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August 23, 2012

Kyowa Hakko Kirin Initiates Pivotal Phase 2 Trial of Mogamulizumab (KW-0761) in Patients with Adult T-cell Leukemia-Lymphoma in the United States and Europe

Tokyo, Japan, August 23, 2012 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") today announced the initiation of a phase 2 clinical trial in the United States and Europe for evaluating mogamulizumab (generic name / code name: KW-0761) in patients with previously treated Adult T-cell Leukemia-Lymphoma ("ATL"). Mogamulizumab has been granted orphan-drug designation for the treatment of ATL by both the U.S. Food and Drug Administration and the European Commission.

Mogamulizumab is a humanized monoclonal antibody directed against CC chemokine receptor 4 ("CCR4"), which is over-expressed on various malignant T cells, including ATL cells. Engineered by Kyowa Hakko Kirin's POTELLIGENT® Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC).
Mogamulizumab was approved in Japan in March 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL, making it Kyowa Hakko Kirin's first antibody launched, as well as the world's first POTELLIGENT® antibody granted marketing approval. The drug is being marketed under the trade name of POTELIGEO® Injection.

Kyowa Hakko Kirin is committed to developing treatments for a wide range of diseases with unmet medical need, including orphan diseases such as ATL. Kyowa Hakko Kirin strives to contribute to the improvement of patients' quality of life (QOL) through the development of innovative therapeutics.

Outline of the Phase 2 Trial of Mogamulizumab in Patients with ATL

ClinicalTrials.gov Identifier NCT01626664
Condition Previously treated ATL
Trial Design Multi-center, open-label, randomized trial of mogamulizumab or Investigator's choice of treatment
Mogamulizumab:
1.0 mg/kg weekly x 4 in cycle 1, then every other week in subsequent cycles until progression, in 28-day treatment cycles
Investigator's choice of treatment:
Pralatrexate (30 mg/m2 weekly for 3 weeks until progression), gemcitabine plus oxaliplatin (gemcitabine 1000 mg/m2, oxaliplatin 100 mg/m2 every 2 weeks until progression), DHAP (dexamethasone 40 mg on day 1-4, cisplatin 100 mg/m2, cytarabine 2000 mg/m2 every 4 weeks until progression), each in 28-day treatment cycles
Sample Size 70 subjects
Trial Location USA, UK, France, Belgium, and other potential countries
Primary Objective Overall response rate (ORR)

About Adult T-cell Leukemia-Lymphoma (ATL)
ATL is a disease entity within the category of mature T-cell and NK-cell neoplasms, according to the classification by the World Health Organization. It is a very aggressive T-lymphocytic malignancy caused by human T-lymphotropic virus-1 (HTLV-1; retrovirus) infection. The incidence of ATL is highest in geographic areas where HTLV-1 infection is endemic, including areas of southern Japan and the Caribbean basin. In nonendemic regions such as North America and Europe, HTLV-1 infection is mainly found in immigrants from endemic areas, their offspring or sexual contacts. Treatment regimens for ATL have not been standardized, especially in the relapsed/refractory setting, representing a large unmet medical need in this patient population.

About POTELLIGENT®
POTELLIGENT® is Kyowa Hakko Kirin's unique technology for the production of antibodies with enhanced ADCC activity. This technique enables production of antibodies with a reduced amount of fucose in their carbohydrate structure. Non-clinical studies have demonstrated that antibodies produced using this technology killed target cells more efficiently than conventional antibodies and exhibited stronger antitumor effects.

About CC chemokine receptor 4 (CCR4 )
CCR4 is one of the chemokine receptors involved in leukocyte migration. 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). CCR4 is also highly expressed in certain hematological malignancies.

About antibody-dependent cellular cytotoxicity (ADCC)
ADCC is a body's immune reaction, initiated by binding of an antibody to its antigen on target cells, followed by lysis of the antibody-bound target cells by effector cells such as natural killer cells. ADCC is known to be one of the modes of action of therapeutic antibodies.



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