Company name: KYORIN Holdings, Inc.
Representative: Masahiro Yamashita
Representative Director, President(Securities Code: 4569, TSE 1st Sec.)

Approval received for Flutiform®, a combination drug for asthma treatment
TOKYO,JAPAN (September 20,2013) ― Kyorin Pharmaceutical Co., Ltd.(“Kyorin”) (Headoffice: Chiyoda-ku, Tokyo, President: Mitsutomo Miyashita), a wholly owned subsidiary of KYORIN
Holdings, Inc., announced today that Flutiform®, a combination drug for asthma treatment hasreceived approval from the Ministry of Health, Labor and Welfare(“MHLW”).
Flutiform® is a new fixed-dose combination of the active ingredients formoterol fumarate andfluticasone propionate in a propellant-driven metered dose inhaler, developed by Skyepharma(Head office: London, United Kingdom, CEO：Peter Grant).

In overseas markets, it has to date been sold in 12 European countries under the brand nameflutiform® (flutiformo® in Italy). In Japan, Kyorin signed a licensing agreement with
Skyepharma (exclusive rights in Japan for clinical development, sales and marketing) on April
22, 2008, after which the clinical development of Flutiform® in Japan moved ahead. On
September 25, 2012 Kyorin filed a new drug application for Flutiform® at the MHLW.
Currently, in the “Asthma Prevention and Management Guidelines 2012” of the JapaneseSociety of Allergology, the use of inhaled steroids and long-acting β2-agonists as a single agent
in combination with other drugs or as a combination drug is recommended for treatment steps
2 to 4.
Flutiform® contains fluticasone, which exerts a potent anti-inflammatory effect, and formoterol,
which has a rapid and long-lasting bronchodilating effect. Further, it is contained in apropellant-driven metered dose inhaler that is easy to use, and it is expected to be a drug thatmeets the needs of patients and healthcare practitioners, such as improvement of respiratory
function in patients with bronchial asthma and long-term control of asthma symptoms.

Kyorin has added Flutiform® to the line-up of its priority area of respiratory products, and isdetermined to contribute to better patient care by continuously providing up-to-date information.
The timing of the launch and sales projection will be announced at an appropriate time after
the NHI price is listed.
(Product information)
Brand name: Flutiform® 50 Aerosol - 56 inhalations / 120 inhalations
Flutiform® 125 Aerosol - 56 inhalations / 120 inhalations
Active ingredient : fluticasone propionate (inhaled corticosteroid)
formoterol fumarate hydrate (a long-acting inhaled β2agonist)Indication: Bronchial asthma (when a combination of an inhaled steroid and a long-acting
Inhaled β2agonist is necessary)
Originated by: Skyepharma PLC
Dosage and administration:
Adults should use Flutiform® 50 Aerosol (50µg fluticasone propionate and 5µg
formoterol fumarate) 2 times per day (2 inhalations per application). Depending on
the symptoms, Flutiform® 125 Aerosol (125µg fluticasone propionate and 5µgformoterol fumarate) can be used 2 times per day (2 to 4 inhalations perapplication).

(For Reference)
About Skyepharma PLC
Established in: March 1910 (renamed to present company name in January 1996)
CEO: Peter Grant
Location: 46-48 Grosvenor Gardens, London SW1W 0EB, United Kingdom
Revenue: £49.9 million (2012)
Number of employees: 85 (2012 average)
Features: Skyepharma, a London-based pharmaceutical company, is an expert drug delivery
company which combines proven scientific expertise with validated proprietary drugdelivery technologies to develop innovative oral and inhalation pharmaceuticalproducts. The Group receives revenues from fourteen approved products in theareas of inhalation, oral, topical and injectable delivery as well as generating income
from the development of further products and technology licenses. The Group’s
products are marketed throughout the world by leading pharmaceutical companies.