Skyepharma PLC's Partner Kyorin Launches Flutiform® In Japan

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LONDON, UK, 19 November, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, today announces that flutiform® has been launched in Japan following agreement on pricing reimbursement.

flutiform® is being marketed in Japan by Skyepharma’s licensing partner, Kyorin Pharmaceutical Co, Ltd. (“Kyorin”), as “flutiform® 50 Aerosol” (56 inhalations) and “flutiform® 125 Aerosol” (56 inhalations) for the treatment of patients aged 16 years and over with bronchial asthma. A milestone of several million U.S. Dollars was received from Kyorin following regulatory approval in September 2013 and Skyepharma is entitled to high-mid single digit royalties on net sales.

flutiform® is the first product on the Japanese market to combine the fast acting LABA (Long-Acting Beta Agonist) formoterol and the ICS (Inhaled Corticosteroid), fluticasone. It has already been approved in 21 countries in Europe and in Australia, Hong Kong, Israel and South Korea. The development for Japan involved close collaboration between Kyorin and Skyepharma, including the development of the 56 inhalations versions of flutiform®.

Kyorin estimates that the market in Japan for asthma and Chronic Obstructive Pulmonary Disease (COPD) is currently worth U.S. $2.4 to $2.8 billion, with asthma accounting for more than half of the total. Kyorin also estimates that there are some 3.3 to 3.5 million adult asthma patients in Japan.

Kyorin is responsible for the development, marketing and distribution of flutiform® in Japan, the world’s second- largest pharmaceutical market. Kyorin is a major player in the Japanese asthma market. With its co-marketing partner MSD, Kyorin promotes the country’s biggest-selling asthma product, Merck & Co’s blockbuster montelukast, which is sold in Japan under the trade name Kipres® (Singulair® by MSD). Sales of Kipres® totalled Yen 39.6 billion (c. U.S. $400 million) in the year ended 31 March 2013. Kyorin also sells Mucodyne® (carbocisteine), a mucoregulant extensively prescribed for acute and chronic respiratory diseases with annual sales of Yen 19.1 billion (c. U.S. $190 million). Through its distribution of Kipres® and Mucodyne®, Kyorin has built a large and experienced sales force of approximately 750 representatives that have well-established connections with respiratory specialists and prescribing physicians across Japan.

In line with standard practice, National Health Insurance (“NHI”) pricing reimbursement is only available for the 56 inhalations versions of the product for the first 12 months after launch. The 120 inhalations versions of flutiform®, which are already approved for marketing, will therefore be launched in 12 months’ time. Agreed NHI pricing for the 56 inhalations versions of flutiform® are comparable with equivalent combination inhaled asthma products.

In a press release today, Kyorin announced that it is targeting sales (measured at NHI prices) of flutiform® during its fiscal year ending 31 March 2014 following launch of approximately Yen 1 billion (c. U.S. $10 million).

Peter Grant, Chief Executive Officer of Skyepharma, commented:

“The launch of flutiform by Kyorin brings a new inhaled treatment option to people suffering from asthma in Japan. Kyorin has already established a strong and highly successful position in the Japanese respiratory market and has built excellent relationships with key opinion leaders and clinicians in the field. We are proud of our close and long-term partnership with Kyorin and look forward to flutiform’s success in this important market.”

Mitsutomo Miyashita, President of Kyorin Pharmaceutical Co., Ltd. (“Kyorin”) (head office: Chiyoda-ku, Tokyo), commented:

“Kyorin is delighted to launch flutiform, enabling us to provide a new treatment option to bronchial asthma patients. By enhancing our respiratory product portfolio with this new combination, Kyorin will continue to contribute to the improved treatment and quality of life of more asthma patients in Japan.

“Kyorin is pursuing its Franchise Customer (FC) strategy, which focuses sales and marketing activities on its priority fields of respiratory medicine, otolaryngology and urology. By concentrating on flutiform’s early penetration of the market, Kyorin will strive to further reinforce its operational base in Japan.”

For further information please contact:

Skyepharma PLC

Peter Grant, Chief Executive Officer +44 207 881 0524

FTI Consulting

Julia Phillips/Stephanie Cuthbert/Natalie Garland-Collins +44 207 831 3113

N+1 Singer

Shaun Dobson/Jennifer Wyllie +44 207 496 3000

About flutiform®

A novel combination, flutiform® combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting ß2-agonist (LABA) in a single aerosol inhaler incorporating Skyepharma’s proprietary SkyeDry™ technology. In Japan, flutiform® is indicated for the regular treatment of bronchial asthma in patients aged 16 years and over (50/5µg and 125/5µg strengths) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting ß2-agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.

Clinical evidence behind flutiform®

The Skyepharma Group commenced development of flutiform® in 2004 and carried out a substantial part of the development of the product including all the pre-clinical and chemistry, manufacturing and control work as well as having a significant role in the clinical trial process. In 2008 the Group appointed Kyorin as the development partner and authorised distributor of flutiform® for Japan.

Skyepharma worked with Kyorin to develop a 56 inhalations version of flutiform® to meet the Japanese regulatory requirement that only two weeks of treatment may be prescribed in the first 12 months from launch. This was an extensive development programme, largely funded by Kyorin, involving adaptations to the presentation, including the device.

The Japanese New Drug Application submission included data used in the European Marketing Authorisation Application, which recently gained approval in 21 countries in Europe, together with the results from three additional Phase I/II studies and two additional Phase III clinical studies conducted by Kyorin. The Phase III studies were conducted with an additional patient population of c. 700 (of whom 472 received flutiform®) and both studies (A301 and A302) met their primary endpoints.

Study A301 included patients suffering from asthma. They were treated in an eight week single-blind, randomised, multiple centre, two arm parallel group study, to assess the efficacy and safety of KRP-108. The two treatment arms were: (1) KRP-108; and (2) Flutide 50 (fluticasone) pMDI (pressurised metered dose inhaler). The changes in the mean values of morning PEF (Peak Expiratory Flow) was the primary endpoint measured. The top line analysis confirms that KRP-108 achieved consistently higher results when compared with Flutide® 50 and demonstrated that KRP-108 was well tolerated in the study patients.

Study A302 included patients suffering from mild to severe asthma. They were treated over 52 weeks in an open-label, multiple centre, three arm study to assess the safety and efficacy of KRP-108. The results are consistent with the large safety database already accumulated on flutiform®. Skyepharma is responsible for the supply of flutiform® to Kyorin.

About Skyepharma

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 14 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.skyepharma.com

About Kyorin

The Kyorin Group which is headquartered in Japan focuses on respiratory medicine, otolaryngology, and urology. Key products include Kipres®, for treating bronchial asthma and allergic rhinitis; Mucodyne®, a mucoregulant; Pentasa®, for treating ulcerative colitis and Crohn's disease; and Uritos®, for treating overactive bladder. For more information see www.kyorin-pharm.co.jp/.

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