European Commission positive decision on flutiform®

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®.

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® 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.[i]

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® 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 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®. 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® 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 €73.0 million, of which €15.0 million was paid upfront, €3.0 million was paid on 31 December 2008, up to €15.0 million is due in installments as the product is launched in major European markets and up to €40.0 million is sales-related. It is anticipated that €8.0 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 €19 million of development costs principally related to the high strength version of flutiform®. 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 (£5.5 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.