SkyePharma has seen an upturn in its shattered share price after the company said that two more late-stage studies for its flagship asthma combination drug Flutiform have been successfully completed.
The studies were undertaken by SkyePharma’s marketing partner Mundipharma, and the first of them, involving 182 patients with mild to moderate-severe persistent and reversible asthma, found Flutiform (fluticasone and formoterol) was not statistically inferior to GlaxoSmithKline’s blockbuster Seretide (fluticasone and salmeterol). The analysis showed that there was an improvement in lung function in both treatment groups.
The second study analysed 196 adult and adolescent patients suffering from mild to moderate-severe asthma, confirmed that Flutiform was not inferior to its individual components, fluticasone and formoterol. Chief operating officer and chief executive-designate Ken Cunningham said the firm was delighted that “along with the three Phase III pivotal efficacy studies conducted for New Drug Application submission [in the USA], we now have two further Phase III studies for European regulatory submission that have met their primary endpoints”.
The news is very welcome for SkyePharma which has seen its shares slump to the 3 pence mark in the last two weeks. That collapse was caused by the UK drug delivery firm announcing that attempts to refinance or renegotiate the terms of convertible bonds have met with failure.
Holders of the bonds could demand repayment of £69.6 million in May next year and a further £20 million in June 2010, which would leave the firm crippled financially. However Mr Cunningham told PharmaTimes a fortnight ago that alternatives are being explored to resolve the problem.
