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Skyepharma PLC (SKYEF) Release: Positive Step Towards Marketing Authorisation For Flutiform® In Spain


1/22/2014 10:54:06 AM

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LONDON, UK, 22 January, 2014 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, today announces that a mutual recognition procedure covering flutiform® for Spain has been concluded successfully. Launch will follow once local regulatory, pricing and reimbursement procedures have been completed.

A milestone of €2.0 million (£1.7 million at current exchange rates) will be payable to Skyepharma from its European partner, Mundipharma, upon launch and Skyepharma is eligible to receive royalties on net sales.

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.

flutiform® has already been approved in 21 countries in Europe and launched in 13. flutiform® has further been launched by Mundipharma in Australia and Hong Kong and by Kyorin Pharmaceutical Co, Ltd in Japan. The product has also been approved in Israel and South Korea. Sanofi, Skyepharma’s licensee in Latin America, has initiated regulatory filings in the region.

Under its agreements with Mundipharma and Kyorin, Skyepharma is responsible for arranging the manufacture and supply of flutiform®, and has contracted with Sanofi to manufacture and package the product.

IMS state that the ICS/LABA combination market in Spain was worth approximately €370 million in the 12 months ending 30 September 2013.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

“We welcome this further development and the prospect of national approval of flutiform in Spain, which will complete the product’s approval in the five largest EU markets. We look forward to the launch in Spain by our partner Mundipharma in due course and to the opportunity to bring an effective new option for treatment of bronchial asthma to Spanish patients.”

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
Andrew Derodra, Chief Financial Officer +44 207 881 0524

FTI Consulting
Julia Phillips/Stephanie Cuthbert/Natalie Garland-Collins +44 207 831 3113

N+1 Singer
Shaun Dobson +44 207 496 3000
Clinical evidence supporting 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 15 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

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