January 28, 2008
Asahi Kasei Pharma Corp.

Approval for sale of thrombomodulin in Japan

Asahi Kasei Pharma obtained approval on January 25, 2008, for the production and sale in Japan of recombinant thrombomodulin alpha, to be marketed as Recomodulin™, for the treatment of disseminated intravascular coagulation (DIC). Recomodulin™ is an intravenous anticoagulant featuring a new mechanism of action, suppressing the activity and production of thrombin, a blood coagulation factor.

While the potential for targeting thrombin as an approach to anticoagulation has long been known, natural thrombomodulin, which is a membrane protein expressed on the surface of vascular endothelial cells, has poor solubility in water, making it ill suited as a candidate for development as a pharmaceutical agent. Asahi Kasei Pharma applied genetic engineering to produce thrombomodulin alpha, reproducing the portion of the molecule which protrudes outside the cell membrane, including the active site, while adding solubility in water. Like natural thrombomodulin, thrombomodulin alpha binds specifically to thrombin, changing its substrate specificity to promote the activation of protein C, which suppresses the production of additional thrombin.

DIC is a condition in which the blood coagulation system becomes overactive, leading to blockage of capillaries, ischemia and other damage to vascular endothelial cells, and organ damage, together with diminished consumption of hemostatic factors and aggravation of secondary fibrinolysis, resulting in severe bleeding. DIC frequently occurs as a complication of malignant tumors and infections. It has been reported that once DIC develops, prognosis worsens considerably.

The date of initiation of sale of Recomodulin™ will be determined upon National Health Insurance price listing. Asahi Kasei Pharma will continue to gather and disseminate information related to the proper use of Recomodulin™, giving the highest priority to the safety of patients who are treated with it.


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