New Combination for Asthma Shows Encouraging Results in Delivering Efficacy and Fast Onset of Action

CAMBRIDGE, England, September 19, 2010 - Data presented at the European Respiratory Society (ERS) congress
demonstrate that a new fixed-dose combination therapy of fluticasone
propionate (FP), an inhaled corticosteroid, and formoterol fumarate (FORM), a
long-acting beta2-agonist, is as effective in treating asthma as one of the
current market leaders in Europe, fluticasone propionate/salmeterol xinafoate
(FP/SAL), but has a more rapid onset of action(1). The FP/FORM combination
has also been shown to be more effective in controlling asthma symptoms than
FP alone(2).

Despite a range of available therapies, many asthma patients still
require unscheduled urgent care or emergency hospital admissions(3,4) which
suggests that there is a need for alternative treatment approaches which may
deliver more effective asthma management(5).

The FP/FORM combination brings together the attributes of the two
compounds: fluticasone propionate, the most widely prescribed inhaled
corticosteroid in Europe*(6) and formoterol fumarate, a long-acting
beta2-agonist characterised by a fast onset of action(7,8).

"There are still many challenges with achieving optimal control in asthma
patients - said Prof. David Price, Centre of Academic Primary Care,
University of Aberdeen, United Kingdom - The data presented today demonstrate
the good efficacy profile of the FP/FORM combination and reinforce its
potential to become an alternative treatment option for people with asthma."

There is evidence to suggest, that the type of device is one of the
factors which influences treatment outcomes in asthma patients(9). Data
presented at ERS from a GPRD retrospective study demonstrate that in
real-world combination therapy, patients using pressurised metered dose
inhaler (pMDI) appear to achieve better outcomes (asthma control and
exacerbations) than those using dry powder inhalers (DPIs)(10). In the
FP/FORM studies(1,2) both patient groups were administered their combination
in the pMDI.

The development of the new combination, filed with European regulatory
authorities in the first half of 2010, signals the entrance of Mundipharma in
the asthma marketplace, and their commitment to drive advancements in the
area of respiratory disease. The combination was developed by Mundipharma in
partnership with SkyePharma.

"The efforts of Mundipharma are focused on developing therapies which
address existing unmet needs in asthma and deliver clinical benefits that
enable patients to live better and more fulfilled lives through the optimal
control of their condition." - said Professor Dr. Karen Reimer, European R&D
Director at Mundipharma.

*Includes the following EU countries: Austria, Denmark, Finland, France,
Germany, Ireland, Italy, Netherlands, Spain, Sweden, Switzerland, UK

Notes to Editors

About the studies presented at ERS

FLT3501 was an open-label, parallel-group, multicentre study with FP/FORM
(250/10 microg) or FP/SAL (250/50 microg) administered twice daily. The
primary endpoint was mean morning pre-dose FEV1 at Week 12. Secondary
endpoints included time to onset of action. The study concluded that FP/FORM
was as effective as FP/SAL, with a least squares (LS) mean difference of
-0.06 L between treatments. FP/FORM time to onset of action was more rapid
than FP/SAL (hazard ratio: 1.64; 95% CI: 1.28, 2.10; p < 0.001; full analysis
population; FP/FORM: n = 101; FP/SAL: n = 100) and FP/FORM and FP/SAL safety
and tolerability profiles were similar(1).

FLT3503 was a double-blind, double-dummy, multicentre, parallel-group
study, with FP/FORM (500/20microg or 100/10 microg), FP+FORM (500microg +
24microg), or fluticasone propionate (FP) 500 microg alone (all twice daily).
The primary endpoint was change in mean morning pre-dose FEV1 from baseline
to end of treatment for FP/FORM 500/20 microg and FP+FORM.

Secondary endpoints from this study showed that FP/FORM 500/20microg
demonstrated superior efficacy to FP alone, with an increase from baseline in
mean morning pre-dose FEV1 to 2 hours morning post-dose at Week 8 of 0.517 L
(n = 154) and 0.396 L (n = 155), respectively (least squares [LS] mean of the
treatment difference: 0.120 L; 95% CI: 0.011, 0.230; p = 0.032). FP/FORM
500/20 microg was more effective than FP/FORM 100/10 microg (n = 155), with
an overall LS mean difference between treatments (from baseline; including
all study visits) of 0.085 L for change in morning pre-dose FEV1 (95% CI:
0.003, 0.168; p = 0.043). Additionally, FP/FORM 500/20 microg showed superior
efficacy to FP/FORM 100/10 microg and FP alone in multiple, clinically
important secondary endpoints. Safety and tolerability profiles were similar
across all groups(2).

GPRD retrospective study compared the real-world effectiveness of FP/SAL
via metered-dose inhaler (MDI) versus dry powder inhaler (DPI) in a UK
primary care asthma population. The co-primary endpoints were composite proxy
asthma control (no exacerbations or antibiotics for lower respiratory
infections) and exacerbations. The study demonstrated that using
logistic/poisson regression modelling, the odds of achieving asthma control
were significantly lower and exacerbation rates significantly higher among
DPI compared with MDI patients(10).

About Mundipharma

The Mundipharma/Napp/Norpharma independent associated companies,
including Mundipharma, Purdue and Napp, are privately owned companies and
joint ventures covering the world's pharmaceutical markets. The companies
worldwide are dedicated to bringing to patients with severe and debilitating
diseases the benefits of novel treatment options in fields such as rheumatoid
arthritis, moderate to severe pain, haemato-oncology and respiratory disease.

For more information: www.mundipharma.co.uk

About SkyePharma

Using its proprietary drug delivery technologies, SkyePharma
develops new formulations of known molecules to provide a clinical advantage
and life-cycle extension. SkyePharma has twelve approved products in the
areas of oral, inhalation and topical delivery. SkyePharma's products are
marketed throughout the world by leading pharmaceutical companies. For more
information, visit www.skyepharma.com.

References

1. Bodzenta-Lukaszyk A, Dymek, Mansikka H. Fluticasone
propionate/formoterol fumarate combination therapy is as effective as
fluticasone propionate/salmeterol xinafoate, but has a more rapid onset of
action in the treatment of asthma. Abstract presented at ERS, 18-22.09 2010
in Barcelona, Spain.

2. Bumbacea D, Pulka G, Dymek A et al. Fluticasone propionate/formoterol
fumarate combination therapy is more effective than fluticasone propionate
alone in the treatment of asthma. Abstract presented at ERS, 18-22.09 2010 in
Barcelona, Spain.

3. Partridge MR, van der Molen T, Myrseth SE et al. Attitudes and actions
of asthma patients on regular maintenance therapy: the INSPIRE study. BMC
Pulm Med 2006;6:13.

4. Cazzoletti L, Marcon A, Janson C et al. Asthma control in Europe: a
real-world evaluation based on an international population-based study. J
Allergy Clin Immunol 2007;120:1360-7.

5. Buhl R, Vogelmeier C. Budesonide/Formoterol maintenance and reliever
therapy: a new treatment approach for adult patients with asthma. Curr Med
Res Opin 2007;23:1867-78.

6. IMS Health, UK; MIDAS database, accessed May 2010.

7. Berger WE. The use of inhaled formoterol in the treatment of asthma,
Ann Allergy Asthma Immunol. 2006;97:24-33.

8. Prenner BM. Formoterol dry-powder inhaler for the treatment of asthma
and chronic obstructive pulmonary disease. Expert Opin. Pharmacother. 2007;
8(17):3069-3084.

9. Chrystyn H, Price D. Not all asthma inhalers are the same: factors to
consider when prescribing an inhaler. Prim Care Res J 2009;18:243-9.

10. Price D, Ali M, Burden A et al. Device type and real-world
effectiveness of combination therapy. Abstract presented at ERS, 18-22. 09
2010 in Barcelona, Spain.

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This release is for medical media only

For further information please contact: Bily Kuo, Bily.Kuo at mundipharma.co.uk, +44(0)1223-397-118; Wioletta Niznik, WNiznik at webershandwick.com, +44(0)2070-670-202