LONDON, UK, 19 September, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, today announces that Mundipharma Research Limited (“Mundipharma”), which is responsible for the on-going development of flutiform? in Europe and most territories outside the Americas and Japan, has commenced an international clinical trial of flutiform? for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”).
The study is a randomised, double-blind study comparing flutiform? 250/10 µg and flutiform? 125/5 µg with formoterol 12 µg in subjects with COPD. The primary endpoint of the study is to compare the annualised rate of moderate and severe COPD exacerbations during a 52-week treatment period. The aim of the study is to demonstrate the superiority of the efficacy of flutiform? over formoterol in a pressurised metered dose inhaler (“pMDI”). The planned number of subjects in the trials is 1,530. The cost of these COPD studies will be borne by Mundipharma.
flutiform? has already been approved for the treatment of bronchial asthma in 21 European countries, as well as in Israel, Australia and Hong Kong. It is currently marketed for the treatment of bronchial asthma in 12 European countries. It is not currently indicated for COPD.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
“Following the successful launch of flutiform in Europe for the treatment of bronchial asthma, we welcome Mundipharma’s decision to initiate studies to look at the potential of flutiform for the treatment of COPD, which is a major cause of mortality in Europe and around the world. We look forward to the results of the COPD trials and to the continued roll-out of flutiform by Mundipharma, which is already providing many asthma patients with a new and effective treatment option.”
Prof. Dr. Karen Reimer, Managing Director, Mundipharma Research Limited, commented:
“flutiform has already been approved as a maintenance therapy for bronchial asthma in adults and adolescents. We’re delighted with the progress that we’ve made to date with this product and we believe that it also has the potential to be an important new treatment option for patients suffering from COPD.”
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 2006 the Group appointed Mundipharma as the development partner and authorised distributor of flutiform? for Europe and most other territories outside Japan and the Americas.
flutiform? combines, for the first time in Europe, the fast acting LABA (Long-Acting Beta Agonist) formoterol, and the most widely prescribed ICS (Inhaled Corticosteroid), fluticasone.
Since the decision by the European Commission in favour of granting marketing authorisations for flutiform? in 2012, flutiform? has been approved in all 21 countries of the decentralised procedure and launched in 12 countries: Germany, the UK, Italy, Belgium, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway, Slovakia and Sweden. For the remaining 9 countries, including France, further launches are anticipated during 2013/14 once pricing and reimbursement processes are concluded.
For further information please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer +44 207 881 0524
FTI Consulting
Julia Phillips/Susan Stuart/Natalie Garland-Collins +44 207 831 3113
N+1 Singer
Shaun Dobson/Jennifer Wyllie +44 207 496 3000
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 Mundipharma
The Mundipharma network of independent associated companies have become leaders in pain management, and are building a growing presence in the oncology, rheumatoid arthritis and respiratory markets. Through innovation and acquisition, the Mundipharma mission is to deliver cutting-edge treatment solutions that meet the pressing needs of healthcare professionals and patients. For more information: www.mundipharma.com.
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