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May 31, 2013

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

Tokyo, Japan, May 31, 2013---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has been filed an application to Japan's Ministry of Health, Labour and Welfare ("MHLW") seeking approval for additional dosage and administration for pancreatic cancer of 5-FU Injection 250mg and 1000mg (generic name: Fluorouracil, "5-FU").

In accordance with the assessment of the "Review Committee on Unapproved Drugs and Indication with High Medical Needs" held on March 23, 2012, MHLW requested the development of additional indication and dosage of 5-FU for FOLFIRINOX therapy (described below) on April 6, 2012.
This application is based on the results of a Phase II/III study conducted in France which is known as the ACCORD 11 study and 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 option, 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.

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.

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