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Lundbeck stroke drug Desmoteplase not better than placebo in phase 3 UPDATE


Published :
Fri, 01 Jun 2007 07:59
By : Agencies
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(Updating with study details)

COPENHAGEN (Thomson Financial) - Danish pharmaceutical company Lundbeck AS said a phase 3 clinical study has shown no statistically significant difference in clinical outcome between patients treated with its stroke drug Desmoteplase and with placebo.

The findings will not influence the group's financial result for 2007, Lundbeck added.

The study was carried out by Lundbeck's partner PAION AG and Forest Laboratories Inc.

PAION said improvement of clinical outcome was found with 47.4 pct of patients treated with 90 mcg/kg Desmoteplase and 36.4 pct of patients treated with 125 mcg/kg Desmoteplase, compared to 46.0 pct in the placebo group.

Neither of the doses of Desmoteplase gave results statistically significantly different from placebo.

'These data are surprising and not consistent with previously observed patterns,' said PAION, adding that in-depth analyses are planned to better understand the data.

Forest is PAION's partner for Desmoteplase for North America, and Lundbeck for the rest of the world.

Danish daily Berlingske Business previously said the results of the Desmoteplase study may be decisive for Lundbeck, which in March announced it would discontinue development of the insomnia drug Gaboxadol.

gustav.sandstrom@thomson.com

gs/jfr

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