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Intercell sees U.S. JE vaccine approval early 09

Mon Dec 29, 2008 3:50am EST

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VIENNA, Dec 29 (Reuters) - Austrian biotech firm Intercell (ICEL.VI) said on Monday it expects U.S. approval for its Japanese Encephalitis (JE) vaccine to move into early 2009, later than expected.

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The company, which had hoped the U.S. Food and Drug Administration (FDA) would approve the vaccine by the end of 2008, said the delay should not cause problems for its overall timeline for the vaccine.

"Although our year end target date for approval in the U.S. will be missed we are very confident that we will be able to obtain approval in time to provide this important vaccine to U.S. travellers and military personnel according to our original timelines," CEO Gerd Zettlmeissl said in a statement.

The company also said it has started a phase II clinical trial for a vaccine against Pseudomonas aeruginosa. (Reporting by Sylvia Westall; Editing by Hans Peters)



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