Skyepharma has announced that Spain has completed a mutual recognition procedure regarding Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The European Commission approved Flutiform in July 2012.
The company also said that its European partner Mundipharma plans to launch the product in Spain after pricing and reimbursement have been determined. The approval triggers a €2.0 million milestone payment from Mundipharma to Skyepharma.
According to Skyepharma, Sanofi is manufacturing and packaging the product for the European and Japanese markets in addition to its own territory. Sanofi licensed Flutiform in Mexico, Central America, and South America in 2011.
Skyepharma CEO Peter Grant said, “We welcome this further development and the prospect of national approval of Flutiform in Spain, which will complete the product’s approval in the five largest EU markets. We look forward to the launch in Spain by our partner Mundipharma in due course and to the opportunity to bring an effective new option for treatment of bronchial asthma to Spanish patients.”
Read the Skyepharma press release.
