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April 26, 2011

Kyowa Hakko Kirin submitted New Drug Application in Japan for KW-0761,
a Therapeutic Antibody for Adult T-cell Leukemia-Lymphoma (ATL)

Tokyo, Japan, April 26 2011 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has submitted a new drug application (NDA) to the Ministry of Health, Labour and Welfare for KW-0761 under development for the treatment of adult T-cell leukemia-lymphoma (ATL).

KW-0761 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 submitted a NDA, and is also the world's first POTELLIGENT® antibody to be submitted for marketing approval. KW-0761 binds to CCR4 that is expressed on the surface of ATL cells. Clinical studies of KW-0761 in patients with relapsed CCR4-positive ATL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to submit an NDA. KW-0761 was also granted an orphan drug designation for the treatment of CCR4-positive ATL by the Ministry of Health, Labour and Welfare.

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 Phase II Clinical Study in Japan
Objective To evaluate the efficacy and safety of once-weekly doses (eight administrations) of 1.0 mg/kg KW-0761 in patients with relapsed CCR4-positive adult T-cell leukemia-lymphoma (ATL) after prior response to chemotherapy.
Target Sample Size 25 evaluable patients
Primary Endpoint overall response rate
Efficacy The efficacy of this product was evaluated in 26 patients.
Response rate: 50% (95%CI, 30-70%) 8 patients with complete response, 5 patients with partial response
Progression free survival (PFS) = 158 days (median value)
Safety The safety of this product was evaluated in 27 patients.
KW-0761 was found to be well tolerated at this dose level.

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 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.

Kyowa Hakko Kirin's unique technology to produce antibodies with enhanced ADCC activity. This technique allows production of antibodies that reduce 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.

Ongoing Clinical Studies related to KW-0761
Phase II
Multicenter, Randomized, Open-label, Parallel-group Study to
Compare mLSG15 + KW-0761 to mLSG15
Phase II
Study of KW-0761 in Subjects With
CCR4-positive Peripheral T/NK-cell Lymphoma
Phase I/II
Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects
With Peripheral T-cell Lymphoma


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