SkyePharma has announced that it has entered into a development, license, and marketing agreement for its Flutiform fluticasone and formoterol combination MDI with Sanofi in Mexico, Central America and South America. Sanofi will submit marketing authorization applications for Flutiform in the region, including in Brazil, Mexico, Venezuela, Argentina, and Colombia. The agreement includes milestone payments to SkyePharma for approval and sales, as well as an initial payment, “and a high single digit percentage royalty on net sales.”
Sanofi will manufacture the Flutiform that it markets in Central and South America and Mexico using SkyePharma materials. The company already manufactures the product on a contract basis for SkyePharma at its factory in Holmes Chapel, UK.
SkyePharma CEO Axel Müller commented: “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.”
Read SkyePharma press release.