Bayer Committed to Prevention of Arterial Thrombosis:
Bayer Completes Enrollment into Major Phase III Study with Rivaroxaban (ROCKET AF)
- ROCKET AF study compares rivaroxaban to warfarin in the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation
- Bayer Schering Pharma supports Thrombosis Research Institute’s launch of GARFIELD – a global patient Registry to evaluate ‘real life’ outcomes in the prevention of stroke in patients with Atrial Fib
- Fast Track designation for rivaroxaban development program in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome recognizes high unmet medical need.
Aug 30th, 2009 - Barcelona – Bayer Schering Pharma has completed patient enrollment into the Phase III ROCKET AF study (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation). The ROCKET AF study is assessing the efficacy and safety of rivaroxaban (Xarelto®) 20 mg once-daily, a novel oral, direct Factor Xa inhibitor, compared to the current standard of care, warfarin, a vitamin K antagonist (VKA) dose-adjusted, for the prevention of stroke and non-CNS systemic embolism in patients with Atrial Fibrillation (AF).
“We are most encouraged by the excellent progress of the ROCKET AF study in Atrial Fibrillation and look forward to the study results in 2010,” said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Chief Medical Officer.
ROCKET AF is a prospective, randomized, double-blind, double-dummy study including 14,269 patients from more than 1,100 centers across 45 countries, worldwide. The study design and rationale will be presented at the European Society of Cardiology (ESC) Congress in Barcelona1.
GARFIELD Patient Registry
GARFIELD (Global Anticoagulant Registry in the FIELD), a Registry of 50,000 newly diagnosed patients with AF, was also announced at the ESC Congress today by the Thrombosis Research Institute (TRI) – an independent charitable research foundation dedicated to improving care in patients with cardiovascular disease. The Registry will follow patients prospectively for up to six years to assess the global burden of AF and its launch is being supported by a research grant from Bayer Schering Pharma.
“The largest study of its kind to date, and involving unselected patients in randomly identified sites in up to 50 countries around the world, GARFIELD is unique in focusing on identifying real life outcomes. This includes the limitations of current interventions to prevent stroke, and how new opportunities in both AF management and the emerging novel anticoagulant agents might be used to improve clinical outcomes and reduce the potential burden of thromboembolic stroke for patients, healthcare systems and society more generally,” said Professor Ajay Kakkar Director of the Thrombosis Research Institute and Professor of Surgical Sciences at Queen Mary University of London.
“Our substantial research grant to the Thrombosis Research Institute for the initiation of GARFIELD supports an exceptional project and one which we hope will generate important new knowledge of great benefit to AF sufferers and those responsible for their care, helping to improve clinical outcome,” added Kemal Malik.
Unmet Medical Need in SPAF
AF affects over six million people in Europe2. It causes the two upper chambers of the heart (the atria) to quiver instead of beating effectively; resulting in blood not being completely pumped out, which in turn causes pooling and can lead to clotting in the atria. If a blood clot leaves the atria, it can become lodged in an artery in the brain causing the patient to suffer from an ischemic stroke3. Approximately one in five ischemic strokes are due to AF4.
It is particularly important to prevent such events as AF-related strokes are more severe, cause greater disability and have a worse prognosis than strokes in patients without AF4. New treatments for SPAF are required as existing options, such as VKAs, have a narrow therapeutic window and optimal dosing is difficult to achieve. Therefore, patients taking warfarin must be monitored frequently to ensure they receive the correct dose.
Fast Track Designation for Rivaroxaban in Acute Coronary Syndrome
The US Food and Drug Administration (FDA) grant of Fast Track designation for the rivaroxaban development program (ATLAS ACS TIMI 51) in the secondary prevention of cardiovascular events in patients with Acute Coronary Syndrome (ACS) recognizes the high unmet medical need. The trial is investigating the efficacy and safety of rivaroxaban in up to 16,000 patients. Data are expected in 2011.
Rivaroxaban was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Rivaroxaban is approved in the European Union for the prevention of VTE in adult patients undergoing elective hip or knee replacement surgery. Rivaroxaban is marketed under the brand name Xarelto. Additional approvals have been granted in other countries, including Australia, Canada, China, Mexico and Singapore. To date, Xarelto has been launched in more than 40 countries around the world by Bayer HealthCare.
The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today. More than 65,000 patients are expected to be enrolled into the rivaroxaban clinical development program, which will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders, including VTE treatment, stroke prevention in patients with atrial fibrillation, secondary prevention of acute coronary syndrome, and VTE prevention in hospitalized, medically ill patients.
To learn more about thrombosis, please visit www.thrombosisadviser.com
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, 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, Bayer Schering Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
Find more information at www.bayerscheringpharma.de.
Astrid Kranz, Tel.: +49 30-468-12057
Alexander Siedler, Tel.: +49 30-468-12727
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Patel, M. Rationale and design of the ROCKET AF study: comparison of rivaroxaban with warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation. (Poster 305) The European Society of Cardiology; 08.30-12.30, September 01 2009; Barcelona, Spain
2 Kannel WB, Benjamin EJ. Status of the epidemiology of atrial fibrillation. Med Clin North Am 2008;92:17-40
3 NHS choices. Atrial fibrillation: introduction. 2007 www.nhs.uk/Conditions/Atrial-fibrillation. Accessed March 2009
4 Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke 2005;36:1115-19
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.
- The ability of a drug to produce the desired effect.
- Factor Xa
- Pivotal component of blood clotting cascade. Stimulates the production of thrombin, the enzyme in the coagulation cascade that promotes the formation of blood clots.
- 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.