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SkyePharma Inc. (SKYE) Release: flutiform® Launch in Italy Triggers €2 Million Milestone From Marketing Partner Mundipharma AG


6/20/2013 8:49:52 AM

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LONDON, UK, 20 June, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, announces that, following regulatory approval and agreement on pricing reimbursement, flutiform® has now been launched in Italy.

flutiform®, which in Italy will be called flutiformo®, will be marketed by Mundipharma for the treatment of asthma. A milestone of €2.0 million (£1.6 million) is now due to Skyepharma, which will also receive royalties on net sales. Half of the milestone will be paid by Skyepharma to Paul Capital as a pre-payment of the Paul Capital Note.

flutiform® combines for the first time in Europe the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the most widely prescribed ICS (Inhaled Corticosteroid), fluticasone.

Since the decision by the European Commission in favour of granting marketing authorisations for flutiform® in 2012, flutiform® has been approved in all 21 countries of the decentralised procedure and launched in ten countries: Germany, the UK, Italy, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway and Sweden. For the remaining 11 countries, including France, further launches are anticipated during 2013/14 once pricing and reimbursement processes are concluded. The Group’s development, marketing and distribution partner for flutiform®, Mundipharma International Corporation Limited (“Mundipharma”), aims to continue to launch flutiform® as soon as possible through its network of independent associated companies once national approvals are granted and, where relevant, pricing and reimbursement confirmed.

According to IMS, the ICS/LABA combination market in Italy was worth approximately €291 million in 2012.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

“The launch of flutiform in Italy follows encouraging feedback from Mundipharma on progress made in the initial launch markets, which include Germany and the UK. We look forward to the continued roll-out of flutiform across Europe, providing asthma patients with a new and effective treatment option.”

A novel combination, flutiform® combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting ß2-agonist (LABA) in a single aerosol inhaler incorporating Skyepharma’s proprietary SkyeDry™ technology. flutiform® is 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 ß2-agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.1

For further information please contact:

Skyepharma PLC

Peter Grant, Chief Executive Officer +44 207 881 0524

FTI Consulting

Julia Phillips/Susan Stuart +44 207 831 3113

N+1 Singer

Shaun Dobson/Jennifer Wyllie +44 207 496 3000

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

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 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.

1flutiform® Summary of Product Characteristics

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

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

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

Natalie Garland-Collins

Consultant

Strategic Communications

F T I Consulting

+44 (0)20 7269 7121 direct

Natalie.Garland-Collins@fticonsulting.com

Holborn Gate, 26 Southampton Buildings

London, WC2A 1PB

www.fticonsulting.com

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