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April 26, 2011

Kyowa Medex Submitted New Drug Application for
In Vitro Diagnostic Reagent to Detect CCR4 Proteins in Japan

Tokyo, Japan, April 26 2011 --- Kyowa Medex Co., Ltd. ("Kyowa Medex") announced today that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for two in vitro diagnostic (IVD) reagents under development for companion diagnostics of KW-0761.

These products are IVD reagents as principles of immunohistochemistry (IHC) and flow cytometry (FCM). These products are used for aiding the diagnosis for therapy of adult T-cell leukemia-lymphoma (ATL), a target disease for KW-0761 whose new drug application (NDA) was submitted today by Kyowa Hakko Kirin Co., Ltd.

KW-0761 exerts an effect against CCR4. These diagnostic products can determine the presence of CCR4 expressed by ATL cells before treatment of KW-0761. Diagnostic reagent as principle of IHC was used tissue samples such as lymph node or skin of ATL patients. Diagnostic reagent based on FCM can be applied to blood sample of ATL patients. The combination of diagnosis and treatment has potential to provide better treatment option for patients in today's increasingly tailoring treatments.

Kyowa Medex is working to support treatment for a wide range of diseases and contribute to the improvement of patients' QOL through the development of IVD reagents that meet the current needs in addition to biochemistry reagents and immunoassay reagents and instruments, which are its current major products.

About companion diagnostics
An in vitro diagnostic reagent used for personalized medicine. Identification of genes and biomarkers can allow physicians to provide highly effective treatment for each patient with fewer adverse drug reactions, and also allow patients to choose the best treatment and therapeutic agents. Companion diagnostics are already used for the treatment of specific cancers.

About adult T-cell leukemia-lymphoma (ATL)
HTLV1 (retrovirus)-induced peripheral T-cell lymphoma. Currently, about 2000 people are suffering from ATL in Japan. Generally, combination chemotherapy such as mLSG15 therapy is used, but no curative treatment has been established for ATL, except transplantation, which is actively being studied at present. For recurrent/relapsed ATL, different types of chemotherapies are performed based on the treatment of malignant lymphoma, but no effective treatment has been established.

About CCR4 (chemokine [C-C motif] receptor 4)
CCR4 is one of chemokine receptors involved in leukocyte migration. It is known that in normal cells, CCR4 is selectively expressed in type 2 helper T (Th2) cells that produce cytokines such as IL-4 and IL-5 (CD4-positive). It is also known that CCR4 is highly expressed in certain hematological malignancies.

About Kyowa Medex
Kyowa Medex Co., Ltd. (ISO 9001 certified, Tokyo, Japan) is a wholly owned subsidiary of Kyowa Hakko Kirin founded in 1981 taking over the parent company's operation related to diagnostic reagent. Kyowa Medex has been focusing on developing, manufacturing and marketing of clinical diagnostic reagents (immunological and biochemical), and has 8 sales bases all over Japan. Based upon its accumulated biotechnological expertise, Kyowa Medex developed, for example, an enzymatic assay reagent for a HDL cholesterol direct measurement, which is the first reagent launched in the world. Also Kyowa Medex has progressively diversified its operations through such initiatives as its in-house development of a fully automated clinical chemical analyzer and the import of superior diagnostic products from overseas.

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