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

Release of Flutiform , a combination drug for asthma treatment
TOKYO, JAPAN (November 19,2013) ― Kyorin Pharmaceutical Co., Ltd.(“Kyorin”) (Headoffice : Chiyoda-ku, Tokyo, President : Mitsutomo Miyashita), a wholly owned subsidiary ofKYORIN Holdings, Inc., announced the release of Flutiform®, a combination drug for asthmatreatment.
Flutiform® is a new fixed-dose combination of the active ingredients formoterol fumarate andfluticasone propionate in a pressurized metered-dose inhaler (pMDI), developed bySkyepharma (Head office : London, United Kingdom, CEO : Peter Grant). In overseas markets,
it is sold in 12 European countries to date under the brand name flutiform® (flutiformo® in Italy).
Kyorin Pharmaceutical Co., Ltd. (“Kyorin”) has undertaken clinical developments in Japan andobtained manufacture and sales approval in September 2013. This has led to the NHI pricelisting and launch of the product today.
At present, there are estimated to be nearly 5 million adult patients with bronchial asthma. It isreported that 60 to 80 percent of patients who come under treatment steps 2 to 4 of the “Asthma
Prevention and Management Guidelines 2012” have their symptoms insufficiently controlled,even if they are medicated for long-term control.*Flutiform® combines fluticasone and formoterol and uses a pressurized metered-dose inhaler(pMDI) that is easy to use and facilitates inhalation irrespective of the flow of inhalation. By
marketing this product, Kyorin hopes to contribute further to improved respiratory function in
bronchial asthma patients and better symptom control.
Flutiform® has the following characteristics :(1) Facilitating the simultaneous inhalation of fluticasone, a substance that exerts a potent
anti-inflammatory effect, and formoterol, a substance that rapidly dilates the bronchi.
(2) A bronchodilating effect is able to be achieved from immediately after inhalation, allowing forlong-lasting control of asthma symptoms.
(3) The use of an aerosol formulation (pMDI) allows the drug to be taken easily, irrespective of apatient’s inhalation ability.
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.
We expect sales of the drug in the initial year to reach nearly one billion yen.
Kyorin has launched a new website “Flutiform.jp”, for healthcare providers at www.flutiform.jp.

*Source : Kazuo.akiyama Allergology & Immunology, 19, 1120-1127 (2012)

(Product information)
Brand name: Flutiform® 50 Aerosol - 56 inhalations
Flutiform® 125 Aerosol - 56 inhalations
Active ingredient : fluticasone propionate (inhaled corticosteroid)
formoterol fumarate hydrate (a long-acting inhaled β2 agonist)Indication: Bronchial asthma (when a combination of an inhaled steroid and a long-acting Inhaled
β2 agonist is necessary)
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 thesymptoms, Flutiform® 125 Aerosol (125µg fluticasone propionate and 5µg formoterol
fumarate) can be used 2 times per day (2 to 4 inhalations per application).
NHI price: ¥2,735.20 per an inhaler (Flutiform® 50 Aerosol - 56 inhalations)¥2,193.10 per an inhaler(Flutiform® 125 Aerosol - 56 inhalations)
Date of Drug Price Listing: November 19, 2013
Date of initial marketing in Japan : November 19, 2013(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 the areasof inhalation, oral, topical and injectable delivery as well as generating income from thedevelopment of further products and technology licenses. The Group’s products aremarketed throughout the world by leading pharmaceutical companies.