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news.SkyePharma has executed patient recruitment in two Phase III studies in Japan, to assess efficacy and safety of Flutiform.
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Flutiform HFA-MDI is said to be a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler (MDI).
SkyePharma said that the two Phase III trials will provide clinical data to support the regulatory process in Japan.
One of the trials is a multicentre, comparative study designed to confirm the efficacy and safety of Flutiform compared with monotherapy, and the second is a study to confirm the safety and efficacy of Flutiform.
Under the agreement with Kyorin for Japan, development and approval milestones worth several million pounds are payable to SkyePharma.
The Group continues to make preparations for a potential launch of Flutiform in Europe in 2011.
SkyePharma CEO Axel Muller said that they are pleased to report continued progress, ahead of schedule, with the development programme for Flutiform in Japan.
"We look forward to working with our partner, Kyorin, as we move a step closer towards commercialising Flutiform in this important and growing market," Muller said.