UPDATE: SkyePharma Falls On Latest Flutiform Blow

24th Jun 2010 15:16

(Adds detail and analyst comment.) By Jason Douglas Of DOW JONES NEWSWIRES LONDON (Dow Jones)--Shares in SkyePharma PLC (SKP.LN) fell to a new low Thursday after the drug developer said its hopes of launching asthma treatment Flutiform in the U.S. were dealt what's likely to be a final blow. SkyePharma said the Food and Drug Administration said it must perform significant further clinical trials of Flutiform before it can be considered for approval. The company is now working with its advisers to determine whether there is "a viable way forward" to bring Flutiform to the U.S. market. Singer Capital Markets analyst Shawn Manning said it is almost certain SkyePharma will now stop U.S. development of Flutiform. At 1409 GMT, shares in SkyePharma were down 6.25 pence, or 18%, at 29 pence, after earlier touching 27 pence, an all-time low. London-based SkyePharma said during talks with the Food and Drug Administration, or FDA, it learned it would have to conduct a large safety study of Flutiform after it went on the market in addition to extra clinical work on the drug's effects at different doses. The drug was first submitted for FDA approval in 2007 but SkyePharma and partner Abbott Laboratories (ABT) were told to do another clinical trial. Further hold-ups followed. More recently, the prospects for Flutiform in the U.S. were clouded further by FDA worries about the class of asthma drugs it belongs to, which also includes big sellers like GlaxoSmithKline PLC's (GSK.LN) Advair. Flutiform, like Advair, is a combination of a corticosteroid and a long-acting beta agonist, both types of drugs. However, separately Thursday, the FDA approved Merck & Co. Inc.'s (MRK) Dulera. It is also a combination product for asthma. -By Jason Douglas, Dow Jones Newswires; 44-20-7842-9272; [email protected] (END) Dow Jones Newswires June 24, 2010 10:16 ET (14:16 GMT)