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Skyepharma launches asthma drug, flutiform in Italy

London, UK
Saturday, June 22, 2013, 16:00 Hrs  [IST]

Skyepharma PLC, the expert oral and inhalation drug delivery company, announced that following regulatory approval and agreement on pricing reimbursement, it has launched flutiform in Italy.

Mundipharma will be marking the flutiform, which in Italy will be called flutiformo, 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.


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