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December 20, 2013

Approval for Additional Indication for Unresectable Pancreatic Cancer of 5-FU Injection 250mg and 1000mg

Tokyo, Japan, December 20, 2013 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has been obtained an approval for additional dosage and administration for unresectable pancreatic cancer of 5-FU Injection 250mg and 1000mg (generic name: Fluorouracil, "5-FU") from Japan's Ministry of Health, Labour and Welfare ("MHLW").

In accordance with the assessment of the "Review Committee on Unapproved Drugs and Indication with High Medical Needs*1" held on March 23, 2012, MHLW requested the development of additional indication and dosage of 5-FU for FOLFIRINOX therapy*2 on April 6, 2012, and as of May 31, 2013, Kyowa Hakko Kirin has submitted for additional indication for unresectable pancreatic cancer.
This approval is based on the results of a Phase II/III study conducted in France which is known as the ACCORD 11 study and the results of a Phase II study conducted by Yakult Honsha Co., Ltd. (Tokyo, President and COO: Takashige Negishi, "Yakult") in Japan regarding FOLFIRINOX regimen for patients of metastatic pancreatic cancer which had not been previously treated with chemotherapy.

Pancreatic cancer is one of cancers with less treatment options, and the incidence in 2008 has been estimated about 30,000 cases in Japan. Kyowa Hakko Kirin expects that the additional indication for administration and dosage will significantly contribute to the treatment of pancreatic cancer patients.

Kyowa Hakko Kirin has four strategic categories*3 including the oncology area, and is endeavoring to contribute to the treatment of cancer patients through the further development of anticancer agents.

*1: About Review Committee on Unapproved Drugs and Indication with High Medical Needs
The Committee was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in the United States and Europe but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "Application based on evidence in the public domain" and investigating the need for studies that should be additionally conducted.

FOLFIRINOX is a four drugs combination chemotherapy with 5-FU, leucovorin, irinotecan and oxaliplatin. This regimen is generally used for pancreatic cancer overseas and is already used as a standard therapy for pancreatic cancer in the U.S., Canada and the EU.
The ACCORD11 study showed that the median overall survival was 11.1 months, the median progression-free survival was 6.4 months and the objective response rate was 31.6% in patient with FOLFIRINOX regimen, which were significantly improved in comparison with patients with another standard chemotherapy, gemcitabine alone. As well, similar efficacy and tolerability to the ACCORD11 study were confirmed in the domestic Phase II study conducted by Yakult.

*3: 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 medium-term business plan.


Kyowa Hakko Kirin
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