March 06, 2017

Not intended for U.S. and UK Media - American College of Cardiology 66th Annual Scientific Session (ACC.17):

EINSTEIN CHOICE Study with Bayer's Rivaroxaban Accepted for Late-Breaking Clinical Trial Presentation at ACC.17

Berlin, March 6, 2017 - Bayer AG and its development partner Janssen
Pharmaceuticals, Inc. announced today that results from the Phase III EINSTEIN
CHOICE study with the oral Factor Xa inhibitor rivaroxaban (Xarelto®) will be
presented as part of a Late-Breaking Clinical Trial Session on Saturday, March
18th as part of the upcoming American College of Cardiology 66th Annual
Scientific Session, which will take place in Washington, D.C., USA, from March
17 to 19.

The Phase III EINSTEIN CHOICE study investigated the efficacy and safety of two
doses of rivaroxaban (10 mg once daily and 20 mg once daily) versus aspirin
(100 mg once daily) for the extended treatment of patients with a venous
thromboembolism (VTE), who had previously completed 6 to 12 months of
anticoagulation therapy.(1) VTE includes pulmonary embolism and deep vein
thrombosis and is the third most common cause of cardiovascular death after
heart attack and stroke.(2) Existing Guidelines recommend anticoagulation
therapy for three months or longer for patients with an initial VTE.(3)
However, the risk for patients with unprovoked VTE or with ongoing risk factors
experiencing a second event is up to 10 percent in the first year if treatment
is stopped.(4) In clinical practice physicians need to carefully assess how
long to provide anticoagulation therapy for the individual patient following
the initial treatment phase and also which treatment regimen may best align
with the benefit-risk profile of the individual patient.

Additionally, results from the Phase II GEMINI ACS 1 study will be presented as
part of the same Late-Breaking Clinical Trial session at ACC.17. GEMINI ACS 1
assessed the safety of dual antithrombotic therapy of rivaroxaban 2.5 mg twice
daily in combination with clopidogrel or ticagrelor compared with dual
antiplatelet therapy of aspirin 100 mg once daily in combination with
clopidogrel or ticagrelor in patients with a recent acute coronary syndrome
(ACS).

Late-Breaking Clinical Trial Data on Rivaroxaban:
Late-Breaking Clinical Trial Session 404
Saturday 18 March, 08:00-08:25 EDT, Main Tent, Hall D
- EINSTEIN CHOICE: Rivaroxaban or Aspirin for Extended Treatment of Venous
Thromboembolism
- GEMINI ACS 1: A Randomized Trial Evaluating Clinically Significant Bleeding
With Low-Dose Rivaroxaban Versus Aspirin, in Addition to P2Y12 Inhibition, for
Patients After Acute Coronary Syndromes

Furthermore, new clinical and real-world insights on rivaroxaban will be
presented in oral and poster sessions at ACC.17:
- Rates of Oral Anticoagulant Use, While Improving Over Time, Remain Low Among
Hospitalized Patients with Atrial Fibrillation
o Poster Session 1110 - Fibrillatory Arrhythmias: Outcomes With Contemporary
Practice
o Friday 17 March, 10:00-10:45 EDT, Poster Hall, Hall C

- Incremental Risk of Ischemic Stroke Over Time in Newly Diagnosed Heart
Failure Patients without Atrial Fibrillation
o Poster Session 1123 - Making Progress in Understanding Heart Failure
o Friday 17 March, 10:00-10:45 EDT, Poster Hall, Hall C

- A Benefit-Risk Analysis of Recurrent Venous Thromboembolism in Patients Who
Continued Versus Discontinued Rivaroxaban Therapy After an Initial Six-Month
Therapy
o Oral Session 904 - Highlighted Original Research: Pulmonary Hypertension and
Venous Thromboembolic Disease and the Year in Review
o Saturday 18 March, 08:12-08:22 EDT, Room 147B

- Thrombolytic Therapy in Anticoagulated Patients: Case Series From Rivaroxaban
Versus Warfarin in Nonvalvular Atrial Fibrillation (ROCKET AF)
o Poster Session 1189 - Arrhythmias and Clinical EP: Anticoagulation Issues
o Saturday 18 March, 09:45-10:30 EDT, Poster Hall, Hall C

- Real-World Versus Randomized Trial Outcomes in Similar Populations of
Rivaroxaban-Treated Patients with Nonvalvular Atrial Fibrillation in ROCKET AF
and XANTUS
o Poster Session 1189 - Arrhythmias and Clinical EP: Anticoagulation Issues
o Saturday 18 March, 09:45-10:30 EDT, Poster Hall, Hall C

- Effectiveness and Safety of Apixaban and Rivaroxaban Versus Warfarin for the
Secondary Prevention of Stroke or Systemic Embolism Among Nonvalvular Atrial
Fibrillation Patients
o Poster Session 1190 - Atrial Fibrillation and VT: Specific Situations and
Newer Outcome Measures
o Saturday 18 March, 09:45-10:30 EDT, Poster Hall, Hall C

- Rivaroxaban Users Have Significantly Less Treatment Discontinuation Compared
with Users of Other Oral Anticoagulants in Non-Valvular Atrial Fibrillation
o Poster Session 1252 - Antithrombotic Therapy in Ischemic Heart Disease
o Saturday 18 March, 15:45-16:30 EDT, Poster Hall, Hall C

- Impact of Comorbid Coronary Artery Disease and Severe Peripheral Artery
Disease on Major Adverse Cardiovascular Events
o Poster Session 1287 - Interventional Cardiology: PCI in Complex Patients
o Sunday 19 March, 09:45-10:30 EDT, Poster Hall, Hall C

Separately, an investigator-initiated study, as well as independent studies
from the GARFIELD-AF (Global Anticoagulant Registry in the FIELD-Atrial
Fibrillation) and ORBIT-AF (Outcomes Registry for Better Informed Treatment of
Atrial Fibrillation) Registries will provide new real-world insights on
diagnosis and treatment patterns in patients with atrial fibrillation:
- Treatment And Outcomes of Patients With Nonvalvular Atrial Fibrillation
According to Guideline-Defined Anticoagulation Thresholds: Results From the
GARFIELD-AF Registry
o Poster Session 1110 - Fibrillatory Arrhythmias: Outcomes With Contemporary
Practice
o Friday 17 March, 10:00-10:45 EDT, Poster Hall, Hall C
?

- Designing Tailored Health Messaging To Enhance Patient-Centred Care in
Non-Valvular Atrial Fibrillation
o Poster Session 1130 - Innovations in Practice Management and Social Media
o Friday 17 March, 10:00-10:45 EDT, Poster Hall, Hall C

- Early Mortality in Patients With New Onset Atrial Fibrillation: Results From
the GARFIELD-AF Registry
o Moderated Poster Session 1134M - Atrial Fibrillation, Anticoagulation and
Novel Device Therapies
o Friday 17 March, 11:00-11:10 EDT, Arrhythmias and Clinical EP Moderated
Poster Theater, Poster Hall, Hall C

- Does Frailty Alter the Benefits of Oral Anticoagulation in Patients With
Atrial Fibrillation?
o Poster Session 1190 - Atrial Fibrillation and VT: Specific Situations and
Newer Outcome Measures
o Saturday 18 March, 09:45-10:30 EDT, Poster Hall, Hall C

- The Prescribing of Antiplatelet Therapy Only in Patients With Nonvalvular
Atrial Fibrillation: Results From the GARFIELD-AF Registry
o Moderated Poster Session 1223M - Stroke and AF: Thinking About the Heart

o Saturday 18 March, 12:45-12:55 EDT, Arrhythmias and Clinical EP Moderated
Poster Theater, Poster Hall, Hall C

- Nuisance Bleeding in Anticoagulated Patients With Atrial Fibrillation:
Insights From the Outcomes Registry for Better Informed Treatment of Atrial
Fibrillation (ORBIT-AF)
o Poster Session 1280 - Atrial Fibrillation and VT: Incorporating Novel Risks
Toward Decision Making
o Sunday 19 March, 09:45-10:30 EDT, Poster Hall, Hall C

?
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

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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Forward-looking statements

This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer 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.


1) Weitz JI, Bauersachs R, Beyer-Westendorf J, et al. Two doses of rivaroxaban
versus aspirin for prevention of recurrent venous thromboembolism. Thromb
Haemostasis 2015;114(3):645-50
2) Galioto N, Danley DL, Van Maanen RJ. Recurrent Venous Thromboembolism.
American Academy of Family Physicians 2011
3) Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease
CHEST Guideline and Expert Panel Report. CHEST 2017;149(2):315-52
4) Prandoni P, Noventa F, Ghirarduzzi A, et al. The risk of recurrent venous
thromboembolism after discontinuing anticoagulation in patients with acute
proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study
in 1,626 patients. Haematologica, The Hematology Journal 2007, 92(02), 199-205