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World Congress of Cardiology 2006: New phase II studies demonstrate that Factor Xa inhibitor rivaroxaban is a promising oral anticoagulant for chronic use


Largest Phase II dose-finding programme reported in this setting to date / Oral dosing without the need for monitoring might set a new standard for anticoagulation therapy

Tuesday - September 5, 2006 - Leverkusen, Germany / Barcelona, Spain – Results of an extensive Phase II programme of rivaroxaban (BAY 59-7939), a novel oral anticoagulant (Factor Xa inhibitor), for the treatment of deep vein thrombosis (DVT) and its secondary prevention, were presented, today at the World Congress of Cardiology 2006 in Barcelona, Spain*. These important findings highlight the promising clinical potential of rivaroxaban for both acute and long-term anticoagulant care from hospital to home. Based on these research data the Phase III programme has been initiated.

“These data underlie our belief that once-daily rivaroxaban could lead to a change in the treatment paradigms in stroke prevention in atrial fibrillation and the treatment and secondary prevention of VTE areas where clinicians currently have no oral alternative to warfarin,” said Harry Büller MD PhD, of the Academic Medical Center, Amsterdam, principal investigator of EINSTEIN-DVT, and of the Phase III rivaroxaban programme for VTE treatment and secondary prevention.”

The Phase II dose-finding programme comprised two studies – ODIXa-DVT and EINSTEIN-DVT. The programmes enrolled a total of 1,156 patients with acute, symptomatic DVT and studied total daily doses of oral rivaroxaban in the range of 20 to 60 mg administered once daily in EINSTEIN-DVT and once and twice daily in ODIXa-DVT. The treatment plan was compared to a standard therapy of a parenterally administered heparin (e.g. enoxaparin) followed by an oral vitamin K antagonist (e.g. warfarin) for up to 3 months.

In ODIXa-DVT, rivaroxaban reduced clot size (thrombus burden – the primary efficacy measure) after 21 days and at three months with low rates of venous thromboembolism (VTE) recurrence. Similar results were seen in the EINSTEIN-DVT study.

Overall, the rate of recurrent DVT was low across all groups and similar across all rivaroxaban doses, and there was similar efficacy between any of the rivaroxaban doses tested and standard therapy. Key findings from both studies include:

• Recurrent DVT rates ranged from 0.9% to 1.0% for rivaroxaban vs. 0.9% with the comparator.
• Major bleeding rates ranged from 1.7% to 3.3% in the highest 60 mg dose vs. 0.0% with the comparator.

• Recurrent DVT rates ranged from 0.8% to 1.7% vs. 6.9% with the comparator.
• Major bleeding rates ranged from 0.0% to 1.5% with rivaroxaban and 1.5% with the comparator.
• Observed Symptomatic VTE events (VTE-related death, pulmonary embolism and recurrent DVT) were lower with all rivaroxaban doses tested than with the comparator (1.7–3.6% vs. 6.9%).
• There was no clinically significant difference with bleeding ranging from 2.2% to 6.0% with rivaroxaban vs. 8.8% with the comparator.

Low rates of bleeding were reported across the entire programme and there was no clinically relevant difference between any rivaroxaban dose tested and standard therapy. No dose arm studied was discontinued because of a lack of efficacy or safety concerns. In these 3-month studies for DVT treatment no signal for untoward effects of rivaroxaban on liver function was observed.

“I am very encouraged given the size and design of the programme,” said Robert Califf MD, director of the Duke Clinical Research Institute at the Duke University Medical Center, Durham, NC, USA and principal investigator for the Phase III clinical programme for stroke prevention in atrial fibrillation. “I look forward to working closely with Dr. Keith Fox from the University of Edinburgh Centre for Cardiovascular Science, Edinburgh University, Bayer and Ortho-McNeil to evaluate the clinical effectiveness of this exciting new drug. We are hopeful that this new mechanism will lead to safer and more predictable anticoagulation than warfarin, and this programme is designed to make a definitive comparison of this new approach compared with the old standard of care"

Rivaroxaban is already in Phase III clinical development for the primary prevention of VTE after major elective orthopaedic surgery. The RECORD (REgulation of Coagulation in major Orthopaedic surgery reducing the Risk of DVT and PE) study programme began in December 2005 and recruitment is on track and progressing well. First filing for market authorization in this indication is planned in late 2007.

About rivaroxaban (BAY 59-7939)
Rivaroxaban is a novel, oral, direct Factor Xa inhibitor that could potentially reduce the risk of life- threatening thromboembolic events. Factor Xa (the target enzyme) is a protease that acts at the pivotal point in the coagulation cascade (the process that leads to clot formation).

Published results show that rivaroxaban offers predictable anticoagulation across a wide range of parameters, which strongly suggests that routine coagulation monitoring will not be required. In addition, data also show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.

Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the health care and medical products industry based in Leverkusen/Germany. In 2005, the Bayer HealthCare subgroup generated sales amounting to some 9.4 billion Euro. Bayer HealthCare employed 33.800 people worldwide in 2005.

The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology, Oncology and Primary Care.

Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating diseases.

* Agnelli et al. Eur Heart J 2006; 27(suppl):abstract 87447, Büller. Eur Heart J 2006; 27 (suppl):abstract 89702

Forward-looking statements
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