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Mundipharma Commences COPD Trial

CAMBRIDGE, England, September 19, 2013 /PRNewswire/ --

Mundipharma Research Limited (Mundipharma) announced today a major milestone in the development programme of flutiform® (fluticasone propionate / formoterol fumarate) for the treatment of Chronic Obstructive Pulmonary Disease (COPD) with the commencement of a key clinical trial. COPD is a life-threatening lung disease that interferes with normal breathing, estimated to affect at least 64 million people worldwide[1].   The first patient in the trial is expected to start treatment with flutiform this month.

The Effect (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) study has been designed to investigate the superiority of flutiform 250/10 μg (2 puffs bid) and flutiform 125/5 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations over the 52-week treatment period.

"flutiform has already been approved as a maintenance therapy for asthma in adults and adolescents. We're excited with the progress that we've made to date with this combination and we believe that it also has the potential to be an important new treatment option for patients suffering from COPD," commented Prof.Dr. Karen Reimer, Managing Director, Mundipharma Research Limited.

This is the first large scale COPD study to evaluate two different doses of an ICS (Inhaled Corticosteroid) / LABA (Long-Acting Beta Agonist) combination, where the dose of both components is adjusted. The study will include recently developed COPD assessment tools which may further our understanding of this disease and will also evaluate serum biomarkers relevant to this multisystem disease. The study will provide useful new insights for clinicians into the management and assessment of COPD.

"The Mundipharma network of independent associated companies is committed to expanding our product offering in respiratory diseases including COPD, a chronic and debilitating disease which is predicted to become the third leading cause of death worldwide by 2030," added Georg Toufar, Chief Marketing Officer, Mundipharma International Ltd.

Study design

The primary objective of the Effect study is to show superiority in the efficacy of fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations during the 52-week treatment period.

The study is a Phase III multi-centre, randomised, double-blind and double dummy, placebo and active-controlled, parallel-group study comparing fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) and fluticasone propionate / formoterol fumarate  125/5 μg (2 puffs bid) versus formoterol fumarate dihydrate 12 μg (1 puff bid) in subjects with COPD.

Approximately 1,530 patients will be randomised in order to achieve 510 patients in each treatment group stratified for FEV1 % predicted category at baseline (FEV1 < 30% predicted, or 30-50 % predicted) and number of exacerbations in the previous year (≥ 2 or < 2).

Patients from approximately 15-20 countries will participate in the trial, including Bulgaria, Czech Republic, Germany, Hungary, Latvia, Macedonia, Poland, Romania, the Russian Federation, Slovakia, South Africa, South Korea, Spain, Ukraine and the United Kingdom.

flutiform is not currently licensed for the treatment of COPD

Notes to editors:

About flutiform

flutiform is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting β2-agonist (LABA) formoterol fumarate in a single aerosol.

In Europe, flutiform is indicated for adults and adolescents (aged ≥12 years) with asthma that is either not adequately controlled with an ICS plus an as-needed short-acting β2-agonist, or is already adequately controlled with an ICS plus LABA.

flutiform has been approved for the treatment of asthma in 21 European countries and is commercially available in 12: Germany, the UK, Italy, Belgium, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway, Slovakia and Sweden.  Further launches are anticipated during 2013/14.

About COPD

Chronic Obstructive Pulmonary Disease (COPD) - also called emphysema and/or chronic obstructive bronchitis - is a preventable lung disease caused by the long-term inhalation of pollutants, most commonly cigarette smoke, that progressively and permanently reduces the ability of adults to breathe well and maintain active lives. COPD is characterised by breathlessness (or dyspnoea), coughing, wheezing and increased sputum (mucus or phlegm) production. These symptoms, in particular shortness of breath, can restrict a patient's ability to perform normal daily activities.[2]

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 rheumatoid arthritis. These independent associated companies are known as Napp in the UK and Norpharma in Denmark.  For further information please visit: http://www.mundipharma.com.

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 http://www.skyepharma.com

Mundipharma International Corporation Limited is licensed by Jagotec AG, a Skyepharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas. flutiform is a registered trade mark of Jagotec AG.


  1. World Health Organisation. http://www.who.int/respiratory/copd/en/ (Accessed Sept 2013)
  2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. (Accessed: Sept 2013).

ZINC code: MINT FL-13049
Date of preparation: September 2013

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