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September 26, 2014

Approval for Sustained-Duration G-CSF Product G-Lasta® in Japan

Tokyo, Japan, September 26, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has received approval for sustained-duration G-CSF product G-Lasta® subcutaneous injection 3.6mg (G-Lasta®) [generic name: pegfilgrastim (genetical recombination)] by the Ministry of Health, Labour and Welfare (MHLW).

G-Lasta® is a sustained duration form of Granulocyte Colony-Stimulating Factor (G-CSF) product, which is produced by PEGylation of filgrastim, for treatment of chemotherapy-induced 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 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 chemotherapy-induced febrile neutropenia
Chemotherapy-induced febrile neutropenia is a condition with an abnormally low level of infection-fighting white blood cells (neutrophils) and continuous fever, and its patient is strongly suspected to be suffered from infection.

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

G-Lasta® Product Summary

Product name G-Lasta® subcutaneous injection 3.6mg
Nonproprietary name pegfilgrastim (genetical recombination)
Indication Febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy
Packaging G-Lasta® subcutaneous injection 3.6mg:1 syringe
Approval date September 26, 2014


Kyowa Hakko Kirin
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