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June 29, 2011

Kyowa Hakko Kirin announces a Commencement of Phase 3 Clinical Study for KW-3357 in Japan

Tokyo, Japan, June 29, 2011 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has commenced the phase 3 clinical study of KW-3357 in Japan for disseminated intravascular coagulation (DIC) accompanied by a decrease in antithrombin (AT).

KW-3357 is the world's first fucose-deficient recombinant AT preparation, which is the same type as the native form of AT. KW-3357 was made by the application of our unique POTELLIGENT® technology. 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 risk of infection, which is a concern in blood preparations, will be avoided.

The results of the phase 1 clinical study in Japan demonstrated the safety of KW-3357 and confirmed the dose that exhibits activities equivalent to human plasma-derived AT preparations. In response to the results of the studies, we have come to commence the phase 3 clinical studies with the indication of DIC accompanied by a decrease in AT.

Kyowa Hakko Kirin aims to contribute to human health and well being worldwide through innovative drug discovery and global commercialization, driven by state-of-art biotechnology.

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 59,000. The indications for the native form of AT preparation currently on the market are "thrombophilia due to congenital AT deficiency" and "disseminated intravascular coagulation accompanied by a decrease in AT."

About Disseminated Intravascular Coagulation (DIC)
Disseminated Intravascular Coagulation (DIC) may be observed as a disorder that accompanies cancer,, as well as serious infection such as septicemia, leukemia, malignant lymphoma, and placental abruption. 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, the body reacts to dissolve these clots, while platelets and coagulant factors are spent for creating clots. This results in decreased platelets and coagulant factors, as well as bleeding.

About Fucose
Fucose is one type of sugar that forms a sugar chain.
Antithrombin is a protein with 3 or 4 sugar chains; however, the native form of antithrombin does not contain fucose.

Ongoing Clinical Studies of KW-3357
Phase 3
An Open-label Study of KW-3357
Phase 3
A Clinical Study of KW-3357 in Patients With DIC
Phase 3
A Phase 3 Clinical Study of KW-3357 in Patients With DIC

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