Data from Bayer Oncology Portfolio and Pipeline to be Presented at ASCO 2014
WHIPPANY, N.J., May 14, 2014 /PRNewswire/ — Bayer HealthCare Pharmaceuticals Inc. announced today that data from its oncology portfolio, including NEXAVAR(®) (sorafenib) tablets, Xofigo(®) (radium Ra 223 dichloride) injection and Stivarga(®) (regorafenib) tablets, will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 – June 3, in Chicago, IL (USA). Bayer will also present data from its late stage clinical pipeline, investigating compounds in solid tumors, including pancreatic cancer.
“In the past two years, Bayer has made remarkable progress in oncology, with three approved products, a robust clinical pipeline and dozens of collaborations with top academic and industry leaders,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We plan to continue this success by exploring where our existing therapies and pipeline compounds might be applied in other tumor types, in combination with other treatments or in different sequences.”
Notable studies evaluating Bayer’s oncology products and compounds at ASCO 2014 are listed below.
-- Updated overall survival analysis of patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAI-rDTC) treated with sorafenib on the phase 3 DECISION trial -- Abstract #6060, General Poster Session: Head and Neck Cancer -- Saturday, May 31, 1:15 - 5:00 PM, S Hall A2 -- Population PK modeling and exposure-response analyses of sorafenib in patients with radioactive iodine-refractory differentiated thyroid cancer (RAI-rDTC) in the phase III DECISION trial -- Abstract #6061, General Poster Session: Head and Neck Cancer -- Saturday, May 31, 1:15 - 5:00 PM, S Hall A2 -- Safety and tolerability of sorafenib for treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAI-rDTC): Detailed analyses from the phase III DECISION trial -- Abstract #6062, General Poster Session: Head and Neck Cancer -- Saturday, May 31, 1:15 - 5:00 PM, S Hall A2 -- Final analysis of European patients from the Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of its Treatment with Sorafenib (GIDEON) study: Baseline characteristics and staging systems -- Abstract #4088, General Poster Session: Gastrointestinal (Noncolorectal) Cancer -- Saturday, May 31, 8:00 - 11:45 AM, S Hall A2 -- OPTIMIS: An international observational study to assess the use of sorafenib after transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC) -- Abstract #TPS4155, General Poster Session: Gastrointestinal (Noncolorectal) Cancer -- Saturday, May 31, 8:00 - 11:45 AM, S Hall A2 -- Biomarker analyses and association with clinical outcomes in patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib with or without erlotinib in the phase III SEARCH trial. -- Abstract #4028, Poster Highlights Session: Gastrointestinal (Noncolorectal) Cancer -- Sunday, June 1, 8:00 - 11:00 AM, E354b -- STORM: A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (HCC) -- Abstract #4006, Oral Abstract Session: Gastrointestinal (Noncolorectal) Cancer -- Monday, June 2, 2:51 - 3:03 PM, E Hall D1
Radium Ra 223 Dichloride
-- Patient-reported quality of life (QOL) analysis of radium-223 dichloride (Ra-223) evaluating pain relief from the phase 3 ALSYMPCA study -- Abstract #5069, General Poster Session: Genitourinary (Prostate) Cancer -- Monday, June 2, 1:15 - 5:00 PM, S Hall A2 -- 1.5-year post-treatment follow-up of radium-223 dichloride (Ra-223) safety in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases from the phase 3 ALSYMPCA study -- Abstract #5070, General Poster Session: Genitourinary (Prostate) Cancer -- Monday, June 2, 1:15 - 5:00 PM, S Hall A2 -- A randomized open-label phase 2a study evaluating the efficacy and safety of radium-223 dichloride (Ra-223) in combination with abiraterone acetate or enzalutamide in patients with castration-resistant prostate cancer (CRPC) and bone metastases -- Abstract #TPS5103, General Poster Session: Genitourinary (Prostate) Cancer -- Monday, June 2, 1:15 - 5:00 PM, S Hall A2
-- RESORCE: An ongoing randomized, double-blind, phase III trial of regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing on sorafenib (SOR) -- Abstract #TPS4156, General Poster Session: Gastrointestinal (Noncolorectal) Cancer -- Saturday, May 31, 8:00 - 11:45 AM, S Hall A2 -- The relationship between overall survival (OS) and progression-free survival (PFS) in gastrointestinal stromal tumor (GIST) -- Abstract #10557, General Poster Session: Sarcoma -- Monday, June 2, 8:00 - 11:45 AM, S Hall A2
-- Phase II study of the MEK inhibitor refametinib (BAY 86-9766) in combination with gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer: Biomarker results -- Abstract #4129, General Poster Session: Gastrointestinal (Noncolorectal) Cancer -- Saturday, May 31, 8:00 - 11:45 AM, S Hall A2 -- A phase 1b trial of PI3K inhibitor copanlisib (BAY 80-6946) combined with the allosteric-MEK inhibitor refametinib (BAY 86-9766) in patients with advanced cancer -- Abstract #2588, General Poster Session: Developmental Therapeutics -- Sunday, June 1, 8:00 - 11:45 AM, S Hall A2 -- Phase 1 dose escalation study of copanlisib (BAY 80-6946) in combination with gemcitabine or gemcitabine-cisplatin in advanced cancer patients -- Abstract #2610, General Poster Session: Developmental Therapeutics -- Sunday, June 1, 8:00 - 11:45 AM, S Hall A2 -- Phase II study of refametinib (BAY 86-9766), an allosteric dual MEK 1/2 inhibitor, and gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer -- Abstract #4025, Poster Highlights Session: Gastrointestinal (Noncolorectal) Cancer -- Sunday, June 1, 8:00 - 11:00 AM, E354b
About NEXAVAR® (sorafenib) Tablets
NEXAVAR is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. Nexavar is thought to inhibit both the tumor cell and tumor vasculature.( )In in vitro 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.
Nexavar is co-developed by Onyx and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.
Important Safety Considerations For Nexavar® (sorafenib) Tablets
Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer.
Cardiac ischemia and/or myocardial infarction may occur. The incidence of cardiac ischemia/infarction in Nexavar-treated vs. placebo-treated patients was 2.7% vs. 1.3%, 2.9% vs. 0.4%, and 1.9% vs. 0% in the HCC, RCC, and DTC studies, respectively. 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. The following bleeding adverse reactions were reported in the Nexavar-treated vs. placebo-treated patients, respectively, in the HCC study: bleeding from esophageal varices (2.4% vs. 4%) and bleeding with fatal outcome at any site (2.4% vs. 4%); in the RCC study: bleeding regardless of causality (15.3% vs. 8.2%), Grade 3 bleeding (2.0% vs. 1.3%), Grade 4 bleeding (0% vs. 0.2%), and one fatal hemorrhage in each treatment group; in the DTC study: bleeding (17.4% vs. 9.6%) and Grade 3 bleeding (1% vs. 1.4%). 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. Interrupt Nexavar if QTc interval is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater.
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.
In DTC, Nexavar impairs exogenous thyroid suppression. Elevation of thyroid stimulating hormone (TSH) level above 0.5 mU/L was observed in 41% of Nexavar-treated patients as compared with 16% of placebo-treated patients in the DTC study. Monitor TSH levels monthly and adjust thyroid replacement medication as needed in patients with DTC.
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 sorafenib. 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%.
Most common adverse reactions reported for Nexavar -treated patients vs. placebo-treated patients in DTC, respectively, were: Palmar-plantar erythrodysesthesia syndrome (PPES) (69% vs. 8%), diarrhea (68% vs. 15%), alopecia (67% vs. 8%), weight loss (49% vs. 14%), fatigue (41% vs. 20%), hypertension (41% vs. 12%), rash (35% vs. 7%), decreased appetite (30% vs. 5%), stomatitis (24% vs. 3%), nausea (21% vs. 12%), pruritus (20% vs. 11%), and abdominal pain (20% vs. 7%). Grade 3/4 adverse reactions were 65% vs. 30%.
For information about Nexavar including U.S. Nexavar prescribing information, visit www.NEXAVAR-us.com or call 1.866.Nexavar (1.866.639.2827).( )
About Xofigo(®) (radium Ra 223 dichloride) Injection
Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium Ra 223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.()
Important Safety Information for Xofigo(®) (radium Ra 223 dichloride) Injection
-- Contraindications: Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman. -- Bone Marrow Suppression: In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression - notably thrombocytopenia, neutropenia, pancytopenia, and leucopenia - has been reported in patients treated with Xofigo. Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure. -- Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than or equal to 1.5 × 10(9)/L, the platelet count greater than or equal to 100 × 10(9)/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10(9)/L and the platelet count greater than or equal to 50 × 10(9)/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care. -- Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued. -- Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations. -- Adverse Reactions: The most common adverse reactions (³10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (³10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%).
For full prescribing information visit http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf.
About Stivarga (regorafenib)
In the United States, Stivarga is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate.()
Stivarga is an inhibitor of multiple kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis and maintenance of the tumor microenvironment.()
Stivarga is a compound developed by Bayer. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary (NASDAQ: AMGN), under which Onyx receives a royalty on all global net sales of Stivarga in oncology.
Important Safety Information for Stivarga(®) (regorafenib) tablets:
-- Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. -- Monitor hepatic function prior to and during treatment. -- Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
Severe drug-induced liver injury with fatal outcome occurred in 0.3% of 1200 Stivarga-treated patients across all clinical trials. In metastatic colorectal cancer (mCRC), fatal hepatic failure occurred in 1.6% of patients in the Stivarga arm and in 0.4% of patients in the placebo arm; all the patients with hepatic failure had metastatic disease in the liver. In gastrointestinal stromal tumor (GIST), fatal hepatic failure occurred in 0.8% of patients in the Stivarga arm.
Obtain liver function tests (ALT, AST, and bilirubin) before initiation of Stivarga and monitor at least every 2 weeks during the first 2 months of treatment. Thereafter, monitor monthly or more frequently as clinically indicated. Monitor liver function tests weekly in patients experiencing elevated liver function tests until improvement to less than 3 times the upper limit of normal (ULN) or baseline values. Temporarily hold and then reduce or permanently discontinue Stivarga, depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.
Stivarga caused an increased incidence of hemorrhage. The overall incidence (Grades 1-5) was 21% and 11% with Stivarga vs 8% and 3% with placebo in mCRC and GIST patients, respectively. Fatal hemorrhage occurred in 4 of 632 (0.6%) Stivarga -treated patients and involved the respiratory, gastrointestinal, or genitourinary tracts. Permanently discontinue Stivarga in patients with severe or life-threatening hemorrhage and monitor INR levels more frequently in patients receiving warfarin.
Stivarga caused an increased incidence of hand-foot skin reaction (HFSR) (also known as palmar-plantar erythrodysesthesia [PPE]) and severe rash, frequently requiring dose modification. The overall incidence was 45% and 67% with Stivarga vs 7% and 12% with placebo in mCRC and GIST patients, respectively. Incidence of Grade 3 HFSR (17% vs 0% in mCRC and 22% vs 0% in GIST), Grade 3 rash (6% vs <1% in mCRC and 7% vs 0% in GIST), serious adverse reactions of erythema multiforme (0.2% vs 0% in mCRC), and Stevens-Johnson syndrome (0.2% vs 0% in mCRC) was higher in Stivarga-treated patients. Toxic epidermal necrolysis occurred in 0.17% of 1200 Stivarga -treated patients across all clinical trials. Withhold Stivarga, reduce the dose, or permanently discontinue depending on the severity and persistence of dermatologic toxicity.
Stivarga caused an increased incidence of hypertension (30% vs 8% in mCRC and 59% vs 27% in GIST with Stivarga vs placebo, respectively). Hypertensive crisis occurred in 0.25% of 1200 Stivarga-treated patients across all clinical trials. Do not initiate Stivarga until blood pressure is adequately controlled. Monitor blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Temporarily or permanently withhold Stivarga for severe or uncontrolled hypertension.
Stivarga increased the incidence of myocardial ischemia and infarction in mCRC (1.2% with Stivarga vs 0.4% with placebo). Withhold Stivarga in patients who develop new or acute cardiac ischemia or infarction, and resume only after resolution of acute cardiac ischemic events if the potential benefits outweigh the risks of further cardiac ischemia.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurred in 1 of 1200 Stivarga-treated patients across all clinical trials. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Confirm the diagnosis of RPLS with MRI and discontinue Stivarga in patients who develop RPLS.
Gastrointestinal perforation or fistula occurred in 0.6% of 1200 patients treated with Stivarga across clinical trials. In GIST, 2.1% (4/188) of Stivarga-treated patients developed gastrointestinal fistula or perforation: of these, 2 cases of gastrointestinal perforation were fatal. Permanently discontinue Stivarga in patients who develop gastrointestinal perforation or fistula.
Treatment with Stivarga should be stopped at least 2 weeks prior to scheduled surgery. Resuming treatment after surgery should be based on clinical judgment of adequate wound healing. Stivarga should be discontinued in patients with wound dehiscence.
Stivarga can cause fetal harm when administered to a pregnant woman. Use effective contraception during treatment and up to 2 months after completion of therapy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Stivarga, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
The most frequently observed adverse drug reactions (greater than or equal to 30%) in Stivarga-treated patients vs placebo-treated patients in mCRC, respectively, were: asthenia/fatigue (64% vs 46%), decreased appetite and food intake (47% vs 28%), HFSR/PPE (45% vs 7%), diarrhea (43% vs 17%), mucositis (33% vs 5%), weight loss (32% vs 10%), infection (31% vs 17%), hypertension (30% vs 8%), and dysphonia (30% vs 6%).
The most frequently observed adverse drug reactions (greater than or equal to 30%) in Stivarga-treated patients vs placebo-treated patients in GIST, respectively, were: HFSR/PPE (67% vs 15%), hypertension (59% vs 27%), asthenia/fatigue (52% vs 39%), diarrhea (47% vs 9%), mucositis (40% vs 8%), dysphonia (39% vs 9%), infection (32% vs 5%), decreased appetite and food intake (31% vs 21%), and rash (30% vs 3%).
For full prescribing information, including BOXED WARNING, visit www.stivarga-us.com.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
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 Pharmaceuticals Inc. 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.
© 2014 Bayer HealthCare Pharmaceuticals Inc.
BAYER, the Bayer Cross, Nexavar, Stivarga and Xofigo are registered trademarks of Bayer.
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.
 NEXAVAR(R) (sorafenib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, November 2013.  XOFIGO(R) (radium Ra 223 dichloride) [Prescribing Information]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, May 2013.  STIVARGA(R) (regorafenib) [Prescribing Information]. Wayne, NJ: Bayer HealthCare Pharmaceuticals, August 2013.
SOURCE Bayer HealthCare