London, UK, July 28, 2011 – SkyePharma PLC (LSE: SKP) today announces that the Group ("SkyePharma") entered into an exclusive development, licensing and marketing agreement with Sanofi in Mexico, Central and South America for Flutiform ™, its product development for the treatment of asthma.
Under the agreement, SkyePharma is suitable for initial milestones, approvals and sales potentially worth several million US dollars and a royalty of high single digit percentage of net sales.
Under the agreement, Sanofi aims to pursue the marketing approval of Flutiform ™ throughout the region, including in Mexico, Brazil, Argentina, Venezuela and Colombia. Applications will be based on data entered in, and subject to the approval of the European Marketing authorization application ("MAA") for Flutiform ™ Filed by Mundipharma International Limited. Preparations continue to be made for the launch of Flutiform ™ potential in Europe in H2 2011.
Sanofi Flutiform ™ currently manufactures under contract for SkyePharma at its facility in Holmes Chapel, UK, and this provision was extended to allow for Sanofi to deliver Flutiform ™ and provide it directly to its group companies for Mexico, Central and South America using some ingredients and components supplied by SkyePharma.
Sanofi is the leading pharmaceutical company in Latin America and will strengthen its position within the market of asthma, with Flutiform ™, once approved.
Chief Executive Officer of SkyePharma, Axel Müller, said: "we are very pleased to have attracted a partner expert as licensee for Flutiform ™ in Mexico, Central and South America, and looking forward to working with Sanofi either as producer and licensee for Flutiform ™ we are continuing to make preparations with our partner Mundipharma, for the launch of potential Flutiform ™ in Europe this year."
For more information please contact:
SkyePharma PLC
Axel Müller, Chief Executive Officer
+ 44 207 881 0524
Peter Grant, Chief Financial Officer
Singer capital markets Limited
Shaun Dobson/Claes Spång
+ 44 203 205 7500
Financial dynamics
Jonathan Birt/Sue Quigley
+ 44 207 831 3113
About SkyePharma PLC
Using its technologies proprietary drug delivery, SkyePharma develops new formulations of molecules known to provide clinical benefit and life cycle extension. The Group has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed worldwide by leading pharmaceutical companies. For more information, visit www.skyepharma.com.
About Flutiform ™
Flutiform ™ is a fixed dose combination of fluticasone inhaled corticosteroid, a ("ICS") and beta agonist formoterol, a long duration of action ("LABA") in a Metered Dose inhaler (MDI). Flutiform ™ is licensed to Mundipharma International Ltd. in Europe and most other territories outside of Japan and the Americas and is licensed to Kyorin Pharmaceutical Company Ltd. in Japan. An application for marketing authorization for Flutiform ™ has been filed in Europe in March 2010 and is progressing in line with the expectations of the Board of Directors, and continue to launch preparations for its potential in the second half of 2011. Development of Flutiform ™ in Japan is making progress with two phase III studies, and the goal of the NEI Japanese filing by the end of March 2013.
Mo Noonan
Senior Manager
Financial dynamics
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