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Phase 3 DECISION Trial of Nexavar® (sorafenib) Meets Primary Endpoint of Improving Progression-Free Survival in Patients with Radioactive Iodine Refractory Differentiated Thyroid Cancer

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., Jan. 3, 2013 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial of Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Nexavar compared to placebo. Adverse events were generally consistent with the known profile for Nexavar. Data from this study are expected to be presented at an upcoming medical meeting.

"These results demonstrate Nexavar's activity in patients with RAI-refractory locally advanced, or metastatic differentiated thyroid cancer," said Dimitris Voliotis, M.D., Vice President, Global Clinical Development Oncology, Bayer HealthCare. "These types of thyroid cancer are difficult to treat and are associated with a poor prognosis." 

"Effective treatment options are urgently needed for patients with radioactive iodine-refractory differentiated thyroid cancer," said Barbara Klencke, M.D., Senior Vice President, Clinical Development at Onyx Pharmaceuticals. "We are pleased that the results of this study demonstrate that Nexavar may provide a treatment option for these patients."

The companies anticipate that this data will form the basis for regulatory submission of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer.

About the DECISION Trial

The DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial was an international, multicenter, randomized, placebo-controlled study that randomized 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer (papillary, follicular, Hurthle cell and poorly differentiated) who had received no prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor, or other targeted agents for thyroid cancer. Patients were randomized to receive 400 mg of oral Nexavar twice daily or matching placebo. At the time of progression, patients receiving placebo had the option to cross over to Nexavar at the discretion of the investigator, based on the patient's clinical status. The primary endpoint of the study was progression-free survival, as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included overall survival, time to progression, response rate and duration of response. Safety and tolerability were also evaluated.

About Thyroid Cancer

Thyroid cancer, one of the few cancers that has increased in incidence over the past several years, is the sixth most common cancer in women, with about three times as many women as men diagnosed.[1] There are more than 160,000 new cases of thyroid cancer and approximately 25,000 people die worldwide each year.[2]

Papillary, follicular and Hurthle cell types of thyroid cancer are classified as "differentiated thyroid cancer" and account for the vast majority of thyroid cancers. While the majority of differentiated thyroid cancers are treatable, RAI-refractory, locally advanced, or metastatic disease is more difficult to treat and is associated with a lower survival rate.[1]

About Nexavar (sorafenib) Tablets

Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. Nexavar is thought to inhibit both the tumor cell and tumor vasculature. In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is currently approved in more than 100 countries.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.

Important Safety Considerations For Nexavar (sorafenib)
Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

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

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider permanent 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, if 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. Nexavar should be discontinued if Stevens-Johnson Syndrome or toxic epidermal necrolysis are suspected as these may be life threatening.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar. Discontinue Nexavar in the event of a gastrointestinal perforation

Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time (PT), International Normalized Ratio (INR) or clinical bleeding episodes

Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures

Nexavar in combination with gemcitabine/cisplatin is not recommended in patients with squamous cell lung cancer. The safety and effectiveness of Nexavar has not been established in patients with non-small cell lung cancer

Nexavar can prolong the QT/QTc interval and increase the risk for ventricular arrhythmias. Avoid use in patients with congenital long QT syndrome and monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities

Drug-induced hepatitis with Nexavar may result in hepatic failure and death. Liver function tests should be monitored regularly and in cases of increased transaminases without alternative explanation Nexavar should be discontinued

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

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar

Avoid concomitant use of strong CYP3A4 inducers, when possible, because inducers can decrease the systemic exposure of Nexavar. Nexavar exposure decreases when co-administered 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%.

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, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare provides products for 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.
Based in South San Francisco, California, Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways. For more information about Onyx, visit the company's website at www.onyx.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 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, 2011, 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.

[1]  American Cancer Society. Thyroid Cancer: http://www.cancer.org/Cancer/ThyroidCancer/DetailedGuide/thyroid-cancer-key-statistics

[2]  Globocan 2008: http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900

SOURCE Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.

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