March 18, 2017

Not intended for U.S. and UK Media - New Late-Breaking Study Data Presented at ACC.17:

Bayer's Rivaroxaban Demonstrated Superior Protection Against Recurrent Venous Thromboembolism Compared with Aspirin in EINSTEIN CHOICE Study

Study with more than 3,000 patients investigated rivaroxaban 10 mg and 20 mg once daily versus aspirin 100 mg once daily / Both rivaroxaban treatment arms were superior in preventing recurrent venous thromboembolism while showing comparable and very low rates of major bleeding versus aspirin / Risk of recurrent thrombosis is up to 10% in the first year if anticoagulation therapy is stopped / Data were presented in a late-breaking clinical trial session at ACC.17 and published simultaneously in The New England Journal of Medicine
Berlin, March 18, 2017 - Bayer AG and its development partner Janssen
Pharmaceuticals, Inc. today announced results from the EINSTEIN CHOICE study,
which demonstrated that both 10 mg and 20 mg once-daily dosages of its oral
Factor Xa inhibitor rivaroxaban (Xarelto®) significantly reduced the risk of
recurrent venous thromboembolism (VTE) compared with aspirin 100 mg once daily
(acetylsalicylic acid, ASA) in patients who had previously completed 6 to 12
months of anticoagulation therapy for pulmonary embolism (PE) or symptomatic
deep vein thrombosis (DVT). Importantly, patients with a definitive need for
continued therapeutic anticoagulation beyond the first 6 to 12 months were not
included in the study. Rivaroxaban 20 mg once daily (already approved treatment
regimen) significantly reduced the risk of recurrent VTE by 66% (relative risk
reduction) compared with aspirin 100 mg once daily, whilst rivaroxaban 10 mg
once daily significantly reduced the risk of recurrent VTE by 74% (relative
risk reduction) compared with aspirin 100 mg once daily. Both rivaroxaban
dosages demonstrated comparable and low major bleeding rates (the principal
safety outcome) on the same level as aspirin therapy. Results from EINSTEIN
CHOICE were presented today at 8 am EDT as a Late-Breaking Clinical Trial at
the American College of Cardiology (ACC) 66th Annual Scientific Session in
Washington DC and were simultaneously published in The New England Journal of
Medicine. Data from EINSTEIN CHOICE have been submitted to the European
Medicines Agency (EMA) and will be submitted to other Health Authorities
worldwide during the first half of 2017.

Venous thromboembolism, which includes pulmonary embolism and deep vein
thrombosis, is the third most common cause of cardiovascular death after heart
attack and stroke. In patients with VTE, anticoagulation therapy is recommended
for 3 months or longer, depending on the balance between the risk of recurrent
VTE and the risk of bleeding.

"In patients with unprovoked VTE or with ongoing risk factors, the risk of
recurrence is up to 10% in the first year if anticoagulation therapy is stopped
after 3, 6 or 12 months. But many physicians are reluctant to continue
anticoagulation therapy for longer durations because they are uncertain of the
benefit-risk balance for individual patients," said Jeffrey Weitz, Professor of
Medicine and Biochemistry and Biomedical Sciences, McMaster University, and
Executive Director of the Thrombosis and Atherosclerosis Research Institute,
Hamilton, Canada and Co-Chair of the EINSTEIN CHOICE Study. "The findings from
EINSTEIN CHOICE demonstrated exactly what the study name promised: once
approved, rivaroxaban 10 mg once daily will be available to physicians as an
additional choice in their armamentarium against recurrent VTE alongside the
already approved 20 mg once-daily dose. This flexibility of choices in
rivaroxaban doses will then enable physicians to use a precision approach to
selecting the most appropriate extended treatment based on assessment of
individual patient characteristics."

"EINSTEIN CHOICE is another example of Bayer's commitment to help answer
important medical questions that arise in daily clinical practice," said Dr
Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical
Division and Head of Development. "The EINSTEIN Clinical Development Programme,
including not only EINSTEIN CHOICE but also EINSTEIN PE, EINSTEIN DVT, and
EINSTEIN EXTENSION, has demonstrated the clinical utility of rivaroxaban in the
treatment and secondary prevention of venous thromboembolism. These new data
from EINSTEIN CHOICE add important additional insights on how best to provide
extended protection for patients with a VTE."

Also presented today during the same Late-Breaking Clinical Trials session at
ACC.17 and published simultaneously in The Lancet were results from the GEMINI
ACS 1 study - a double-blind Phase II study, which randomised 3,037 patients
with a recent ACS across 292 sites from 21 countries. The study met its primary
endpoint by showing that the combined antithrombotic regimen of rivaroxaban 2.5
mg twice daily in addition to background therapy of clopidogrel or ticagrelor
resulted in comparable rates of non-CABG TIMI clinically significant bleeding
as aspirin 100 mg once daily in combination with clopidogrel or ticagrelor.
Although the rates of the exploratory composite efficacy endpoint were also
similar across the treatment groups, GEMINI ACS 1 was not powered to assess the
impact on ischemic events.

EINSTEIN CHOICE and GEMINI ACS 1 add to the extensive investigation of
rivaroxaban, which, by the time of its completion, is expected to include more
than 275,000 patients in both clinical trials and real-world settings.

About EINSTEIN CHOICE

EINSTEIN CHOICE was a randomised, double-blind, superiority study comparing the
efficacy and safety of two doses of rivaroxaban (10 mg once daily and 20 mg
once daily) with aspirin (100 mg once daily) for the extended treatment of VTE
for up to one year in patients with objectively confirmed PE or symptomatic DVT
who had previously completed 6 to 12 months of anticoagulation therapy. Aspirin
was chosen as the comparator because aspirin 100 mg once daily has previously
been shown to reduce the risk of recurrent VTE by approximately 32% without
significantly increasing the risk of serious bleeding when compared with
placebo, findings which led to its inclusion in current guidelines.

A total of 3,396 patients were randomised from 244 sites in 31 countries.
Importantly, patients with a need for continued therapeutic anticoagulation
therapy were not included in the study as the objective of the study was to
investigate those patients for whom the treating physician was uncertain about
the need for continuing anticoagulation therapy at therapeutic doses.

The primary efficacy outcome was fatal or non-fatal symptomatic recurrent VTE
(composite of symptomatic recurrent VTE, VTE-related death and unexplained
death for which PE could not be excluded). The principal safety outcome was
major bleeding. Only the primary efficacy outcome comparison of rivaroxaban 20
mg vs aspirin and rivaroxaban 10 mg vs aspirin was powered for superiority.

EINSTEIN CHOICE demonstrated that rivaroxaban 20 mg once daily significantly
reduced the risk of recurrent VTE by 66% (relative risk reduction) compared
with aspirin (1.5% vs 4.4%; HR 0.34; 95% CI 0.20-0.59; p<0.001). Rivaroxaban 10
mg once daily significantly reduced the risk of recurrent VTE by 74% (relative
risk reduction) compared with aspirin (1.2% vs 4.4%; HR 0.26; 95% CI 0.14-0.47;
p<0.001). Rates of major bleeding were comparable and very low across all three
treatment arms at rates of 0.5% for rivaroxaban 20 mg once daily, 0.4% for
rivaroxaban 10 mg once daily and 0.3% in the aspirin group.

About Xarelto® (Rivaroxaban)

Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral
anticoagulant (NOAC) and is marketed under the brand name Xarelto®. Xarelto is
approved for seven indications, protecting patients across more venous and
arterial thromboembolic (VAT) conditions than any other NOAC:

- The prevention of stroke and systemic embolism in adult patients with
non-valvular atrial fibrillation (AF) with one or more risk factors

- The treatment of pulmonary embolism (PE) in adults

- The treatment of deep vein thrombosis (DVT) in adults

- The prevention of recurrent PE and DVT in adults

- The prevention of venous thromboembolism (VTE) in adult patients undergoing
elective hip replacement surgery

- The prevention of VTE in adult patients undergoing elective knee replacement
surgery

- The prevention of atherothrombotic events (cardiovascular death, myocardial
infarction or stroke) after an Acute Coronary Syndrome in adult patients with
elevated cardiac biomarkers and no prior stroke or transient ischaemic attack
(TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA
plus clopidogrel or ticlopidine

Whilst licences may differ from country to country, across all indications
Xarelto is approved in more than 130 countries.

Rivaroxaban was discovered by Bayer, and is being jointly developed with
Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by
Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research &
Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen
Pharmaceutical Companies of Johnson & Johnson).

Anticoagulant medicines are potent therapies used to prevent or treat serious
illnesses and potentially life-threatening conditions. Before initiating
therapy with anticoagulant medicines, physicians should carefully assess the
benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company
has developed a Prescribers Guide for physicians and a Xarelto Patient Card for
patients to support best practice.

To learn more, please visit https://prescribe.xarelto.com
To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com


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