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December 13, 2012

Kyowa Hakko Kirin Initiates Pivotal Phase 3 Trial of Mogamulizumab (KW-0761) in Patients with Cutaneous T-Cell Lymphoma in the United States

Tokyo, Japan, December 13, 2012 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the initiation of a phase 3 clinical trial in the United States to evaluate the efficacy and safety of mogamulizumab (generic name / code name: KW-0761) in patients with relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL). Mogamulizumab has been granted orphan-drug designation for the treatment of CTCL by the U.S. Food and Drug Administration and the European Commission.

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including CTCL cells. Engineered by Kyowa Hakko Kirin's unique 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 Adult T-Cell Leukemia-Lymphoma (ATL), and is being investigated world-wide in a number of clinical studies for other potential indications.

Kyowa Hakko Kirin is committed to developing treatments for a wide range of diseases with unmet medical need, including orphan diseases such as CTCL. 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 3 Trial of Mogamulizumab in Patients with CTCL
ClinicalTrials.gov Identifier NCT01728805
Condition Relapsed/refractory CTCL
Trial Design Multi-center, open-label, randomized trial of mogamulizumab or vorinostat
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
Vorinostat:
400 mg orally daily until progression
Trial Location USA and other potential countries (excluding Japan)
Primary Objective Progression free survival

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a rare, low grade type of non-Hodgkin's lymphoma. CTCL is one of the most common forms of T-cell lymphoma. The two most common types of CTCL are mycosis fungoides (MF) and Sezary syndrome (SS). MF does not look the same in all patients and may present as skin patches, plaques, and tumors. SS in an advanced form of MF and includes the presence of malignant lymphocytes in the blood.

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. For more information, please visit www.POTELLIGENT.com

About CC chemokine receptor 4 (CCR4)
CCR4 is one of the chemokine receptors involved in leukocyte migration, selectively expressed in type 2 helper T (Th2) cells and regulatory T (Treg) cells. CCR4 is also shown to be over-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.

About Adult T-cell leukemia-lymphoma (ATL)
ATL is a rare and aggressive form of T-cell non-Hodgkin's lymphoma that is caused by human T-lymphotropic virus-1 infection. This virus selectively infects T-cells. The incidence of ATL is highest in geographic areas where HTLV-1 infection is endemic, including areas of southern Japan, South and Central America, West Africa, the southeastern US, and the Caribbean basin. ATL is a rare disease with no established standard of care.

About Vorinostat
Vorinostat (ZOLINZA®) is a histone deacetylase inhibitor and was approved by the U.S. Food and Drug Administration for the treatment of CTCL on October 6, 2006.




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