Press Release

Bayer Initiates Xarelto® (Rivaroxaban) Study in Patients with Non- Valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention with Stent Placement

Mar 8th, 2013 - Berlin, Germany – Bayer HealthCare announced today the initiation of the PIONEER AF-PCI study, a Phase IIIb clinical study of its oral anticoagulant Xarelto (rivaroxaban) to investigate how best to treat patients with non-valvular atrial fibrillation (AF) who undergo percutaneous coronary intervention (PCI) with stent placement.

The PIONEER AF-PCI study will enroll approximately 2,100 patients worldwide. The trial will assess the safety of two rivaroxaban treatment strategies and a dose-adjusted vitamin K antagonist (VKA) treatment strategy. Patients will be treated for 12 months.

“There are limited data available on how best to treat those patients with atrial fibrillation
who require anticoagulant therapy for stroke prevention and also have a coronary stent
implanted requiring dual antiplatelet therapy,” said C. Michael Gibson, M.S., M.D.,
Chairman of the PERFUSE Study Group, Harvard Medical School, and the Principal
Investigator of the PIONEER AF-PCI study. “This study will help to address a clinically
important question and provide physicians with information needed to make treatment
decisions for this high-risk patient population.”

“We heard the excitement from physicians when Xarelto was approved for use in patients
with non-valvular atrial fibrillation and we also listened to the questions they asked us
about what to do for patients with overlapping risk factors,” said Dr. Kemal Malik, Member
of the Bayer HealthCare Executive Committee and Head of Global Development. “The
PIONEER AF-PCI study is part of our ongoing commitment to improve patient outcomes
across a broad range of venous and arterial thromboembolic conditions.”

The PIONEER AF-PCI trial is part of the global clinical development program for rivaroxaban, which will - by the time of its completion – have involved more than 100,000 patients worldwide.

About PIONEER AF-PCI

The PIONEER AF-PCI study (an open-label, randomized, controlled, multicentre study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in patients with atrial fibrillation who undergo percutaneous coronary intervention) will include approximately 2,100 patients worldwide. Patients with documented AF following PCI will be enrolled into the study. The primary endpoint is the composite of TIMI major bleeding, minor bleeding and bleeding requiring medical attention (known collectively as clinically significant bleeding). In the study, patients will be randomized into three arms:

  • Rivaroxaban 15 mg once daily and a P2Y12 inhibitor (such as clopidogrel 75 mg daily)
  • Rivaroxaban 2.5 mg twice daily, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg daily
  • Dose-adjusted VKA, a P2Y12 inhibitor (such as clopidogrel 75 mg daily) and ASA 75-100 mg daily

About Venous and Arterial Thromboembolism (VAT)

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous and Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.

VAT is responsible for a number of serious and life threatening conditions:

  • Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal
  • Arterial Thromboembolism (ATE) occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina

VAT is responsible for significant morbidity and mortality, and requires active or
preventative treatment to avoid potentially serious or fatal patient outcomes.

To learn more about VAT, please visit www.VATspace.com.

About Xarelto (Rivaroxaban)

Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under
the brand name Xarelto. To date, Xarelto is approved for six distinct uses in he venous arterial thromboembolic (VAT) space:

  • 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 deep vein thrombosis (DVT) in adults
  • The treatment of pulmonary embolism (PE) in adults
  • The prevention of recurrent DVT and PE in adults
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery

Whilst licences may differ from country to country, across all indications Xarelto is
approved in more than 120 countries.

Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).

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 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

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health
care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with
annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative
companies in the healthcare and medical products industry and is based in Leverkusen,
Germany. The company combines the global activities of the Animal Health, Consumer
Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to
discover, develop, manufacture and market products that will improve human and animal
health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information at
www.healthcare.bayer.com.

Our online press service is just a click away: press.healthcare.bayer.com.

Contact:
Astrid Kranz, Tel. +49 30 468-12057
E-Mail: astrid.kranz@bayer.com

Stephanie Prate, Tel. +49 30 468-196053
E-Mail: stephanie.prate@bayer.com

Find more information at www.bayerpharma.com.
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Forward-Looking Statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group 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 our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.


Atrial fibrillation
A heart rhythm disorder where chambers in the upper heart (atria) beat more rapidly than those in the lower section of the heart. Blood is not pumped out of the upper chambers completely during beating, and may pool and form a clot. A stroke results if a section of clot dislodges from the upper chambers and becomes lodged in the brain.
Vitamin K antagonist
An anticoagulant that inhibits multiple steps in the blood clotting process. Administered orally, the dose varies by patient, and regular monitoring and dose adjustment is required. Vitamin K antagonists have interactions with food and other drugs. Due to the many limitations of this drug, many patients are actually not treated and many of those who are treated are outside of the required target INR range, which can be the cause for increased bleeding or a greater risk of stroke.
Thrombosis
Formation of a clot inside a blood vessel.
Acute coronary syndrome
An umbrella term used to cover any group of clinical symptoms compatible with an acute heart attack. The subtypes of acute coronary syndrome include unstable angina (in which the heart muscle is not damaged), and two forms of heart attack in which the heart muscle is damaged. These latter types are named according to the appearance of the electrocardiogram as non-ST segment elevation myocardial infarction (NSTEMI) and ST segment elevation myocardial infarction (STEMI).
Venous thromboembolism
A disease process beginning with a blood clot occurring within the venous system, including deep vein thrombosis and pulmonary embolism.
Deep vein thrombosis
A blood clot in a deep vein, usually resulting from damage to the vein or blood flow slowing down or stopping. Usually DVTs are found in the leg, but can also be in the arm. Distal DVTs are found in deep veins of the calf, and are the most common type of DVT. Proximal DVTs are found in the legs above the calf muscle up to the waist.
Pulmonary embolism
A potentially fatal condition caused by a blood clot blocking a vessel in the lung: usually the clot originates from a DVT in the legs. PE can result in permanent lung damage.

Contact

Stephanie Prate

Global Pharma Product PR Corporate Communications &
Public Affairs

Address:

Bayer Pharma AG
Germany-13353 Berlin

Telephone: +49 30 468 196053
Telefax: +49 30 468 996053

E-Mail Stephanie Prate

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