Skyepharma PLC Regulatory Approval (7928G)

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RNS Number : 7928G

Skyepharma PLC

03 July 2012

European Commission Positive Decision on flutiform(R)

- flutiform(R) to be Approved in 21 Countries in Europe -

LONDON, UK, 3 July, 2012 - SkyePharma PLC (LSE SKP) today announces that the European Commission has adopted a legally binding decision in favour of granting of marketing authorisations for flutiform(R).

This decision follows the positive opinion of the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") as announced on 20 April 2012. The European Commission decision is binding and the 21 member states in the decentralised procedure ("DCP") are now required to grant national marketing authorisations or approvals consistent with the decision.

In some countries it is anticipated that the national marketing authorisations will be granted shortly, typically between 1 and 3 months. In other countries negotiations will 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 as soon as possible through its network of independent associated companies once national approvals are granted and reimbursement confirmed.

Peter Grant, Chief Executive Officer of SkyePharma, commented: "The European Commission's positive decision on flutiform is excellent news for the Company and we look forward to launches across Europe in the second half of this year. To get a product of this complexity through to approval has been an immense achievement by SkyePharma and our partner Mundipharma. It is also a strong endorsement of the Group's capabilities in developing innovative and complex respiratory products and good news that a new treatment option will be available for many patients suffering from asthma across Europe."

"Asthma is a debilitating condition which affects millions of people across Europe, and its symptoms are still not optimally controlled," said Antony Mattessich, Regional Director Europe, Mundipharma International Limited. "We are very pleased that we can now obtain approvals in 21 countries in Europe and continue to plan for launch as soon as possible following the issuance of national marketing authorisations."

A novel combination, flutiform(R) combines fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting <BETA>(2) -agonist (LABA) in a single aerosol inhaler incorporating SkyePharma's proprietary SkyeDry(TM) technology. flutiform(R) will be indicated for the regular treatment of asthma in patients aged 12 years and over (50/5ug and 125/5ug strengths) and in adults (250/10ug strength) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting <BETA>(2) -agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA. (1)

The member states in the DCP were the UK, as reference member state, and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia and Sweden.

Additional information

The SkyePharma Group commenced development of flutiform(R) 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(R) for Europe and most other territories outside Japan and the Americas.

The Marketing Authorisation Application included a substantial package of chemistry, manufacturing and control data together with the results of eight phase I/II studies and nine phase III trials, which were conducted in a population of 4,500 patients, of which 1,900 received flutiform(R). The trials were designed to evaluate the safety and efficacy of the fluticasone/formoterol combination compared with fluticasone and formoterol alone, the two components administered concurrently and to a currently available combination asthma therapy, salmeterol/fluticasone.

SkyePharma is responsible for the supply of flutiform(R) to Mundipharma. The manufacturing processes have been validated and some initial launch stocks have been manufactured.

Financial information

The development and marketing agreement with Mundipharma includes milestones of up to EUR73.0 million, of which EUR15.0 million was paid upfront, EUR3.0 million was paid on 31 December 2008, up to EUR15.0 million is due in installments as the product is launched in major European markets and up to EUR40.0 million is sales-related. It is anticipated that EUR8.0 million of the launch milestones will be received in 2012 and half of these receipts will be applied as prepayments of the Paul Capital Note.

Under the development and marketing agreement the Group is entitled to royalties as a percentage escalating upwards from 10% of net sales. In the first four years following commercial launch in one of Europe's five largest markets the net royalties and sales milestones are subject to substantial partial reductions until Mundipharma recovers up to EUR19 million of development costs principally related to the high strength version of flutiform(R). Royalties are also subject to a cap which limits the aggregate amount of royalties and costs of product supplied to Mundipharma by SkyePharma to a maximum of 35% of net sales.

The European asthma market

According to IMS the preventative asthma/COPD European market size in 2010 was estimated to be U.S.$8.6 billion (GBP5.5 billion) with a four-year compound annual growth rate of 6.6%. Preventative treatment of asthma comprises well over half this market, which comprises anti-leukotrienes, ICS, ICS/LABAs, LAMAs and PDE-4 inhibitors. In 2010 European sales of ICS/LABAs totalled U.S.$4.8 billion.

-Ends-

For further information please contact:

 
 SkyePharma PLC 
 Peter Grant, Chief Executive Officer    [phone] 
 
 FTI Consulting 
 Jonathan Birt/ Julia Phillips/ 
  Susan Stuart                           [phone] 
 

Clinical evidence behind flutiform(R)

The EC recommendation was granted based on a regulatory package of eight phase I/II studies and nine phase III trials, which were conducted in a patient population of nearly 4,500, of whom 1,900 received flutiform(R).

The phase III clinical trials have demonstrated the efficacy, safety and tolerability profile of flutiform(R) 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 <MU>g b.i.d.) compared to the fluticasone/salmeterol combination (100/50 or 250/50 <MU>g 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 inhalers (4)

About SkyePharma

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products. Once flutiform(R) is launched 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 SmPC 
   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 

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