flutiform recommended for approval in Japan

flutiform® recommended for approval in Japan

LONDON, UK, 31 July, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, announces that the Pharmaceutical Affairs and Food Sanitation Council's Second Committee on Drugs, of the Japanese Ministry of Health, Labour and Welfare ("MHLW"), has recommended approval of flutiform® for bronchial asthma treatment in Japan.

flutiform® is licensed to Kyorin Pharmaceutical Co, Ltd. ("Kyorin") for Japan. A milestone of several million U.S. Dollars is payable to Skyepharma on approval of flutiform® in Japan. Skyepharma will also receive high-mid single digit royalties on net sales. 

The new drug application for flutiform® will now be considered by the MHLW's regulatory committee (Bunka-Kai) for the official administrative marketing authorisation. In parallel, the MHLW is also considering pricing for the National Health Insurance drug price list, which must be agreed prior to any launch. flutiform® combines for the first time in Japan the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the ICS (Inhaled Corticosteroid), fluticasone.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"The recommendation for approval of flutiform in Japan follows encouraging feedback from Skyepharma's partners on progress made in the initial launch markets in Europe. We look forward to the continued roll-out of flutiform in other countries, providing asthma patients with a new and effective treatment option."

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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 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 www.kyorin-pharma.co.jp.