love, M.D., Executive Vice President and Head of Research and Development and Technical Operations at Onyx Pharmaceuticals. "We look forward to continuing additional research in order to understand how sorafenib may fit into other therapeutic areas and tumor types."

About Nexavar

Nexavar is approved in the U.S. for the treatment of patients with unresectable liver cancer and for the treatment of patients with advanced kidney cancer. Nexavar inhibits both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit members of two classes of kinases thought 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 100 countries.

Nexavar is also being evaluated by the companies, international study groups, government agencies and individual investigators.

Important Safety Considerations For Patients Taking Nexavar

Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Nexavar may cause fetal harm when administered to a pregnant woman. Women of childbearing potential are advised to avoid becoming pregnant and female patients should also be advised against breastfeeding while receiving Nexavar

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar

Uncommon but serious adverse reactions, including keratoacanthomas/squamous cell cancer of the skin and Stevens-Johnson Syndrome, have been reported in clinical trials

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar

Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Caution is recommended when administering Nexavar with compounds that are metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1 pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers. Concomitant use of carboplatin and paclitaxel with sorafenib resulted in an increase in paclitaxel exposure and an increase in Nexavar exposure. Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes. Nexavar exposure decreases when coadministered with oral neomycin. Effects of other antibiotics on Nexavar pharmacokinetics have not been studied

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%), and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%

During postapproval use of Nexavar, the following adverse drug reactions have been identified: angioedema and drug-induced hepatitis, including reports of hepatic failure and death

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 business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals provides products for Diagnostic Imaging, General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. 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 that is currently approved for the treatment of liver cancer and advanced kidney cancer. Additionally, Nexavar is being investigated in several ongoing trials in a variety of tumor types. Beyond Nexavar, Onyx has established a development pipeline of anticancer compounds at various stages of clinical testing, including carfilzomib, a next generation proteasome inhibitor, that is currently being evaluated in multiple clinical trials for the treatment of patients with relapsed or relapsed/refractory multiple myeloma and solid tumors. ONX 0801, an alpha-folate receptor targeted inhibitor of the thymidylate synthase, and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. 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 website 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 contains "forward-looking statements" of Onyx within the meaning of the federal securities laws. These forward-looking statements include without limitation, statements regarding the 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, including risks related to the development and commercialization of pharmaceutical products. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Reference should be made to Onyx's Annual Report on Form 10-K for the year ended December 31, 2010, 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.

Bayer (reg'd), the Bayer cross (reg'd) and Nexavar® (sorafenib) tablets are registered trademarks of Bayer.

SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals, Inc.

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