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New Drug Application Approval for POTELIGEO® (Mogamulizumab) Injection in Japan, a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)



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March 30, 2012

New Drug Application Approval for
POTELIGEO® (Mogamulizumab) Injection in Japan,
a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)

Tokyo, Japan, March 30 2012 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has received approval for a new drug application (NDA) from the Ministry of Health, Labour and Welfare (MHLW) for POTELIGEO® (Mogamulizumab) Injection ("POTELIGEO®") that is a therapeutic antibody for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma (ATL).

POTELIGEO® is a humanized monoclonal antibody produced by applying POTELLIGENT®, a technology to produce antibodies with enhanced ADCC activity, which was developed exclusively by Kyowa Hakko Kirin. This product is the first antibody for which Kyowa Hakko Kirin has an NDA approved, and is also the world's first POTELLIGENT® antibody approved for marketing approval. POTELIGEO® binds to CCR4 that is expressed on the surface of ATL cells. POTELIGEO® was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the MHLW.

Kyowa Hakko Kirin is working to provide treatment for a wide range of diseases with an unmet medical need including orphan diseases such as ATL. Kyowa Hakko Kirin will strive to contribute to the improvement of patients' QOL through the development of therapeutic antibodies using its unique antibody technologies.


Overview of POTELIGEO®
Product Name POTELIGEO® Injection
Generic Name USAN, INN: Mogamulizumab
Indication Relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma
Dosage and Administration Once-weekly doses (eight administrations) of 1.0 mg/kg POTELIGEO® Injection.


About Adult T-cell leukemia-lymphoma (ATL)
HTLV-1 (retrovirus)-induced peripheral T-cell lymphoma. Currently, about 1150 people a year develop ATL in Japan. Generally, combination chemotherapy such as mLSG15 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 used based on the treatment of malignant lymphoma, but no effective treatment has been established.

About POTELLIGENT®
Kyowa Hakko Kirin's unique technology to produce antibodies with enhanced ADCC activity. This technique allows production of antibodies that reduces the amount of fucose in the carbohydrate structure of an antibody. Non-clinical animal studies have confirmed that antibodies produced by this technology killed the target cells much more efficiently than existing antibodies and exhibited stronger antitumor effects.

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 ADCC (antibody-dependent cellular cytotoxicity)
When an antibody binds to an antigen, effector cells such as macrophages and NK cells subsequently bind to the antibody. Antigen-bearing target cells are killed by these effector cells.


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