April 28, 2017

Not intended for U.S. and UK Media

Rivaroxaban 10 mg Once Daily from Bayer Submitted to U.S. FDA as Additional Dose Option to Reduce the Risk of Recurrent Venous Thromboembolism

If approved, rivaroxaban 10 mg once daily will provide an additional treatment option alongside the already approved rivaroxaban 20 mg once-daily dose / Risk of recurrent thrombosis is up to 10% in the first year if anticoagulation therapy is stopped / Application to FDA supported by data from the EINSTEIN CHOICE study
Berlin, April 28, 2017 - Bayer AG and its development partner Janssen Research
& Development, LLC today announced the submission of a supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the
prescribing information for the oral Factor Xa inhibitor rivaroxaban (Xarelto®
), to include a 10 mg once-daily dose for reducing the risk of recurrent venous
thromboembolism (VTE) after at least six months of standard anticoagulation
therapy as an additional treatment option alongside the already approved
rivaroxaban 20 mg once-daily dose.

This application is supported by data from the Phase III EINSTEIN CHOICE study,
which showed that both 10 mg and 20 mg once-daily dosages of rivaroxaban
significantly reduced the risk of recurrent 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 treatment of pulmonary embolism
(PE) and / or symptomatic deep vein thrombosis (DVT). Patients with a
definitive need for continued therapeutic anticoagulation beyond the first 6 to
12 months were not included in the study. Both rivaroxaban dosages demonstrated
comparable and low rates of major bleeding (the principal safety outcome) on
the same level as aspirin therapy. Data from EINSTEIN CHOICE were recently
published in The New England Journal of Medicine and have been submitted to the
European Medicines Agency (EMA), with submissions to other Health Authorities
worldwide to follow during the first half of 2017.

VTE, which includes DVT, a blood clot in a deep vein (often in the legs), and
PE, a clot that travels to the lung, has a significant global impact as it is
the third most common cause of cardiovascular death worldwide, after heart
attack and stroke. The current treatment recommendation is anticoagulation
therapy for 3 months or longer, depending on the balance between the risk of
recurrent VTE and the risk of bleeding.

"Blood clots are related to 1 in 4 deaths worldwide. Given the potential for
serious and life-threatening events like stroke, pulmonary embolism, and deep
vein thrombosis among people at risk for clots, non-vitamin K antagonist oral
anticoagulants such as Xarelto are a critical treatment option. For patients
who have previously suffered a VTE, the risk of experiencing another event is
up to 10 percent during the first year if anticoagulant therapy is stopped, and
this figure rises to 20 percent within three years," said Dr Joerg Moeller,
Member of the Executive Committee of Bayer AG's Pharmaceutical Division and
Head of Development. "Once approved, the 10 mg once-daily dose of rivaroxaban
will offer an alternative treatment option in addition to the already approved
20 mg once-daily dose of rivaroxaban, which together will provide physicians
with the choice to select the extended treatment option that will best suit the
benefit-risk-assessment of the individual patient."

EINSTEIN CHOICE adds 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. With more than 28 million
patients prescribed Xarelto worldwide according to estimates based on IMS data,
real-world research continues to confirm that the benefit-risk profile remains
favorable and consistent with clinical trials for patients who have a high risk
of life-threatening blood clots that may cause strokes and other serious
medical complications. Specifically, results from XALIA, an observational
real-world study that enrolled 5,142 patients with DVT across 21 countries,
confirmed the well-established safety profile and efficacy seen with the
approved rivaroxaban dosing regimen of 20 mg once daily in EINSTEIN DVT, and
the real-world XAMOS study reaffirmed the benefit of rivaroxaban to prevent VTE
following hip or knee replacement, as first shown in the RECORD studies.
Additionally, the recent real-world evidence study REVISIT-US, a claims
analysis of nearly 23,000 patients with non-valvular atrial fibrillation,
supports the use of rivaroxaban for stroke prevention in patients with atrial
fibrillation. These data complement findings from the Phase III ROCKET AF study
as well as the non-interventional XANTUS study.

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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