Press Release
Astellas Submits Supplemental New Drug Application
for Approval of Additional Indication of Selective
SGLT2 Inhibitor Ipragliflozin L-Proline for Patientswith Type 1 Diabetes Mellitus in JapanTokyo and City, January 11, 2018 - Astellas Pharma Inc. (TSE: 4503, President andCEO: Yoshihiko Hatanaka, “Astellas” ) and Kotobuki Pharmaceutical Co., Ltd.
(President and CEO; Hiroshi Tomiyama, “Kotobuki”) today announced that Astellassubmitted an application for the additional indication of the selective SGLT2 inhibitor
Ipragliflozin L-Proline (generic name, brand name: “Suglat ® Tablets, development
code: ASP1941, “Ipragliflozin”) for the treatment of type 1 diabetes mellitus in Japan.
Type 1 diabetes mellitus is a disease with insulin deficiency that occurs when the βcells in the pancreas, which secrete insulin, are destroyed through immune system. It
has been estimated that around 10 million people in Japan are very likely to havediabetes1. It was estimated that type 1 diabetes mellitus account for around 6% ofpatients with diabetes2.
Ipragliflozin is a selective SGLT2 (Sodium-Glucose Co-transporter 2) inhibitordiscovered through a research collaboration and is being jointly developed withKotobuki. SGLTs are membrane proteins exist on the cell surface and transfer
glucose into cells. SGLT2 is one subtype of SGLTs that plays a key role in thereuptake of glucose in the the proximal tubule of the kidneys. By selectively inhibiting
SGLT2, Ipragliflozin suppresses the reuptake of glucose and reduces blood glucose
levels.
Ipragliflozin received marketing approval for the indication of type 2 diabetes underthe brand name Suglat® Tablets in January 2014 and has been on the market sinceApril 2014.
Through the application for the indication, Astellas expects to provide a newtreatment option for patients with type 1 diabetes mellitus whose glycemic control isinadequate and enhance its contribution to the treatment of diabetes.
The submission of the application for an approval has no impact on Astellas’
consolidated financial forecasts for the fiscal year 2017 ending March 31, 2018.
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(1) Overview of “National Health and Nutrition Survey” Findings in 2016, Ministry of Health, Labour andWalfare.
(2) Japan Diabetes Complication and its Prevention (JDCP) Prospective Study 2015,
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people
around the world through the provision of innovative and reliable pharmaceutical products. We focus on
Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas whileadvancing new therapeutic areas and discovery research leveraging new technologies/modalities. We
are also creating new value by combining internal capabilities and external expertise in themedical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science
into value for patients. For more information, please visit our website at https://www.astellas.com/en.

About Kotobuki
Kotobuki Pharmaceutical Co., Ltd., based in Nagano, Japan, is a company dedicates its efforts toresearch and development of innovative drugs and to provide generic drugs. We put a priority on
Diabetes/Nephrology, Gastroenterology, Dyslipidemia, Oncology and Immunology as focused
therapeutic areas in our research. We continuously pursue high level of creativity in drug discovery,
quality of products and morality for contributing to higher level of quality of life and healthy life
expectancy of patients.
For more information, please visit our website at https://ssl.kotobuki-pharm.co.jp/en/

Cautionary Notes (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs
and other statements that are not historical facts are forward-looking statements about the future
performance of Astellas. These statements are based on management’s current assumptions andbeliefs in light of the information currently available to it and involve known and unknown risks anduncertainties. A number of factors could cause actual results to differ materially from those discussed in
the forward-looking statements. Such factors include, but are not limited to: (i) changes in general
economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency
exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market
existing and new products effectively, (v) the inability of Astellas to continue to effectively research anddevelop products accepted by customers in highly competitive markets, and (vi) infringements ofAstellas ’ intellectual property rights by third parties. Information about pharmaceutical products(including products currently in development) which is included in this press release is not intended toconstitute an advertisement or medical advice.
###Contacts for inquiries or additional information:
Astellas Pharma Inc.
Corporate Communications
TEL: +81-3-3244-3201 FAX: +81-3-5201-7473

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Kotobuki Pharmaceutical Co., Ltd.
Corporate Communications
TEL: +81-268-82-2211 FAX: +81-268-82-2215

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