AXCAN DISCONTINUES DEVELOPMENT OF ITOPRIDE FOR DYSPEPSIA

Axcan Pharma announced that results of a North American Phase III clinical study showed that Itopride, a drug developed for the treatment of functional dyspepsia, did not meet its primary endpoints. As these results, considered in conjunction with the previously announced results of the international Phase III study, are not supportive of further clinical evaluation of the drug in this indication, the company has decided not to pursue the clinical development of Itopride for the treatment of functional dyspepsia, or abdominal discomfort.

This study did not demonstrate a statistically significant effect of Itopride in improving the symptoms of upper abdominal pain and fullness, as assessed by the Leeds Dyspepsia Questionnaire, whether under the predefined initial statistical analysis plans for the study, or the revised statistical analysis plan. In addition, the trial did not demonstrate a statistically significant finding in terms of patient global assessment questionnaire-measured efficacy.

"Although we are disappointed by these results, we will continue to thoroughly analyze the data from this study," said Frank Verwiel, president and CEO of Axcan. "This decision should result, beginning in fiscal 2007, in a reduction in research and development expenses associated with Itopride in this indication."