Press Release
62nd American College of Cardiology (ACC) Annual Scientific Session and Exposition:
New Data on Bayer’s Rivaroxaban Underscores Clinical Benefits of Arterial Clot Prevention in Two Major Cardiovascular Disorders
- Benefits of rivaroxaban in acute coronary syndrome (ACS) highlighted in new subanalyses to be presented from Phase III ATLAS ACS 2-TIMI 51 study
- Subanalysis from ROCKET AF Phase III trial to be presented, further exploring the protective benefits of rivaroxaban in stroke prevention in patients with AF
- Independently, Thrombosis Research Institute (TRI) and Duke Clinical Research Institute to present data from their Registries in patients with AF, which are supported through independent research grants from Bayer and Janssen respectively
Mar 1st, 2013 - Berlin, Germany – Bayer HealthCare announced today that new data
from the clinical development programme supporting its oral anticoagulant rivaroxaban
will be presented at the 62nd American College of Cardiology (ACC) Annual Scientific
Session and Exposition in San Francisco, CA, USA, March 9-11, 2013.
These data will provide new information and further insights regarding the potential
benefits of rivaroxaban in protecting patients at risk of dangerous blood clots in the arterial
thromboembolic setting, including more complete patient protection in the secondary
prevention of acute coronary syndrome (ACS) compared to standard treatment and
prevention of stroke in people with non-valvular atrial fibrillation (AF).
Notable data analyses to be presented at ACC.13 include*:
- Rivaroxaban Reduces Spontaneous and Large Myocardial Infarctions: Findings from the ATLAS ACS 2-TIMI 51 Trial
- Oral Presentation: 901-5; ACS: New Agents and Approaches
- Saturday, March 9, 2013; 8:30-8:45 am; West, Room 3001
- Rivaroxaban in the Setting of Continued Dual Antiplatelet Therapy: Findings from the ATLAS ACS 2-TIMI 51 Trial
- Oral Presentation: 901-6; ACS: New Agents and Approaches
- Saturday, March 9, 2013; 8:45-9:00 am; West, Room 3001
- Outcomes of Temporary Interruptions of Rivaroxaban or Warfarin in Patients with Atrial Fibrillation in the ROCKET AF Trial
- Oral Presentation: 914-5; Joint Session of the Heart Rhythm Society and the American College of Cardiology: Anticoagulation in Atrial Fibrillation - Management Questions with New Anticoagulants
- Sunday, March 10, 2013; 8:30-8:45 am; West, Room 3009
Full data from ATLAS ACS 2-TIMI 51 were presented at the American Heart Association
(AHA) Scientific Sessions meeting in 2011 and were simultaneously published in the New
England Journal of Medicine (NEJM). Rivaroxaban has been submitted for marketing
authorisation to reduce cardiovascular events in patients with ACS in more than 40
countries, including Europe and the U.S.
Full data from ROCKET AF were presented at the AHA Scientific Sessions meeting in
2010 and were published in the New England Journal of Medicine (NEJM) in September
2011. Once-daily rivaroxaban has received marketing authorisation for the prevention of
stroke and systemic embolism in patients with non-valvular AF in more than 80 countries
worldwide, including the EU, the U.S. and Japan.
GARFIELD and ORBIT-AF Registry Data to be Presented
Independently, the Thrombosis Research Institute (TRI) will present data from the
ongoing Global Anticoagulant Registry in the FIELD (GARFIELD), providing real-world
clinical insights into current anticoagulation therapies in AF management. The GARFIELD
Registry is an academic research initiative, led by the TRI and a multi-disciplinary
Steering Committee and supported by an unrestricted educational grant from Bayer
Pharma AG.
In addition, Duke Clinical Research Institute will present new data on the ORBIT-AF
Registry – a multicenter, prospective, outpatient, disease Registry of patients with incident
or prevalent AF that will analyze treatment patterns and outcomes in patients with AF in
the U.S. The Registry began in June 2010, led by Duke Clinical Research Institute, and is
a nationwide collaboration of healthcare providers, with a focus on the optimization of
outpatient management of patients with AF. ORBIT-AF is supported by an independent
research grant from Janssen Scientific Affairs, LLC.
- Atrial Fibrillation Treatment Paradox: Characteristics of and First-Year Events in Patients Not Treated with Vitamin-K Antagonists Compared to Treated Patients. The GARFIELD Registry
- Poster Presentation: 1237-49; Arrhythmias: AF/SVT VIII
- Sunday, March 10, 2013; 3:45-4:30 pm; Expo North
- Quality of Care, Symptoms, and 1 year Outcomes for Women vs. Men with Atrial Fibrillation: Primary Results from the ORBIT-AF Registry
- Late Breaker - Symposium Session 751. Featured Clinical Research II: General Cardiology
- Sunday, March 10, 2013; 5:48-6:00 pm; West, Room 2001
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 the 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.
sp (2013-0142E)
_________________________
*Abstracts will be available online on the ACC Scientific Session Website as of Thursday, March 7 at 8 a.m. PST
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.
- 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).
- 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.
- Thrombosis
- Formation of a clot inside a blood vessel.
- 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.
