Mundipharma has submitted a marketing application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the flutiform fluticasone/formoterol K-Haler breath-activated MDI for the treatment of asthma, the company said. The submission will be reviewed through the decentralized procedure.
In 2006, Mundipharma acquired European rights to flutiform from Skyepharma, which has recently announced that it will be acquired by Vectura, Earlier this year, Mundipharma acquired rights to the product in Central and South America and Mexico as well.
Mundipharma Regional Director of Europe Antony Mattessich commented, “The regulatory submission for flutiform K-Haler demonstrates our continued commitment to improve outcomes for patients with asthma by expanding our portfolio. The K-Haler device is a new platform technology, that is designed to be suitable for a range of respiratory products.”
Skyepharma CEO Peter Grant added, “flutiform K-Haler has been designed to build on the success of flutiform in the treatment of asthma, and its development has demonstrated Mundipharma’s strong commitment to expanding the flutiform franchise. Skyepharma has worked closely with Mundipharma in this development which we believe is an important potential extension of the flutiform range.”
Read the Mundipharma press release.
Read the Skyepharma press release.
