Mundipharma Commences COPD Trial

Cambridge, England (ots/PRNewswire) -

Mundipharma Research Limited (Mundipharma) announced today a major
milestone in the development programme of flutiform(R)(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 mug (2 puffs bid) and flutiform 125/5 mug (2 puffs
bid) compared with formoterol 12 mug (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 mug (2 puffs bid) compared with formoterol 12 mug (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 mug (2
puffs bid) and fluticasone propionate / formoterol fumarate 125/5 mug
(2 puffs bid) versus formoterol fumarate dihydrate 12 mug (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 (greater
than or equal to 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 beta2-agonist (LABA)
formoterol fumarate in a single aerosol.

In Europe, flutiform is indicated for adults and adolescents (aged
greater than or equal to12 years) with asthma that is either not
adequately controlled with an ICS plus an as-needed short-acting
beta2-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.

References:

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

ots Originaltext: Mundipharma International
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Charlotte James,
charlotte.james@mundipharma.co.uk, Tel: +44 (0)1223 397162 ; Gill
Dunn ,
gill@auroracomms.com , Tel: +44 (0)20 7148 4175