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August 1, 2014

Kyowa Hakko Kirin Submits Application for Approval in Japan for KW-3357

Tokyo, Japan, August 1, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for recombinant human antithrombin (AT) preparation (code name: KW-3357) which is developed for thrombophilia due to congenital AT III deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT III.

Kyowa Hakko Kirin conducted the phase 3 studies described below in order to confirm the safety and efficacy of KW-3357 in Japan and filed a marketing approval application for the preparation based on the results of those phase 3 studies.

1) The open-label, parallel-group, randomized study of KW-3357 versus plasma-derived AT (pAT) in patient with DIC associated with infections indicated that KW-3357 showed the similar results as pAT in recovery rate from DIC on Day 6 as the primary endpoint, other endpoints for efficacy and the safety profile.

2) Effectiveness and safety of KW-3357 were confirmed in the open-label studies of KW-3357 with heparins/heparinoids in patients with DIC by The Japanese Association for Acute Medicine (JAAM) diagnostic criteria or The Japanese Ministry of Health and Welfare (JMHW) diagnostic criteria.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Antithrombin (AT)
Antithrombin (AT) is a component of blood that inhibits blood coagulation. It is a single-chain glycoprotein with a molecular weight of approximately 60,000. The indications for the native form of AT preparation currently on the market are "thrombophilia due to congenital AT III deficiency" and disseminated intravascular coagulation accompanied by a decrease in AT III.

About KW-3357
KW-3357 is a preparation containing a recombinant AT that has the identical amino acid sequence of human plasma derived AT and the similar sugar chain profile. AT inhibits coagulant action by forming a complex with the protease involved in blood coagulation. Since KW-3357 is a recombinant AT preparation, it is expected that the infection risk resulting from human blood will be avoided.

About Congenital Antithrombin Deficiency (CAD)
CAD is a genetic disorder characterized by iterative thrombosis. Continued AT deficiency results in a decrease in anticoagulant activity, and minor factors that normally would not lead to thrombus formation can result in thrombosis.

About Disseminated Intravascular Coagulation (DIC)
Disseminated Intravascular Coagulation may be observed as a disorder that accompanies cancer, serious infections such as septicemia, leukemia, malignant lymphoma, placental abruption and so forth. When a person has DIC, blood clots are formed more easily in the capillaries around the body and results in clots that obstruct blood circulation in organs such as the kidneys, liver, and brain, which then causes disorders in the affected organs. If many clots form, platelets and coagulant factors are spent not to form new clots for hemostasis. The reactions to dissolve clots get to be enhanced for the multiple clots at the same time. These things result in bleeding.


Kyowa Hakko Kirin
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