Preventing Thromboses – One Tablet can save Lives

(f.l.t.r) Dr. med. Dagmar Kubitza, Dr. med. Frank Misselwitz, Dr. rer. nat. Elisabeth Perzborn

Dr. med. Frank Misselwitz (Spokesperson)
Dr. med. Dagmar Kubitza
Dr. rer. nat. Elisabeth Perzborn

Bayer Schering Pharma AG, Wuppertal

Blood clots are one of the most common causes of death in the western industrialized countries. Is there an effective and simple treatment to prevent this dangerous condition?

Frank Misselwitz, Dagmar Kubitza and Elisabeth Perzborn together with their teams have developed a new drug that has a very efficient working mechanism – and can be taken by patients in the form of a tablet. It is thus far superior to conventional thrombosis treatments. Frank Misselwitz is head of global clinical development for cardiovascular development at Bayer Schering Pharma and since 2002 has headed clinical development of the active-ingredient Rivaroxaban. Dagmar Kubitza is global clinical project manager for the pharmacological development of the substance. Elisabeth Perzborn as laboratory manager is responsible for planning, quality, and coordination of research in Rivaroxaban.

This active ingredient selectively and specifically intervenes in the biochemical processes during coagulation. This prevents this process from occurring uncontrollably – and prevents health-threatening blot clots from forming. The dangerous thing about blood clots is that they can travel through the body in the bloodstream and block the supply of blood to organs, such as the lungs – an embolism that is often fatal. The engine behind the formation of blood clots is the enzyme Factor Xa. It controls the synthesis of thrombin molecules. They convert fibrogen into fibrin – the “adhesive” in coagulation. By inhibiting the activity of the Factor Xa enzyme, Rivaroxaban reduces the risk of thrombosis. It is important that it does not stop blood from clotting entirely so that the body can still stop bleeding, such as after surgery.

In trials, Rivaroxaban proved to be not only superior in efficacy than previous standard treatments – with comparable safety profile; the active ingredient also simplifies its use: Patients can take Rivaroxaban in a single tablet form while conventional preparations have to be injected. Also, there is neither a need to monitor blood count during treatment nor to adjust the dose to age, weight, or sex of the patient.

In the late 1990’s, Bayer researchers began developing the drug. The preparation received its first approval eight years later – much faster than usual in the development of most new drugs. Rivaroxaban is approved under the brand name Xarelto® for use in the EU and other countries to prevent venous thromboembolism following elective hip or knee replacement surgeries. Additional approval of the drug for the prevention of venous thrombosis or stroke in patients with atrial fibrillation is to follow. More than 65,000 patients will take part in the trial program for Rivaroxaban. The potential is huge because millions of people are affected by thromboses every year. In the western world, more people die from the complications of blood clots than from breast cancer, prostate cancer, HIV/AIDS and traffic accidents combined. Bayer expects annual turnover potential of 2 billion Euros from the new anticoagulant drug.

The right to nominate outstanding achievements for the Deutscher Zukunftspreis is incumbent on leading German institutions in Science and Industry as well as foundations.

The project “Preventing Thrombosis – One Tablet can save Lives“ was nominated by acatech - Deutsche Akademie der Technikwissenschaften (The German Academy of Science and Engineering).

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