On 28 July, 2011 drug delivery technologies developer SkyePharma, announced that it had signed 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, 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. 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.
SkyePharma is eligible for a high single digit percentage royalty on net sales on achieving initial, approval and sales milestones potentially worth several million US dollars.
SkyePharma was advised in the negotiation of this agreement and the associated arrangements by Stuart Richards.