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Bayer to Present Data on Multiple Oncology Compounds at the European Cancer Congress (ECCO-ESMO-ESTRO) 2013

 Bayer to Present Data on Multiple Oncology Compounds at the European Cancer
                       Congress (ECCO-ESMO-ESTRO) 2013

PR Newswire

WHIPPANY, N.J., Sept. 17, 2013

WHIPPANY, N.J., Sept. 17, 2013 /PRNewswire/ --Bayer HealthCare announced
today that data from the company's oncology portfolio, including Nexavar^®
(sorafenib) tablets, Stivarga^® (regorafenib) tablets and Xofigo^® (radium Ra
223 dichloride) injection will be presented at the 2013 European Cancer
Congress (ECCO/ESMO/ESTRO), September 28 – October 1, in Amsterdam,
Netherlands. These data include an oral presentation of a subanalysis from the
Phase III trial of sorafenib in patients with radioactive iodine-refractory
differentiated thyroid cancer, an oral presentation and posters on the
efficacy and safety of regorafenib, which was recently approved by the
European Medicines Agency (EMA), and posters on additional analyses from the
pivotal ALSYMPCA trial of radium 223, which was recently approved by the FDA
for the treatment of castration-resistant prostate cancer patients,
symptomatic bone metastases and no known visceral metastates.

"In the past year, Bayer has transformed its oncology business into a
multi-product franchise, expanding the portfolio to include two additional
products in three indications addressing unmet medical needs," said Svetlana
Kobina, MD, PhD-VP, Head Global Medical Affairs, Bayer HealthCare
Pharmaceuticals. "Along with the data being presented at the European Cancer
Congress, the recent approvals of radium 223 in the U.S. and regorafenib in
the European Union illustrate our continued dedication to advancing treatment
options for patients."

Sorafenib

  oAssociation between tumor BRAF and RAS mutation status and clinical
    outcomes in patients with radioactive iodine (RAI)-refractory
    differentiated thyroid cancer (DTC) randomized to sorafenib or placebo:
    sub-analysis of the phase III DECISION trial

       oAbstract #3155, Oral Presentation, Proffered Papers Session: Head and
         Neck Cancer
       oSaturday, September 28, 17:02 PM CEST, Hall 3.1

Regorafenib

  oEffects of regorafenib therapy on health-related quality of life in
    patients with metastatic colorectal cancer in the phase III CORRECT study

       oAbstract #2156, Oral Presentation, Proffered Paper Session:
         Gastrointestinal Malignancies – Colorectal Cancer II
       oSunday, September 29, 9:00AM CEST, RAI Auditorium

  oRegorafenib dose modifications in patients with metastatic colorectal
    cancer in the phase III CORRECT study

       oAbstract #2360, Poster Session: Gastrointestinal Malignancies –
         Colorectal Cancer
       oSunday, September 29, 2:00-4:30 PM CEST, Hall 4

  oTime to health status deterioration in regorafenib-treated patients with
    metastatic colorectal cancer (mCRC): a post-hoc analysis of the phase III
    CORRECT study

       oAbstract #2361, Poster Session: Gastrointestinal Malignancies –
         Colorectal Cancer
       oSunday, September 29, 2:00-4:30 PM CEST, Hall 4

  oTranscript profiling of patient-derived (PD) colorectal cancer (CRC)
    xenografts for the identification of biomarkers for regorafenib (REG; BAY
    73-4506)

       oAbstract #2408, Poster Session: Gastrointestinal Malignancies –
         Colorectal Cancer
       oSunday, September 29, 2:00-4:30 PM CEST, Hall 4

  oTime course of adverse events in the phase III GRID study of regorafenib
    in patients with metastatic gastrointestinal stromal tumors (GIST)

       oAbstract #3827, Poster Session: Sarcoma: Soft Tissue and Bone
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

  oHealth-related quality of life (HRQoL) of patients with advanced
    gastrointestinal stromal tumors (GIST) treated with regorafenib (REG) vs
    placebo (P) in the phase III GRID trial

       oAbstract #3830, Poster Session: Sarcoma: Soft Tissue and Bone
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

  oExposure-efficacy analysis of regorafenib (REG) and its metabolites M-2
    and M-5 in the phase III GRID study in patients (pts) with metastatic
    gastrointestinal stromal tumor (GIST)

       oAbstract #3831, Poster Session: Sarcoma: Soft Tissue and Bone
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

Radium 223 dichloride

  oTime to first skeletal-related event (SRE) with radium-223 dichloride
    (Ra-223) in patients with castration-resistant prostate cancer (CRPC) and
    bone metastases: ALSYMPCA trial stratification factors analysis

       oAbstract #2876, Poster Session: Genitourinary Malignancies - Prostate
         Cancer
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

  oHematologic safety of radium-223 dichloride (Ra-223) in the phase 3
    ALSYMPCA trial in castration-resistant prostate cancer (CRPC) patients
    with bone metastases: baseline prognostic factor subgroup analysis

       oAbstract #2877, Poster Session: Genitourinary Malignancies - Prostate
         Cancer
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

  oEffects of radium-223 dichloride (Ra-223) on health-related quality of
    life (QOL) outcomes in the phase 3 ALSYMPCA study in patients with
    castration-resistant prostate cancer (CRPC) and bone metastases

       oAbstract #2878, Poster Session: Genitourinary Malignancies - Prostate
         Cancer
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

  oRadium-223 dichloride (Ra-223) efficacy and safety in patients with
    castration-resistant prostate cancer (CRPC) with bone metastases: phase 3
    ALSYMPCA study findings stratified by age group

       oAbstract #2883, Poster Session: Genitourinary Malignancies - Prostate
         Cancer
       oMonday, September 30, 9:30 AM-12:00 PM CEST, Hall 4

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 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.

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. 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
childbearing 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 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%.

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 Stivarga® (regorafenib) Tablets
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 gastrointestinal stromal tumor
(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 Bayer compound developed by Bayer and jointly promoted by Bayer
and Onyx in the United States. In 2011, Bayer entered into an agreement with
Onyx, under which Onyx receives a royalty on all global net sales of Stivarga
in oncology.

For full prescribing information, including BOXED WARNING, visit
www.stivarga-us.com.

Important Safety Information For Stivarga® (regorafenib) Tablets

WARNING: HEPATOTOXICITY

  oSevere and sometimes fatal hepatotoxicity has been observed in clinical
    trials.
  oMonitor hepatic function prior to and during treatment.
  oInterrupt 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 (>/=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 (>/=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 Xofigo^® (radium Ra 223 dichloride) Injection
Xofigo is indicated for the treatment of patients with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral metastatic
disease.

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-223
dichloride is less than 100 micrometers which may limit the damage to the
surrounding normal tissue.

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway)
for the development and commercialization of Xofigo. Under the terms of the
agreement, Bayer will develop, apply for health authority approvals worldwide
and commercialize Xofigo globally.

Important Safety Information for Xofigo^® (radium Ra 223 dichloride) Injection
Xofigo is contraindicated in women who are or may become pregnant. Xofigo can
cause fetal harm when administered to a pregnant woman.

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 (less than 1%) was similar for patients treated with Xofigo and
placebo. Myelosuppression – notably thrombocytopenia, neutropenia,
pancytopenia, and leukopenia – 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.

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.

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.

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.

The most common adverse reactions (greater than or equal to 10%) 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 (greater than or equal to 10%) 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 www.xofigo-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 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.

Nexavar^®, Stivarga^®, Xofigo^®, Bayer^® and the Bayer Cross^® are registered
trademarks of Bayer.

Forward-Looking Statement
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.

SOURCE Bayer HealthCare

Website: http://www.bayer.com
Contact: Rose Talarico, +1 862 404 5302, Email: rose.talarico@bayer.com