Product Launch

flutiform® Update

LONDON, UK, 4 September, 2012 - SkyePharma PLC (LSE SKP) today reports that, at the European Respiratory Society annual congress being held in Vienna, Austria, 1-5 September 2012, Mundipharma GmbH has announced that it expects to launch flutiform® in Germany in September 2012. 

Since announcing the Group's interim results on 23 August, further marketing authorisations for flutiform® have been granted to Mundipharma, SkyePharma's development, marketing and distribution partner in Europe. flutiform® is now authorised in eight European countries: Germany, UK, Austria, Cyprus, the Netherlands, Norway, the Slovak Republic and Sweden. The Group will benefit from two milestones of €4.0 million (£3.2 million) each when flutiform® is launched in Germany and the UK.

As announced on 3 July 2012, the European Commission ("EC") adopted a legally binding decision in favour of granting of marketing authorisations for flutiform®. This decision is binding on the 21 member states in the decentralised procedure ("DCP").

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. flutiform® will be 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. 1

-Ends-

For further information please contact:

Clinical evidence behind flutiform®

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 a substantial part of the clinical trials. In 2006 the Group appointed Mundipharma International Corporation Limited as the development partner and authorised distributor of flutiform® for Europe and most other territories outside Japan and the Americas.

The European Commission decision was based on a regulatory package of nine Phase I/II studies and nine Phase III trials, which were conducted in a patient population of approximately 5,000, of whom 1,900 received flutiform®.

The phase III clinical trials have demonstrated the efficacy and tolerability profile of flutiform® across a range of asthma severities and in comparison with two currently available combination therapies for asthma (fluticasone/salmeterol and budesonide/formoterol). 1,2,3,4

Phase III clinical trial data (8-12 weeks) demonstrated that the new combination:

- is more effective in improving asthma symptom scores, including an improvement in the percentage of symptom-free days and awakening-free nights, compared with a similar dose of fluticasone alone 4

- provides similar improvements in lung function parameters, control of asthma symptoms and similar level of exacerbations compared to its individual components administered concurrently via separate inhalers 4

- has a more rapid onset of bronchodilatory action than the fluticasone/salmeterol combination as defined by the first time point post-dose at which FEV1 was at least 12 percent greater than the pre-dose value. The superiority of fluticasone/formoterol combination (100/10 or 250/10 μg b.i.d.) compared to the fluticasone/salmeterol combination (100/50 or 250/50 μg b.i.d.) was shown over a 12-week study period (HR 1.64) 3

- has a tolerability profile similar to that of its individual components administered concurrently via separate inhalers 4

About SkyePharma

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products. The Group receives revenues from thirteen approved products in the areas of inhalation, oral, topical and injectable delivery as well as generating income from the development of further products and technology licenses. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

About Mundipharma

The Mundipharma 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.

1. flutiform® Summary of Product Characteristics

2. Bodzenta-Lukaszyk A, R Buhl, et al. Eur Respir J 2011a;38:153s

3. Bodzenta-Lukaszyk A, Dymek A et al. BMC Pulm Med J. 2011;11:28

4. Bodzenta-Lukaszyk A, Pulka et al. Respir Med J. 2011;105(5):674-82