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December 19, 2007 |
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SKYEPHARMA PLC: Completes Flutiform Efficacy Trial Enrollment SkyePharma PLC has completed enrollment of patients into the three double-blind efficacy trials currently underway for Flutiform(TM), its lead development product for the treatment of asthma. The three efficacy trials, involving nearly 1,400 patients, will provide core clinical data for the New Drug Application to be filed with the U.S. Food and Drug Administration and will also support the European Marketing Authorization Application. It is anticipated that the trials will be fully completed in April 2008. The trials are designed to demonstrate the superiority of Flutiform(TM) over the individual components and, in two of the studies, also over placebo. In November, the Company announced the successful completion of the Phase III, long-term, open label, safety study for Flutiform(TM), involving 472 patients and further to our announcement of Sept. 11, 2007, the additional clinical efficacy study, agreed with the FDA will commence in early 2008. This study will involve approximately 375 patients. "We have completed another important milestone in the development of Flutiform(TM) and remain focused on meeting all necessary requirements for the NDA filing," Dr Ken Cunningham, COO of SkyePharma said. Headquartered in London, SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) -- http://www.skyepharma.com/ -- develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now 12 approved products incorporating SkyePharma's technologies in the areas of oral, injectable, inhaled, and topical delivery supported by advanced solubilization capabilities. The net result for the continuing operations after finance charges and tax for the six months ended June 30, 2007, was a loss of GBP14.2 million (H1 2006: GBP16 million). The Group balance sheet as at June 30, 2007, shows GBP55.1 million in total shareholders' deficit. |
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