April 28, 2017

Not Intended for U.S. or UK Media

Bayer Receives FDA Approval for Stivarga® (regorafenib) for the Second-Line Systemic Treatment of Liver Cancer

Stivarga is the first and only systemic treatment to demonstrate significant improvement in overall survival in second-line hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib) / First new treatment for HCC in a decade / Pivotal Phase III RESORCE trial defines a new treatment plan in HCC which involves use of Stivarga directly after progression on Nexavar
Berlin, April 28, 2017 - Bayer announced today that the U.S. Food and Drug
Administration (FDA) approved Stivarga® (regorafenib) tablets for the
second-line treatment of patients with hepatocellular carcinoma (HCC) who have
been previously treated with Nexavar® (sorafenib). Stivarga is the first and
only treatment to demonstrate significant improvement in overall survival in
second-line HCC patients. In the RESORCE trial, Stivarga was shown to provide a
statistically significant and clinically meaningful improvement in overall
survival (OS) versus placebo; the median OS was 10.6 [(n=379) (CI 9.1, 12.1)]
vs 7.8 [(n=194) (CI 6.3, 8.8)] months, respectively (HR 0.63, 95% CI 0.50-0.79;
p<0.0001). This translates to a 37% reduction in the risk of death. The number
of deaths in each arm included 233 of 379 (62%) with Stivarga and 140 of 194
(72%) with placebo. Today's FDA approval expands Bayer's leadership in liver
cancer with a treatment plan in HCC involving use of Stivarga directly after
progression on Nexavar.

Stivarga is an oral inhibitor of multiple kinases involved in normal cellular
functioning and in pathological processes such as oncogenesis, tumor
angiogenesis, metastasis and tumor immunity. The FDA's approval is based on
data from the international, multicenter, placebo-controlled Phase III RESORCE
[REgorafenib after SORafenib in patients with hepatoCEllular carcinoma; NCT
01774344] trial, which investigated patients with HCC whose disease had
progressed during treatment with Nexavar. The most frequently observed adverse
drug reactions (?30%) in patients treated with regorafenib vs. placebo-treated
patients in HCC, respectively, were: pain (55% vs. 44%), HFSR/PPE (51% vs. 7%),
asthenia/fatigue (42% vs. 33%), diarrhea (41% vs. 15%), hypertension (31% vs.
6%), infection (31% vs. 18%), decreased appetite and food intake (31% vs. 15%).

"Hepatocellular carcinoma is very hard to treat, and with no new treatments in
nearly a decade, options have been very limited for physicians and patients,"
said Dr Jordi Bruix, lead investigator for the RESORCE trial, BCLC Group, Liver
Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBEREHD, Spain. "The
U.S. approval of Stivarga for hepatocellular carcinoma therefore provides a
significant step forward in addressing the high unmet need in this patient

The incidence of liver cancer is increasing worldwide and it is already the
sixth most common cancer in the world and the second leading cause of
cancer-related deaths globally.

"Bayer is proud to have played a significant role in the treatment of
hepatocellular carcinoma," said Robert LaCaze, executive vice president and
head of the Oncology Strategic Business Unit at Bayer. "We first embarked on
our scientific research in this area 20 years ago. We could not have done it
alone: we would like to thank the patients, caregivers and investigators for
their participation and engagement in the RESORCE trial."

The approval of Stivarga in liver cancer marks the third time that this therapy
has been granted FDA approval on a priority basis. The FDA granted Fast Track
designation to Stivarga in HCC, which is an expedited program designed to
facilitate development and review of drugs to address an unmet medical need in
the treatment of a serious or life-threatening condition. The FDA also granted
Orphan Drug Designation (ODD) to Stivarga in HCC. The ODD program provides
orphan status to drugs and biologics which are defined as those intended for
the safe and effective treatment, diagnosis or prevention of rare diseases and
disorders. Additional regulatory filings for Stivarga in HCC are under review
in countries around the world, including the EU, Japan and China. Decisions in
the EU and Japan regions are expected later this year.

About Hepatocellular Carcinoma

Hepatocellular carcinoma, or HCC, is the most common form of liver cancer and
represents approximately 70-85 percent of liver cancer worldwide. More than
780,000 cases of liver cancer are diagnosed worldwide each year (52,000 in the
European Union, 501,000 in the Western Pacific region and 30,000 in the United
States). In 2012, approximately 746,000 people died of liver cancer including
approximately 48,000 in the European Union, 477,000 in the Western Pacific
region and 24,000 in the United States.

About Regorafenib (Stivarga®)

Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple
protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2),
oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor
immunity (CSF1R).

Regorafenib is already approved under the brand name Stivarga® in more than 90
countries worldwide, including the U.S., countries of the EU, China and Japan
for the treatment of mCRC. The product is also approved in over 80 countries,
including the U.S., countries of the EU, China and Japan, for the treatment of
metastatic GIST. In April 2017, Stivarga was approved in the U.S. for use in
patients with HCC who have been previously treated with sorafenib. In the U.S.,
Stivarga is already 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 RAS 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. In the EU, Stivarga is
indicated for the treatment of adult patients with mCRC who have been
previously treated with, or are not considered candidates for, available
therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy
and an anti-EGFR therapy, as well as for the treatment of adult patients with
unresectable or metastatic GIST who progressed on or are intolerant to prior
treatment with imatinib and sunitinib.

Regorafenib is a compound developed by Bayer. In 2011, Bayer entered into an
agreement with Onyx, now an Amgen subsidiary, under which Onyx receives a
royalty on all global net sales of regorafenib in oncology.

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 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.

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields
of health care and agriculture. Its products and services are designed to
benefit people and improve their quality of life. At the same time, the Group
aims to create value through innovation, growth and high earning power. Bayer
is committed to the principles of sustainable development and to its social and
ethical responsibilities as a corporate citizen. In fiscal 2016, the Group
employed around 115,200 people and had sales of EUR 46.8 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.7 billion.
These figures include those for the high-tech polymers business, which was
floated on the stock market as an independent company named Covestro on October
6, 2015. For more information, go to www.bayer.com.

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