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Alizyme says Colal-pred submission date uncertain

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Date: Friday 29 Aug 2008

LONDON (ShareCast) - Drug developer Alizyme said timing of the Marketing Authorisation Application (MAA) for its ulcerative colitis treatment Colal-Pred is now uncertain.

The group said it had been anticipated that a MAA for COLAL-PRED would be submitted in the EU in the fourth quarter of 2008.

“There is now uncertainty over the timing of a submission. Submission of an MAA may result in restriction of indication, denial of approval or demands for additional data,” said Alizyme.

The group also said there can be not certainty of the outcome from the Phase II study of its metabolic product cetilistat by its Japanese partner Takeda, which is due to be reported this year.

“If successful, we anticipate that Takeda will apply to commence a Phase III study. However, this decision will be made by Takeda, and the ability to commence a study would be subject to regulatory approval, which may result in demands for additional data, amendments to the protocol or delay, and which is not certain,” it said.

For the half year, net losses after tax increased to £8.9m from £12.3m before.

The group also revealed that David Campbell is to step down from his role as finance director.

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