* “Few months” delay for EU filing
* Due to problem with patient assignment for study
* No cost implication for additional work
* U.S. filing due to come first (Adds analyst reaction, share price)
LONDON, Jan 21 (Reuters) - British drug delivery company SkyePharma SKP.L said there would be a few months delay to the filing of its lead product, asthma drug Flutiform, in Europe.
SkyePharma said in a statement on Wednesday it had been told by partner Mundipharma there would be a delay because of a “randomisation issue” in the way patients were assigned to the development studies, meaning more needed to be recruited.
However, there is no cost implication for SkyePharma as a result of the delay, it said. The drug is on track to be filed for U.S. approval in the first quarter of this year.
“To me, the main trigger is the U.S. filing and approval, because Europe has already fallen behind the U.S. in terms of filing plans,” said Jacob Plieth, an analyst at Edison Investment Research.
“I would say this is of secondary importance.”
Skyepharma shares fell as far as 148 pence in early trade, but had bounced back to 155 pence by 0855 GMT, 1.6 percent below Tuesday’s close. (Reporting by Ben Deighton, editing by Will Waterman)