SkyePharma PLC announces that the Group has entered into an exclusive development, license and marketing agreement with Sanofi in Mexico, Central and South America for Flutiform, its lead development product for the treatment of asthma.

Under the agreement, SkyePharma is eligible for initial, approval and sales milestones potentially worth several million US dollars and a high single digit percentage royalty on net sales.

Under the agreement, Sanofi aims to pursue marketing authorisation applications for Flutiform throughout the region, including in Mexico, Brazil, Argentina, Venezuela and Colombia. The applications will be based on data included in, and subject to approval of, the European Marketing Authorisation Application (MAA) for Flutiform filed by Mundipharma International Limited. Preparations continue to be made for the potential launch of Flutiform in Europe in H2 2011.

Sanofi currently manufactures Flutiform under contract to SkyePharma at its factory in Holmes Chapel, UK, and this arrangement has been extended to allow Sanofi to manufacture Flutiform and supply it directly to its group companies for Mexico, Central and South America using certain ingredients and components supplied by SkyePharma.

Sanofi is the leading pharmaceutical company in Latin America, and will reinforce its position within the asthma market, with Flutiform, once approved.

SkyePharma's chief executive officer, Axel Müller, said: “We are very pleased to have attracted such an experienced partner as the licensee for Flutiform in Mexico, Central and South America, and we look forward to working with Sanofi as both manufacturer and licensee for Flutiform. We are continuing to make preparations with our partner Mundipharma, for the potential launch of Flutiform in Europe later this year.”

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage 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 throughout the world by leading pharmaceutical companies.

Flutiform is a fixed dose combination of fluticasone, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta agonist (LABA) in a Metered Dose Inhaler (MDI). Flutiform is licensed to Mundipharma International Ltd in Europe and most other territories outside Japan and the Americas and is licensed to Kyorin Pharmaceutical Company Ltd in Japan.  A marketing authorisation application for Flutiform was filed in Europe in March 2010 and is progressing in line with the Board's expectations, and preparations continue for its potential launch in the second half of 2011.  The development of Flutiform in Japan is making good progress with two Phase III studies underway, and the aim of filing the Japanese NDA by the end of March 2013.