SkyePharma’s share price has climbed almost 8% after the UK drug delivery firm announced that yet another late-stage study of its flagship asthma combination drug Flutiform has proved successful.
The company noted that its third Phase III efficacy study evaluating Flutiform (fluticasone and formoterol) for the treatment of mild to moderate asthma in adolescent and adult patients has met its primary endpoints. This is the latest of several studies being carried out in preparation for regulatory filing “and completes the original core clinical trial programme”, SkyePharma noted.
The 12-week study, called SKY2028-3-001 was conducted in centres across North America and Europe and included 475 patients. A top line analysis of key results showed that the levels of improvement in FEV1 (forced expiratory volume in the first second), showed statistically significant differences in favour of Flutiform compared with both fluticasone and formoterol taken alone. The data also demonstrated a significantly lower number of discontinuations due to lack of efficacy for the combo drug compared with placebo.
Ken Cunningham, Skyepharma’s chief operating officer and chief executive-designate, said that “we are very pleased with the progress being made with the development of Flutiform and now look forward to the results of the one remaining clinical efficacy trial required for the US filing”. This is being conducted by partner Kos Life Sciences, a unit of Abbott Laboratories, and that is on track “to be fully recruited in July and completed in the second half of this year,” he added, noting that a New Drug Application should be filed in the first quarter of 2009.
SkyePharma also noted that is continuing to explore options to refinance or renegotiate the terms of convertible bonds, an issue which has been the cause of some alarm for investors of late. Holders of these bonds could demand repayment of £69.6 million in May next year and a further £20 million in June 2010.
Last month, however, SkyePharma’s board said it “continues to have a reasonable expectation” that the convertible bonds issue can be sorted out “in a timely manner”.
