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UPDATE 1-NPS Pharma says higher dose of Gattex misses goal

Thu Oct 11, 2007 10:22am EDT

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Oct 11 (Reuters) - NPS Pharmaceuticals Inc (NPSP.O) said a higher dosage of its experimental drug Gattex to treat short bowel syndrome was not significantly better than a dummy drug, but a lower dosage was successful.

Short Bowel Syndrome is a malabsorption disorder due to removal of a part of small intestine after an injury or illness.

The results from a late stage study showed only 25 percent of patients on a higher dosage responding and showing a trend in difference compared to those on a dummy drug, a difference which is not statistically significant.

NPS' stock fell more than 27 percent to $4.08 in morning trade, making it the biggest percentage loser on the Nasdaq.

The results showed a lower dosage of Gattex to be effective with 46 percent of the patients responding and showing a statistically significant reduction in parenteral nutrition compared to those on a dummy drug.

The company said it plans to meet with the U.S. Food and Drug Administration to discuss the approval for Gattex, given the positive results in the low-dose group and its orphan drug designation.

The study's criteria requires that the higher dosage group shows statistical significance before results of the lower dosage group could be considered, NPS said.

The study also did not show statistical difference in the incidence rates of adverse events or serious adverse events among treatment groups, when compared to the dummy drug, the company added. (Reporting by Niveditha Ravi in Bangalore)



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