Conclusion of Co-promotion agreement on
Recomodulin™ anticoagulant intravenous infusion 12800

September 30, 2013
Asahi Kasei Pharma Corp.
Pfizer Japan Inc.

Asahi Kasei Pharma Corp. (Head office: Chiyoda-ku, Tokyo, Japan; President: Toshio Asano; hereinafter “Asahi Kasei Pharma”) and Pfizer Japan Inc. (Shibuya-ku, Tokyo, Japan; President: Ichiro Umeda; hereinafter “Pfizer”) hereby announce that they have concluded a co-promotion agreement in Japan for Recomodulin™ anticoagulant intravenous infusion 12800 (recombinant thrombomodulin alpha) which is manufactured and sold by Asahi Kasei Pharma.

Under the terms of the agreement, Asahi Kasei Pharma and Pfizer are scheduled to begin co-promotion of the product on November 1, 2013. In Pfizer the promotion activities for Recomodulin™ will be performed by the Infectious Disease Division. Asahi Kasei Pharma will continue manufacturing and product distribution, and sales will be recorded by Asahi Kasei Pharma.

Developed by Asahi Kasei Pharma and sold in Japan since 2008, Recomodulin™ is a thrombomodulin agent for the treatment of disseminated intravascular coagulation (DIC). It improves the symptoms of DIC with a new mechanism of controlling blood coagulation. DIC is known as a serious condition that often accompanies infections. Asahi Kasei Pharma is now conducting a global Phase III clinical trial for this agent in patients with severe sepsis and coagulopathy.

Through close cooperation between Asahi Kasei Pharma, with its experience and track record in the field of DIC therapy, and Pfizer, with its strengths in promotional activity in the field of infectious disease, the co-promotion will serve to maximize the value of Recomodulin™ and further contribute to the treatment of DIC.

About Recomodulin™

Recomodulin™ is a thrombomodulin agent manufactured using genetic recombination technology. It acts as an anticoagulant by suppressing the activity and production of thrombin, a blood coagulation factor.

About DIC

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.

About coagulopathy

Coagulopathy is a systemic state of excessive coagulation. In patients with sepsis, endotoxins can hyperactivate the coagulation system by exciting the inflammatory cytokine network, resulting in coagulopathy.

About sepsis

Sepsis is a medical condition that is characterized by a whole-body inflammatory state caused by an infection. Without treatment, sepsis will almost certainly lead to death due to shock, DIC, multiple organ dysfunction, etc. Even with treatment, prognoses have not generally been favorable, as sepsis tends to occur in patients whose physical condition is already severely compromised.


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