SKP.L Regulatory News (SKP)

flutiform® approved in Japan

Approval triggers milestone of several million U.S. Dollars

LONDON, UK, 20 September, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, announces that the Japanese Ministry of Health, Labour and Welfare ("MHLW"), has granted official administrative marketing authorisation to Skyepharma's licencing partner, Kyorin Pharmaceutical Co, Ltd. ("Kyorin") for flutiform®, which will be marketed as "flutiform® 50 Aerosol" (56 inhalations or 120 inhalations), and "flutiform® 125 Aerosol" (56 or 120 inhalations) for the treatment of adult patients with bronchial asthma in Japan. This approval, in one of the world's largest pharmaceutical markets, follows the successful launch of flutiform® in Europe last year.

Following this approval, a milestone of several million U.S. Dollars is now payable by Kyorin to Skyepharma and the Group will also receive high-mid single digit royalties on net sales in Japan.

Kyorin is responsible for the development, marketing and distribution of flutiform® in Japan and intends to launch the product as soon as possible, once pricing and reimbursement has been finalised. Kyorin is well established in the Japanese respiratory market, where it has marketed (under licence from Merck & Co.) the leading leukotriene receptor antagonist/bronchial asthma treatment medicine, Kipres® (montelukast sodium). Kipres® is marketed by Merck & Co. in the U.S. and other countries under the brand name Singulair®.

flutiform® will be the first product on the Japanese market to combine the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the ICS (Inhaled Corticosteroid), fluticasone.

flutiform® is indicated in Japan for the regular treatment of asthma in patients aged 16 years and over when concomitant use of an inhaled corticosteroid and long-acting beta-agonist is required.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"Following the successful launch of flutiform in Europe, the approval in Japan is another significant development for Skyepharma and a further endorsement of our ability to develop innovative and complex respiratory products. flutiform represents a new treatment approach for both patients and clinicians in one of the world's largest pharmaceutical markets. We look forward to the launch of flutiform by Kyorin, providing asthma patients in Japan with a new and effective treatment option." 

Additional information

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 inhalation 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 a number of 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.

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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/