LONDON, UK, 1 December, 2014 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug development company, today announces that following regulatory approval and agreement on pricing reimbursement, flutiform® has now been launched in Spain for the treatment of bronchial asthma. It has also been launched in Italy as Abriff® under a co-marketing agreement.
Following the launch in Spain, a milestone of €2.0 million (£1.6 million at current exchange rates) is now payable to the Group by its licensee, Mundipharma International Corporation Limited (“Mundipharma”), together with royalties on net sales and revenues on product supply.
flutiform® and Abriff® combine the fast-acting long-acting beta agonist (LABA) formoterol with the most widely prescribed inhaled corticosteroid (ICS) fluticasone.
Following the launch in Spain, flutiform® is now available in 20 countries in Europe, including the five largest markets, with approvals in a further three countries. flutiform® has also been launched by Mundipharma in Australia, Hong Kong, Israel, Singapore and South Korea and by Kyorin Pharmaceutical Co, Ltd (“Kyorin”) in Japan.
In Italy, Abriff® has been launched by Mundipharma’s co-marketing partner, Zambon Italia srl. Mundipharma Italy previously launched the same fixed combination product under the flutiformo® trade mark in June 2013 and retains the exclusive right in the territory to promote and distribute flutiformo®. The Group will receive royalties on net sales and revenues on product supply under both names.
According to IMS Health, the ICS/LABA combination markets, measured in in-market sales, in Spain and Italy were worth approximately €356 million and €293 million respectively for the 12 months ended 30 June 2014.
Peter Grant, Chief Executive Officer of Skyepharma, commented: “flutiform is now available in the five largest European markets and represents a new treatment option for clinicians and asthma patients in Spain. With this latest launch in a key market and an enhanced distribution network in Italy, we look forward to continued progress.”
flutiform® combines fluticasone propionate (fluticasone), an ICS, and formoterol fumarate (formoterol), a 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 beta agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.
-Ends-
For further information please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 (0)20 7881 0524
Jonathan Birt, Investor and Media Relations
+44 (0)7860 361746
N+1 Singer
Shaun Dobson/Gillian Martin/Jen Boorer
+44 (0)20 7496 3000
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 (0)20 3727 1000
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 16 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 network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and inflammatory conditions. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For further information please visit: www.mundipharma.com.
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Following the launch in Spain, a milestone of €2.0 million (£1.6 million at current exchange rates) is now payable to the Group by its licensee, Mundipharma International Corporation Limited (“Mundipharma”), together with royalties on net sales and revenues on product supply.
flutiform® and Abriff® combine the fast-acting long-acting beta agonist (LABA) formoterol with the most widely prescribed inhaled corticosteroid (ICS) fluticasone.
Following the launch in Spain, flutiform® is now available in 20 countries in Europe, including the five largest markets, with approvals in a further three countries. flutiform® has also been launched by Mundipharma in Australia, Hong Kong, Israel, Singapore and South Korea and by Kyorin Pharmaceutical Co, Ltd (“Kyorin”) in Japan.
In Italy, Abriff® has been launched by Mundipharma’s co-marketing partner, Zambon Italia srl. Mundipharma Italy previously launched the same fixed combination product under the flutiformo® trade mark in June 2013 and retains the exclusive right in the territory to promote and distribute flutiformo®. The Group will receive royalties on net sales and revenues on product supply under both names.
According to IMS Health, the ICS/LABA combination markets, measured in in-market sales, in Spain and Italy were worth approximately €356 million and €293 million respectively for the 12 months ended 30 June 2014.
Peter Grant, Chief Executive Officer of Skyepharma, commented: “flutiform is now available in the five largest European markets and represents a new treatment option for clinicians and asthma patients in Spain. With this latest launch in a key market and an enhanced distribution network in Italy, we look forward to continued progress.”
flutiform® combines fluticasone propionate (fluticasone), an ICS, and formoterol fumarate (formoterol), a 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 beta agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.
-Ends-
For further information please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 (0)20 7881 0524
Jonathan Birt, Investor and Media Relations
+44 (0)7860 361746
N+1 Singer
Shaun Dobson/Gillian Martin/Jen Boorer
+44 (0)20 7496 3000
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 (0)20 3727 1000
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 16 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 network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and inflammatory conditions. They are also committed to independent thinking and ground breaking solutions. Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers cutting-edge treatments to meet the most pressing needs of healthcare professionals and patients. For further information please visit: www.mundipharma.com.
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