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Axcan announces record revenue of $70.6 million for the first ...

...The Therapeutic Products Directorate of Health Canada has indicated that additional clinical information would be needed prior to potential approval of SALOFALK 750 milligram tablets in Canada.

In light of these requirements, the Company has decided to withdraw its New Drug Submission for SALOFALK 750 milligram tablets in Canada, and will continue to focus efforts in Canada on the currently marketed SALOFALK 500 milligram tablets.

NCX-1000 Axcan and its partner, NicOx S.A., are developing NCX-1000, a patented, nitric oxide donating derivative of ursodiol, for the treatment of portal hypertension, a late-stage complication of chronic, advanced liver disease.

The Phase I clinical development program, which is designed to demonstrate the tolerability and safety of NCX-1000, has been completed, and the Company is pleased to report that results confirmed the safety profile of this drug.

A therapeutic proof-of-concept Phase IIa study is currently underway.

URSODIOL DISULFATE Axcan completed a proof-of-concept study in rats to evaluate the effect of ursodiol disulfate on the development of colonic tumors.

Acute and subchronic toxicity studies confirmed that the compound is safe and has no toxicity effect.

As previously announced, a clinical, single ascending dose Phase I study has recently been initiated to evaluate the safety, tolerability and preliminary pharmacokinetics of this new molecule.

This study should be completed in the second half of fiscal 2006.

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