flutiform Receives Regulatory Approval in Germany

flutiform® Receives Regulatory Approval in Germany

Launch Anticipated Later This Year

LONDON, UK, 17 July, 2012 - SkyePharma PLC (LSE SKP) today announces that the regulatory authority in Germany, Bundesinstitut für Arzneimittel und Medizinprodukte (BfARM), has granted marketing authorisation for flutiform®, a combination product for the treatment of asthma. The launch of flutiform® in Germany is expected to take place later this year.

This approval follows the European Commission's decision, announced on 3 July 2012, to adopt a legally-binding decision in favour of the granting of marketing authorisations for flutiform®. Following the European Commission's decision the 21 member states in the decentralised procedure (DCP) are required to grant national marketing authorisations or approvals consistent with the decision.

Approval has already been granted in Cyprus. 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.

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

Peter Grant, Chief Executive Officer of SkyePharma, commented:

"We are extremely pleased flutiform has been approved by BfARM and will soon be available in Germany and Europe. Despite available treatment options, asthma continues to present a challenge to both patients and doctors. flutiform combines two of the most effective asthma medications available, offering patients a fast-acting combination treatment in an easy to use inhaler. We look forward to our partner Mundipharma launching flutiform 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. Following the launch of flutiform® the Group will be receiving 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