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November 27, 2014

Launch of Sustained-Duration G-CSF Product G-Lasta® in Japan

Tokyo, Japan, November 27, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that sustained-duration G-CSF product G-Lasta® subcutaneous injection 3.6mg (G-Lasta®) [generic name: pegfilgrastim (genetical recombination)] will be launched in Japan on November 28, 2014.

G-Lasta® is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for decreasing the incidence of chemotherapy-associated febrile neutropenia. While filgrastim requires repeated daily doses over several days, G-Lasta® shows comparable efficacy with a single dose per chemotherapy cycle. G-Lasta® is therefore expected to reduce the burden of drug administration and to decrease frequent hospital visits of outpatients undergoing chemotherapy. Also, prophylactic administration of G-Lasta® prior to febrile neutropenia is expected to reduce risks of infection, which results in clinical benefits such as improving the compliance with doses and schedules of chemotherapy.

Pegfilgrastim, originally generated by Amgen, Inc., was licensed from Kirin-Amgen Inc., to Kyowa Hakko Kirin. It has already been approved in 107 countries and regions around the world.

Kyowa Hakko Kirin is focusing on the oncology area, along with three other focused areas as our category-based strategy. Kyowa Hakko Kirin is expecting to contribute to the treatment of cancer patients through the approval of drugs in accordance with medical needs.

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

About PEGylation
PEGylation is a chemical modification of protein bound by polyethylene glycol. PEGylation enables protein to suppress degradation and to reduce clearance in human body, resulting in improving retention of the protein in the blood stream and prolonging the duration of its activities.

About febrile neutropenia
Myelosuppressive chemotherapy causes low neutrophil count, i.e. neutropenia, which can raise risk of infections. Neutropenia with fever, known as febrile neutropenia, can be a sign of a serious infection and the patient needs to be given appropriate treatments.

About Kirin-Amgen Inc.
A joint venture between Kirin Holdings and Amgen.


Kyowa Hakko Kirin
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