Skyepharma has reported that in-market sales of the flutiform fluticasone/formoterol MDI for the first 6 months of 2015 have totaled €65.1 million, up from €28.4 million in the first half of 2014, and the directors now predict that flutiform revenues will exceed previous expectations for the year.
Skyepharma CEO Peter Grant commented, “”With a strong start to the year, Skyepharma is on track to deliver substantial growth in revenues in 2015, driven by products launched since March 2012. flutiform continues to gain momentum as its benefits are recognised by clinicians and patients in 30 countries around the world. Since H1 2014 we have seen further increases in revenues of Exparel and the GSK Ellipta range of products incorporating some of our proprietary technologies.”
He added, “We are on course to deliver a number of key objectives we set out at the start of the year, including growing revenues from approved products, scaling up production capacity for flutiform, further reducing our financing costs, improving balance sheet flexibility and progressing our internal R&D programmes where the net investment is weighted towards the second half of the year. We look forward to the rest of 2015 with confidence.”
flutiform has now been approved in 37 countries, but is not approved in the US. The inhaler is marketed by Kyorin in Japan, by Sanofi in Latin America, and by Mundipharma in Europe and most of the rest of the world. The company said that marketing applications have been submitted in an additional 13 countries in Asia, the Middle East, and Africa as of June 30, 2015. Columbia also has a marketing application for flutiform under review.
According to the report, Mundipharma has withdrawn its marketing application for flutiform for the treatment of asthma in pediatric patients after a notification from the MHRA that the procedure could not be finished within the specified timeframe. Mundipharma reported positive results from a Phase 3 study of flutiform for pediatric use in September 2014.
Skyepharma also said that it is developing a breath-actuated version of flutiform for Mundipharma, using a Mundipharma device. Other products in development include SKP-2075, a low-dose theophylline/steroid inhaler for COPD the company acquired from Pulmagen in 2014 and SKP-2076, “a novel inhalation product for a major respiratory disease which combines known chemical entities.”
Read the Skyepharma report.
