Approval for Additional Indication for PTCL and CTCL of Mogamulizumab

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Tokyo, Japan, March 17 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO® Injection) from Japan's Ministry of Health, Labour and Welfare ("MHLW").

Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including PTCL and 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 also granted orphan drug designations for the treatment of PTCL and CTCL in March 2013 by the MHLW.

Mogamulizumab was launched in Japan with the brand name "POTELIGIO® Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.

Kyowa Hakko Kirin has four strategic categories including the oncology area, and is endeavoring to contribute to the treatment of cancer patients through the further development of anticancer agents.


About CCR4 (CC chemokine receptor 4)
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 Peripheral T-Cell Lymphoma (PTCL)
Non-Hodgkin lymphomas account for the majority of malignant lymphoma cases and can be broadly divided into disease of B-cell origin and T/natural killer (NK)-cell origin. Disease of T/NK-cell origin can be classified according to the main lesion site into nodal, extranodal, cutaneous, and leukemic disease. PTCL is a general term describing nodal and extranodal disease of T/NK-cell origin.

About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a rare, low grade type of non-Hodgkin's 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 is 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 antibody-dependent cellular cytotoxicity (ADCC)
ADCC is one of the body's immune responses, 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.

Orphan drug designation
A drug must meet the following three conditions in order to be granted an orphan drug designation in Japan.

1) The number of patients with severe disease who may use the drug is less than 50,000 in Japan.

2) There are high medical needs for the drug (There is no appropriate alternative drug/treatment, or high efficacy or safety is expected compared with existing products).

3) There is high possibility of development (There should be a theoretical rationale for the use of the drug for the target disease, and the development plan should be appropriate). For designated orphan drugs, measures to support the research and development activities are taken (The orphan drug and orphan medical device research and development promotion program by the MHLW).

About adult T-cell leukemia-lymphoma (ATL)
ATL is a peripheral T-cell malignancy and the retrovirus HTLV-1 is thought to be involved in its onset. Estimates show that around 1,150 new cases occur every year in Japan. ATL is generally treated with combination chemotherapy, such as mLSG15, but there are currently no therapeutic methods with the potential of providing a cure for ATL, although researchers are actively looking into other methods than transplantation. For relapsed/refractory cases, various chemotherapy regimens based on malignant lymphoma therapies are currently used, but an effective treatment method has yet to be established.

About four categories
These are the following four disease areas: Nephrology, Oncology, Immunology&Allergy and Central Nervous System, as presented in Kyowa Hakko Kirin's FY 2013-2015 mid-term business plan.

News Source : Approval for Additional Indication for PTCL and CTCL of Mogamulizumab

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