Bayer to Present New Data Across Oncology Portfolio at ASCO 2013

       Bayer to Present New Data Across Oncology Portfolio at ASCO 2013

PR Newswire

WAYNE, N.J., May 15, 2013

WAYNE, N.J., May 15, 2013 /PRNewswire/ -- Intended for U.S. Media
Only--Bayer HealthCare announced today that new data on the oncology
portfolio, including Nexavar® (sorafenib) tablets, Stivarga® (regorafenib)
tablets and the recently U.S. Food and Drug Administration (FDA) approved
product Xofigo® (radium Ra 223 dichloride) injection will be presented at the
49th Annual Meeting of the American Society of Clinical Oncology (ASCO), May
31 – June 4, in Chicago, IL (USA). These data showcase Bayer's commitment to
developing treatments for difficult-to-treat cancers.

"Bayer's oncology franchise has had a remarkable year of growth since ASCO
2012, receiving two drug approvals from the U.S. Food and Drug Administration
in three tumor types with high unmet medical need," said Pamela A. Cyrus, MD,
Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "At this year's ASCO, data presentations on Bayer's products
will highlight our continued commitment to making ongoing investments in areas
where therapeutic options are very much needed."

Notable studies evaluating Bayer's oncology products and compounds at ASCO
include:

Sorafenib

  oSorafenib in locally advanced or metastatic patients with radioactive
    iodine-refractory differentiated thyroid cancer: The phase III DECISION
    trial

       oAbstract #4, Plenary Abstract Session
       oSunday, June 2, 3:20-3:35 PM, N Hall B1

  oFinal analysis ofGIDEON (Global Investigation of Therapeutic Decisions in
    Hepatocellular Carcinoma [HCC] and of Its Treatment with Sorafenib [Sor])
    in >3000 Sor-treated patients (pts): Clinical findings in pts with liver
    dysfunction

       oAbstract #4126, General Poster Session: Gastrointestinal
         (Noncolorectal) Cancer
       oSunday, June 2, 8:00 - 11:45 AM, S Hall A2

Regorafenib

  oMutational analysis of plasma DNA from patients (pts) in the phase III
    GRID study of regorafenib (REG) versus placebo (PL) in tyrosine kinase
    inhibitor (TKI)-refractory GIST: Correlating genotype with clinical
    outcomes.

       oAbstract #10503, Oral Abstract Session: Sarcoma
       oMonday, June 3, 3:45-4:00 PM, S100bc

  oResults from a phase III trial (GRID) evaluating regorafenib (REG) in
    metastatic gastrointestinal stromal tumour (GIST): Subgroup analysis of
    outcomes based on pretreatment characteristics

       oAbstract #10551, General Poster Session: Sarcoma
       oSaturday, June 1, 1:15-5:00 PM, S Hall A2

  oTime profile of adverse events (AEs) from regorafenib (REG) treatment for
    metastatic colorectal cancer (mCRC) in the phase III CORRECT study

       oAbstract #3637, General Poster Session: Gastrointestinal (Colorectal)
         Cancer
       oSunday, June 2, 8:00-11:45 AM, S Hall A2

  oRegorafenib (REG) in progressive metastatic colorectal cancer (mCRC):
    Analysis of age subgroups in the phase III CORRECT trial

       oAbstract #3636, General Poster Session: Gastrointestinal (Colorectal)
         Cancer
       oSunday, June 2, 8:00-11:45 AM, S Hall A2

  oRegorafenib (REG) in patients with hepatocellular carcinoma (HCC)
    progressing following sorafenib: An ongoing randomized, double-blind,
    phase III trial

       oAbstract #TPS4163, General Poster Session: Gastrointestinal
         (Noncolorectal) Cancer
       oSunday, June 2, 8:00-11:45 AM, S Hall A2

  oAnalysis of plasma protein biomarkers from the CORRECT phase III study of
    regorafenib for metastatic colorectal cancer

       oAbstract #3514, Poster Discussion Session: Gastrointestinal
         (Colorectal) Cancer
       oTuesday, June 4, 8:00 AM - 12:00 PM, S405

Radium 223 dichloride

  oHematologic safety of Ra-223 dichloride (Ra-223) in castration-resistant
    prostate cancer (CRPC) patients with bone metastases from the phaseIII
    ALSYMPCA trial

       oAbstract #5060, General Poster Session: Genitourinary (Prostate)
         Cancer
       oMonday, June 3, 8:00 – 11:45 AM, S Hall A2

  oEfficacy and safety of radium-223 dichloride (Ra-223) in
    castration-resistant prostate cancer (CRPC) patients with bone metastases
    who did or did not receive prior docetaxel (D) in the phase III ALSYMPCA
    trial

       oAbstract #5068, General Poster Session: Genitourinary (Prostate)
         Cancer
       oMonday, June 3, 8:00 – 11:45 AM, S Hall A2

  oPain analysis from the phase III randomized ALSYMPCA study with radium-223
    dichloride (Ra-223) in castration-resistant prostate cancer (CRPC)
    patients with bone metastases

       oAbstract #5038, General Poster Session: Genitourinary (Prostate)
         Cancer
       oMonday, June 3, 8:00 – 11:45 AM, S Hall A2

  oCorrelation between baseline variables and survival in the radium-223
    dichloride (Ra-223) phase III ALSYMPCA trial with attention to total ALP
    changes

       oAbstract #5080, General Poster Session: Genitourinary (Prostate)
         Cancer
       oMonday, June 3, 8:00 – 11:45 AM, S Hall A2

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) 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.

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 to 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 patients
receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema. 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 Xofigo-treated patients (greater than or equal to 10%) were
anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

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 Pharmaceuticals Inc.

Website: http://www.bayer.com
Contact: Rose Talarico, +1 973 305 5302, Email: rose.talarico@bayer.com
 
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