Submission of New Drug Application in Japan for KRP-108/flutiform®

LONDON, UK - SkyePharma PLC (LSE: SKP) today announces that its development and marketing partner Kyorin Pharmaceutical Co., Ltd. ("Kyorin") has submitted a New Drug Application ("NDA") with the Japanese authorities for KRP-108 (flutiform®) for the treatment of bronchial asthma (in patients who require combination therapy with inhaled corticosteroids plus inhaled, long-acting beta-2-agonists).

The NDA 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 the two additional Phase III clinical studies for the Japanese development programme for KRP-108/flutiform® in which 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).  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®.

Peter Grant, Chief Executive Officer of SkyePharma, commented:

"We are pleased that the NDA for KRP-108/ flutiform has been filed by Kyorin in Japan so quickly after the initial approvals have been obtained in Europe.  With over 8 million asthma patients in Japan we believe that KRP-108/flutiform, when approved, will provide doctors and patients with an important additional asthma treatment option that combines two of the most effective asthma medications available."

On approval of KRP-108/flutiform® the Group is entitled to a milestone worth several million U.S. dollars and will then receive a high-mid single digit percentage royalty on net sales of KRP-108/flutiform® for the later of (i) ten years from the date of first commercial sale in Japan and (ii) the expiration of the Group's patents in the territory.

It is estimated 1 that 6.7% of the total population, approximately 8.5 million people, have been diagnosed with asthma in Japan.  According to IMS 2 the preventative asthma/COPD market size in Japan in 2011 was estimated at U.S.$2.4 billion (£1.5 billion), with a four-year compound annual growth rate of 11.5%.  The asthma segments, where KRP-108/flutiform® would compete once approved and launched, is typically over half this total market, which comprise anti-leukotrienes, ICS, ICS/LABAs, LAMAs and PDE-4 inhibitors.

1.   Global Burden for Asthma report for the Global Initiative for Asthma (GINA), 2004.

2.   Source: IMS data for 2011.  Preventative market defined as: anti-leukotrienes, ICS, ICS/LABAs, LABAs, LAMAs and PDE-4 inhibitors (where available).  Definition does not include hospital formulations e.g. IV or nebulised forms, or sustained-release theophylline.  Where sales data is limited (e.g. retail only, or none available) appropriate scaling approaches are used.  LAMA = Long-acting Muscarinic Antagonist.  PDE-4 = Phosphodiesterase 4 inhibitor.

For further information please contact:

SkyePharma PLC
Peter Grant, Chief Executive Officer
+44 207 881 0524
FTI Consulting
Jonathan Birt/Julia Phillips/Susan Stuart
+44 207 831 3113

About SkyePharma

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products.  The Group receives revenues from thirteen approved products in the areas 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.  For more information, visit 

About Kyorin

The Kyorin Group has headquarters in Japan and 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