Flutiform Positive Outcome

Positive opinion on flutiform® in Europe from the CHMP

LONDON, UK, 20 April, 2012 - SkyePharma PLC (LSE SKP) today announces that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMA") has issued a positive opinion recommending the granting of a marketing authorisation for flutiform® (fluticasone propionate/formoterol fumarate).

The decentralised procedure ("DCP") of the marketing authorisation application ("MAA") for flutiform® was referred to the CHMP for arbitration because a concerned member state did not agree with the positive benefit/risk assessment made by the reference member state, the United Kingdom, during the DCP. The positive opinion adopted by the CHMP will now go through the standing committee procedure which, in the absence of any further issues, will be converted into a legally binding decision by the European Commission, a process which, typically, takes 2 to 3 months. The standing committee decision would be binding in its entirety on all 21 concerned member states involved in the DCP, which includes the UK, Germany, France and Italy, and they would implement the decision through granting of national marketing authorisations or approvals.

In a number of countries negotiations will also be required with national pricing and reimbursement authorities before the product can be made commercially available. In other countries it is anticipated that the national marketing approvals would be granted shortly after the decision is issued (these approvals can typically take between 1 and 3 months). The Group's development, marketing and distribution partner, Mundipharma, aims to launch as soon as possible after national approvals are granted and reimbursement confirmed.

Peter Grant, Chief Executive Officer of SkyePharma, said: "The positive opinion of the CHMP is an important step forward for the development of flutiform and we look forward to receiving the final decision from the EMA in due course. This is a strong endorsement of our capabilities in developing innovative and complex respiratory products like flutiform. It is also good news that we are now on track for a new treatment option to 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 the CHMP has adopted a positive opinion and continue to plan for launch as soon as possible following a final decision and national marketing authorisations."

The newcombination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting β2-agonist (LABA) therapy, is delivered via a single aerosol inhaler and incorporates SkyePharma's proprietary SkyeDry™ technology. The MAA has sought approval of an indication for the regular treatment of asthma when use of a combination ICS/LABA product is appropriate. A combination therapy is suitable for patients not adequately controlled with ICSs and 'as required' inhaled short-acting β2-agonists, or for patients already adequately controlled on both an ICS and a LABA.

The MAA 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, two components administered concurrently and to a currently available combination asthma therapy, salmeterol/fluticasone.

The concerned 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 conceived the concept 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.

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

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. 

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 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.

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About SkyePharma

Using its multiple drug delivery technologies and expertise, SkyePharma creates enhanced versions of pharmaceutical products. The Group has eleven approved products in the areas of oral and topical delivery as well as important license and revenue-generating arrangements in inhalation and injectable technologies. 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.co.uk