flutiform phase III results in paediatric asthma

Skyepharma's partner Mundipharma announces results of pivotal phase III study for flutiform® in paediatric asthma

Data presented at ERS supports the potential of flutiform® for the treatment of paediatric asthma

LONDON, UK, 8 September, 2014 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, today announces that new data from a randomised, multicentre, pivotal phase III study of flutiform® for the treatment of paediatric asthma has been presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, (6-10 September 2014) by its licensing partner Mundipharma. The data shows the efficacy and tolerability of flutiform®, a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler, in children with asthma aged 5 to

The primary endpoint of this 12-week study was the change from predose FEV1 (forced expiratory volume in one second, a key measure of lung capacity) at baseline to 2-hour postdose FEV11 at the end of the study period. flutiform® (50/5µg 2 puffs twice per day) was superior to fluticasone propionate (50µg 2 puffs twice per day) and non-inferior compared with the commonly used combination fluticasone propionate/salmeterol (50/25µg 2 puffs twice per day) for the primary endpoint1. The study also showed flutiform® had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol1.

flutiform® is not licensed for paediatric use but it is already available in 18 countries across Europe for the treatment of asthma in adults as well as in adolescents aged 12 and above. Mundipharma International Corporation Limited is licensed by Skyepharma as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas.

The full text of the Mundipharma announcement is available at www.mundipharma.com/Press

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About flutiform® 

A novel combination, flutiform® combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting β2-agonist (LABA), in a single aerosol inhaler incorporating Skyepharma's proprietary SkyeDry™ technology. In Europe, flutiform® is indicated for the regular treatment of asthma in patients aged 12 years and over (50/5µg and 125/5µg strengths) and in adults (250/10µg strength) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting β2-agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.2

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 16 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 Mundipharma

The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and inflammatory conditions. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For further information please visit: www.mundipharma.com.

1 Ploszczuk, A et al., Efficacy and safety of fluticasone propionate/formoterol in paediatric patients with asthma. European Respiratory Society annual conference, Abstract. Munich, Germany 6 - 10 September 2014.

2 flutiform® Summary of Product Characteristics