Regulatory Approval

flutiform® Receives UK Regulatory Approval

Launch Anticipated Later This Year

LONDON, UK, 23 August, 2012 - SkyePharma PLC (LSE SKP) today announces that the UK regulatory authority, the Medicines and Healthcare product Regulatory Agency (MHRA), has granted marketing authorisation for flutiform®, a combination product for the treatment of asthma. The UK launch of flutiform® is expected to take place later this year.

The UK marketing authorisation for flutiform®follows the European Commission's decision announced on 3 July 2012. The European Commission's decision is binding on the 21 member states in the decentralised procedure (DCP).

Marketing authorisations have already been granted in Germany, Cyprus, the Netherlands and the Slovak Republic. It is anticipated that further national marketing authorisations will be granted in some countries shortly. In other countries negotiations will also be required with national pricing and reimbursement authorities before the product can be made commercially available. The Group's development, marketing and distribution partner, Mundipharma International Corporation Limited, aims to launch flutiform® in each country through its network of independent associated companies as soon as possible once national approvals are granted and where required, reimbursement confirmed. Mundipharma's UK independent associate is Napp Pharmaceuticals Limited.

A further milestone of €4.0 million is due to SkyePharma once flutiform® has been launched in the UK. Half of this amount will be allocated as prepayments of the Paul Capital Note.

Peter Grant, Chief Executive Officer of SkyePharma, commented:

"Approval of flutiform by the UK regulators, MHRA, is further good news for the team at SkyePharma, many of whom have played an important role in developing flutiform. We are pleased that flutiform will soon be available in the UK and many other countries in Europe, providing patients with an effective treatment option and look forward to the continued roll-out of this important product across Europe."

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

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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, safety 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 alone4

- 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 inhalers4

- 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 safety and tolerability profile similar to that of its individual components administered concurrently via separate inhalers4

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.

About Napp Pharmaceuticals Limited

Napp Pharmaceuticals Limited is a UK pharmaceutical company that is committed to long-term support of the respiratory community using innovative approaches to treatments and investment in the support and education of healthcare professionals and patient groups working in this disease area. Napp Pharmaceuticals Limited builds on previous respiratory experience, including the introduction of Phyllocontin® Continus® and Uniphyllin® Continus® tablets, the world's first prolonged release formulations of aminophylline and theophylline, which are recommended in the BTS/SIGN Guidelines. Napp Pharmaceuticals Limited also has a strong heritage in the area of pain management and has been investing in research to further the understanding and treatment of pain for over 30 years. Napp Pharmaceuticals Limited is based on the Cambridge Science Park, employing over 700 people at this site. At the end of 2010, Napp Pharmaceuticals Limited was ranked the 15th largest pharmaceutical company in the UK based on GP prescription sales (IMS Health data) and ranked in the top 25 of the Times Top 100 Companies to work for in 2011. For more information: www.napp.co.uk.

1flutiform® Summary of Product Characteristics

2Bodzenta-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