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January 25, 2013

Results of Phase 3 Clinical Trials of KRN125 in Patients with Malignant Lymphoma and Breast Cancer in Japan

Tokyo, Japan, January 25, 2013 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today top-line results of two phase 3 trials of KRN125 (code name, generic name: pegfilgrastim) which is developed to decrease the risk of febrile neutropenia in chemotherapy- received patients. The studies were conducted with malignant lymphoma patients and breast cancer patients. Each study meets the primary endpoints.

KRN125 is a sustained-duration PEGylated form of a Granulocyte Colony-Stimulating Factor (G-CSF) product (GRAN®; generic name: filgrastim) which is used to treat chemotherapy-induced neutropenia. In cases of chemotherapy-induced neutropenia, treatment with GRAN® requires repeated daily doses over several days, whereas KRN125 shows efficacy with a single dose per cycle of chemotherapy. Therefore, KRN125 is expected to reduce the burden of hospital visits for outpatients who received chemotherapy treatment. By reducing the risk of infection resulting from neutropenia, KRN125 makes it possible to adhere to chemotherapy dosages and schedules, so it is expected to bring additional clinical benefits to the patients.

In order to confirm the safety and efficacy of KRN125, Kyowa Hakko Kirin conducted double-blind comparative studies as outlined below.

In the study of malignant lymphoma patients, the efficacy of KRN125 was compared with filgrastim at 50 μg/m2 subcutaneously given for consecutive days by assessing the primary endpoint of the duration of severe neutropenia defined as neutrophil count of less than 500/μL. As a result, non-inferiority of KRN125 to filgrastim was confirmed. No clinically significant difference in the safety between the treatments was observed.

In the study of breast cancer patients, incidence of febrile neutropenia, the primary endpoint, was assessed in patients receiving KRN125 or placebo. As a result, the incidence of febrile neutropenia was significantly lower in KRN125-treatment group compared to placebo. No clinically significant difference in the safety between KRN125 and placebo was observed.

Based on the above findings, Kyowa Hakko Kirin is planning to file a marketing approval application for KRN125 in 2013 in Japan.

Kyowa Hakko Kirin is a pharmaceutical company contributing to human health and well-being of people around the world through innovative drug discovery, mainly in the core therapeutic areas of oncology, nephrology, immunology and allergy.

About febrile neutropenia arising as a complication of chemotherapy
A condition in which decrease in cancer patients' neutrophils (a type of white blood cells which form part of the body's defense system) by chemotherapies develops lasting fever and leads to suspicion of infection.

About Granulocyte Colony-Stimulating Factor (G-CSF) products
G-CSF products are proteins produced using gene recombination. The G-CSF selectively stimulates the production of neutrophils and also further enhances the neutrophil function. Based on this mechanism, the G-CSF is used to accelerate recovery of chemotherapy-induced neutropenia, and it reduces various risks associated with neutropenia.

About PEGylation
PEGylation is a chemical binding of polyethylene glycol to filgrastim.


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